Trial Outcomes & Findings for An 8-week Dose Ranging Study of CHF 718 pMDI in Asthmatic Subjects (NCT NCT03084718)
NCT ID: NCT03084718
Last Updated: 2021-12-14
Results Overview
Change from baseline in pre-dose morning FEV1 (average of pre-dose FEV1 measurements) at Week 8. Spirometry, used to measure FEV1, was performed according to internationally accepted standards. Definitions: Baseline=Baseline values for pre-dose FEV1 were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FEV1=Forced expiratory volume in the 1st second;
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
610 participants
Primary outcome timeframe
Baseline, Week 8
Results posted on
2021-12-14
Participant Flow
Participant milestones
| Measure |
Treatment A (CHF 718 pMDI 100 µg TDD)
CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;
CHF 718 pMDI 50 μg/actuation: 1 inhalation twice daily (BID); TDD of BDP: 100 μg;
|
Treatment B (CHF 718 pMDI 400 µg TDD)
CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;
CHF 718 pMDI 100 μg/actuation: 2 inhalations BID; TDD of BDP: 400 μg;
|
Treatment C (CHF 718 pMDI 800 µg TDD)
CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;
CHF 718 pMDI 100 μg/actuation: 4 inhalations BID; TDD of BDP: 800 μg;
|
Treatment D (Placebo)
Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations 2 times a day (BID);
|
Treatment E (QVAR^® 320 µg TDD)
Beclomethasone dipropionate Hydrofluoroalkane (HFA) (QVAR\^®), Active Control
Beclomethasone dipropionate Hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR\^® 80 μg/actuation: 2 inhalations BID;
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
120
|
120
|
122
|
124
|
124
|
|
Overall Study
COMPLETED
|
109
|
110
|
110
|
110
|
120
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
12
|
14
|
4
|
Reasons for withdrawal
| Measure |
Treatment A (CHF 718 pMDI 100 µg TDD)
CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;
CHF 718 pMDI 50 μg/actuation: 1 inhalation twice daily (BID); TDD of BDP: 100 μg;
|
Treatment B (CHF 718 pMDI 400 µg TDD)
CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;
CHF 718 pMDI 100 μg/actuation: 2 inhalations BID; TDD of BDP: 400 μg;
|
Treatment C (CHF 718 pMDI 800 µg TDD)
CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;
CHF 718 pMDI 100 μg/actuation: 4 inhalations BID; TDD of BDP: 800 μg;
|
Treatment D (Placebo)
Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations 2 times a day (BID);
|
Treatment E (QVAR^® 320 µg TDD)
Beclomethasone dipropionate Hydrofluoroalkane (HFA) (QVAR\^®), Active Control
Beclomethasone dipropionate Hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR\^® 80 μg/actuation: 2 inhalations BID;
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
4
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
3
|
5
|
5
|
8
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
1
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Randomization error; E-diary non-compliance; Complications with device use
|
1
|
0
|
1
|
2
|
0
|
Baseline Characteristics
Explain why number analyzed in row differs from overall. This was a trial with asthma patients. Only prior smokers were anlayzed for duration of smoking.
Baseline characteristics by cohort
| Measure |
Treatment A
n=118 Participants
CHF 718 pMDI 100 µg TDD
|
Treatment B
n=116 Participants
CHF 718 pMDI 400 µg TDD
|
Treatment C
n=120 Participants
CHF 718 pMDI 800 µg TDD
|
Treatment D
n=124 Participants
Placebo Control
|
Treatment E
n=124 Participants
Beclomethasone dipropionate Hydrofluoroalkane (HFA) (QVAR\^®), Active Control
Beclomethasone dipropionate Hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg;
QVAR® 80 μg/actuation: 2 inhalations BID, Total Daily Dose (TDD) of BDP: 320 μg;
|
Total
n=602 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=118 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=120 Participants
|
2 Participants
n=124 Participants
|
0 Participants
n=124 Participants
|
2 Participants
n=602 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
97 Participants
n=118 Participants
|
101 Participants
n=116 Participants
|
107 Participants
n=120 Participants
|
110 Participants
n=124 Participants
|
105 Participants
n=124 Participants
|
520 Participants
n=602 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=118 Participants
|
15 Participants
n=116 Participants
|
13 Participants
n=120 Participants
|
12 Participants
n=124 Participants
|
19 Participants
n=124 Participants
|
80 Participants
n=602 Participants
|
|
Age, Continuous
|
50.2 years
STANDARD_DEVIATION 13.58 • n=118 Participants
|
48.1 years
STANDARD_DEVIATION 14.38 • n=116 Participants
|
48.2 years
STANDARD_DEVIATION 13.83 • n=120 Participants
|
45.4 years
STANDARD_DEVIATION 16.17 • n=124 Participants
|
48.8 years
STANDARD_DEVIATION 14.24 • n=124 Participants
|
48.1 years
STANDARD_DEVIATION 14.52 • n=602 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=118 Participants
|
77 Participants
n=116 Participants
|
76 Participants
n=120 Participants
|
72 Participants
n=124 Participants
|
77 Participants
n=124 Participants
|
376 Participants
n=602 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=118 Participants
|
39 Participants
n=116 Participants
|
44 Participants
n=120 Participants
|
52 Participants
n=124 Participants
|
47 Participants
n=124 Participants
|
226 Participants
n=602 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
34 Participants
n=118 Participants
|
34 Participants
n=116 Participants
|
30 Participants
n=120 Participants
|
40 Participants
n=124 Participants
|
28 Participants
n=124 Participants
|
166 Participants
n=602 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=118 Participants
|
82 Participants
n=116 Participants
|
90 Participants
n=120 Participants
|
84 Participants
n=124 Participants
|
96 Participants
n=124 Participants
|
436 Participants
n=602 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=118 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=124 Participants
|
0 Participants
n=124 Participants
|
0 Participants
n=602 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=118 Participants
|
0 Participants
n=116 Participants
|
1 Participants
n=120 Participants
|
1 Participants
n=124 Participants
|
0 Participants
n=124 Participants
|
3 Participants
n=602 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=118 Participants
|
1 Participants
n=116 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=124 Participants
|
2 Participants
n=124 Participants
|
4 Participants
n=602 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=118 Participants
|
1 Participants
n=116 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=124 Participants
|
0 Participants
n=124 Participants
|
1 Participants
n=602 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=118 Participants
|
23 Participants
n=116 Participants
|
28 Participants
n=120 Participants
|
21 Participants
n=124 Participants
|
24 Participants
n=124 Participants
|
123 Participants
n=602 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=118 Participants
|
82 Participants
n=116 Participants
|
84 Participants
n=120 Participants
|
93 Participants
n=124 Participants
|
93 Participants
n=124 Participants
|
430 Participants
n=602 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=118 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=124 Participants
|
0 Participants
n=124 Participants
|
0 Participants
n=602 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=118 Participants
|
9 Participants
n=116 Participants
|
7 Participants
n=120 Participants
|
9 Participants
n=124 Participants
|
5 Participants
n=124 Participants
|
41 Participants
n=602 Participants
|
|
Region of Enrollment
United States
|
118 participants
n=118 Participants
|
116 participants
n=116 Participants
|
120 participants
n=120 Participants
|
124 participants
n=124 Participants
|
124 participants
n=124 Participants
|
602 participants
n=602 Participants
|
|
Weight
|
83.2 kg
STANDARD_DEVIATION 14.9 • n=118 Participants
|
77.9 kg
STANDARD_DEVIATION 15.6 • n=116 Participants
|
79.5 kg
STANDARD_DEVIATION 14.5 • n=120 Participants
|
80.5 kg
STANDARD_DEVIATION 15.5 • n=124 Participants
|
78.8 kg
STANDARD_DEVIATION 14.7 • n=124 Participants
|
80.0 kg
STANDARD_DEVIATION 15.1 • n=602 Participants
|
|
Height
|
169.6 cm
STANDARD_DEVIATION 9.5 • n=118 Participants
|
168.2 cm
STANDARD_DEVIATION 9.2 • n=116 Participants
|
167.8 cm
STANDARD_DEVIATION 8.4 • n=120 Participants
|
170.0 cm
STANDARD_DEVIATION 9.8 • n=124 Participants
|
167.9 cm
STANDARD_DEVIATION 9.7 • n=124 Participants
|
168.7 cm
STANDARD_DEVIATION 9.4 • n=602 Participants
|
|
Body Mass Index (BMI)
|
28.9 kg/m^2
STANDARD_DEVIATION 4.0 • n=118 Participants
|
27.4 kg/m^2
STANDARD_DEVIATION 4.3 • n=116 Participants
|
28.2 kg/m^2
STANDARD_DEVIATION 4.3 • n=120 Participants
|
27.8 kg/m^2
STANDARD_DEVIATION 4.6 • n=124 Participants
|
27.9 kg/m^2
STANDARD_DEVIATION 4.0 • n=124 Participants
|
28.0 kg/m^2
STANDARD_DEVIATION 4.3 • n=602 Participants
|
|
Time since first diagnosis of asthma
|
372.3 months
n=118 Participants
|
372.8 months
n=116 Participants
|
373.9 months
n=120 Participants
|
306.6 months
n=124 Participants
|
385.0 months
n=124 Participants
|
363.8 months
n=602 Participants
|
|
Age at first diagnosis of asthma
|
17.4 years
STANDARD_DEVIATION 18.3 • n=118 Participants
|
17.3 years
STANDARD_DEVIATION 18.1 • n=116 Participants
|
17.2 years
STANDARD_DEVIATION 17.7 • n=120 Participants
|
17.4 years
STANDARD_DEVIATION 18.0 • n=124 Participants
|
16.5 years
STANDARD_DEVIATION 15.8 • n=124 Participants
|
17.2 years
STANDARD_DEVIATION 17.6 • n=602 Participants
|
|
Asthma medication category at study entry
Short-Acting β2-agonist (SABA), (albuterol)
|
115 Participants
n=118 Participants
|
115 Participants
n=116 Participants
|
117 Participants
n=120 Participants
|
124 Participants
n=124 Participants
|
121 Participants
n=124 Participants
|
592 Participants
n=602 Participants
|
|
Asthma medication category at study entry
Leukotriene Receptor Antagonist (LTRA)
|
24 Participants
n=118 Participants
|
7 Participants
n=116 Participants
|
17 Participants
n=120 Participants
|
18 Participants
n=124 Participants
|
17 Participants
n=124 Participants
|
83 Participants
n=602 Participants
|
|
Asthma medication category at study entry
Theophylline
|
0 Participants
n=118 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=124 Participants
|
0 Participants
n=124 Participants
|
0 Participants
n=602 Participants
|
|
Asthma medication category at study entry
Inhaled Corticosteroid (ICS) alone
|
23 Participants
n=118 Participants
|
26 Participants
n=116 Participants
|
34 Participants
n=120 Participants
|
36 Participants
n=124 Participants
|
28 Participants
n=124 Participants
|
147 Participants
n=602 Participants
|
|
Asthma medication category at study entry
ICS/ Long-Acting β2-agonist (LABA), (free or fixed combination)
|
93 Participants
n=118 Participants
|
88 Participants
n=116 Participants
|
86 Participants
n=120 Participants
|
88 Participants
n=124 Participants
|
94 Participants
n=124 Participants
|
449 Participants
n=602 Participants
|
|
Asthma medication category at study entry
ICS/Long-Acting Muscarinic Antagonist (LAMA), (free combination)
|
0 Participants
n=118 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=124 Participants
|
0 Participants
n=124 Participants
|
0 Participants
n=602 Participants
|
|
Asthma medication category at study entry
ICS/LABA/LAMA
|
2 Participants
n=118 Participants
|
2 Participants
n=116 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=124 Participants
|
1 Participants
n=124 Participants
|
5 Participants
n=602 Participants
|
|
Asthma medication category at study entry
Short-Acting Muscarinic Antagonist (SAMA)
|
0 Participants
n=118 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=124 Participants
|
1 Participants
n=124 Participants
|
1 Participants
n=602 Participants
|
|
Asthma medication category at study entry
SAMA/SABA
|
0 Participants
n=118 Participants
|
0 Participants
n=116 Participants
|
1 Participants
n=120 Participants
|
0 Participants
n=124 Participants
|
0 Participants
n=124 Participants
|
1 Participants
n=602 Participants
|
|
ICS dose before study
Low daily dose
|
50 Participants
n=118 Participants
|
50 Participants
n=116 Participants
|
48 Participants
n=120 Participants
|
54 Participants
n=124 Participants
|
51 Participants
n=124 Participants
|
253 Participants
n=602 Participants
|
|
ICS dose before study
Medium daily dose
|
68 Participants
n=118 Participants
|
66 Participants
n=116 Participants
|
72 Participants
n=120 Participants
|
70 Participants
n=124 Participants
|
73 Participants
n=124 Participants
|
349 Participants
n=602 Participants
|
|
Smoking habits
Ex-smoker
|
13 Participants
n=118 Participants
|
18 Participants
n=116 Participants
|
18 Participants
n=120 Participants
|
21 Participants
n=124 Participants
|
23 Participants
n=124 Participants
|
93 Participants
n=602 Participants
|
|
Smoking habits
Non-smoker
|
105 Participants
n=118 Participants
|
98 Participants
n=116 Participants
|
102 Participants
n=120 Participants
|
103 Participants
n=124 Participants
|
101 Participants
n=124 Participants
|
509 Participants
n=602 Participants
|
|
Duration of smoking
|
10.3 years
STANDARD_DEVIATION 8.2 • n=13 Participants • Explain why number analyzed in row differs from overall. This was a trial with asthma patients. Only prior smokers were anlayzed for duration of smoking.
|
9.5 years
STANDARD_DEVIATION 6.1 • n=18 Participants • Explain why number analyzed in row differs from overall. This was a trial with asthma patients. Only prior smokers were anlayzed for duration of smoking.
|
13.7 years
STANDARD_DEVIATION 9.1 • n=18 Participants • Explain why number analyzed in row differs from overall. This was a trial with asthma patients. Only prior smokers were anlayzed for duration of smoking.
|
10.4 years
STANDARD_DEVIATION 8.6 • n=21 Participants • Explain why number analyzed in row differs from overall. This was a trial with asthma patients. Only prior smokers were anlayzed for duration of smoking.
|
10.3 years
STANDARD_DEVIATION 6.7 • n=23 Participants • Explain why number analyzed in row differs from overall. This was a trial with asthma patients. Only prior smokers were anlayzed for duration of smoking.
|
10.8 years
STANDARD_DEVIATION 7.7 • n=93 Participants • Explain why number analyzed in row differs from overall. This was a trial with asthma patients. Only prior smokers were anlayzed for duration of smoking.
|
|
Number of pack-years
|
2.0 pack-years
n=13 Participants • Explain why number analyzed in row differs from overall. This was a trial of asthma patients. Pack years are only reported for ex-smokers. For one patients in Arm D, the number of pack years was not reported.
|
2.7 pack-years
n=18 Participants • Explain why number analyzed in row differs from overall. This was a trial of asthma patients. Pack years are only reported for ex-smokers. For one patients in Arm D, the number of pack years was not reported.
|
4.0 pack-years
n=18 Participants • Explain why number analyzed in row differs from overall. This was a trial of asthma patients. Pack years are only reported for ex-smokers. For one patients in Arm D, the number of pack years was not reported.
|
3.5 pack-years
n=20 Participants • Explain why number analyzed in row differs from overall. This was a trial of asthma patients. Pack years are only reported for ex-smokers. For one patients in Arm D, the number of pack years was not reported.
|
3.0 pack-years
n=23 Participants • Explain why number analyzed in row differs from overall. This was a trial of asthma patients. Pack years are only reported for ex-smokers. For one patients in Arm D, the number of pack years was not reported.
|
3.0 pack-years
n=92 Participants • Explain why number analyzed in row differs from overall. This was a trial of asthma patients. Pack years are only reported for ex-smokers. For one patients in Arm D, the number of pack years was not reported.
|
|
FEV1 at baseline
|
2.131 litres
STANDARD_DEVIATION 0.500 • n=118 Participants
|
2.128 litres
STANDARD_DEVIATION 0.545 • n=116 Participants
|
2.114 litres
STANDARD_DEVIATION 0.531 • n=120 Participants
|
2.268 litres
STANDARD_DEVIATION 0.603 • n=124 Participants
|
2.130 litres
STANDARD_DEVIATION 0.571 • n=124 Participants
|
2.155 litres
STANDARD_DEVIATION 0.553 • n=602 Participants
|
|
FEV1 (% predicted normal value) at baseline
|
68.5 percent of predicted normal value
STANDARD_DEVIATION 8.4 • n=118 Participants
|
68.3 percent of predicted normal value
STANDARD_DEVIATION 7.8 • n=116 Participants
|
68.4 percent of predicted normal value
STANDARD_DEVIATION 8.7 • n=120 Participants
|
68.6 percent of predicted normal value
STANDARD_DEVIATION 8.0 • n=124 Participants
|
68.8 percent of predicted normal value
STANDARD_DEVIATION 8.9 • n=124 Participants
|
68.5 percent of predicted normal value
STANDARD_DEVIATION 8.4 • n=602 Participants
|
|
FVC at baseline
|
3.159 litres
STANDARD_DEVIATION 0.971 • n=118 Participants
|
3.164 litres
STANDARD_DEVIATION 0.931 • n=116 Participants
|
3.101 litres
STANDARD_DEVIATION 0.855 • n=120 Participants
|
3.415 litres
STANDARD_DEVIATION 1.020 • n=124 Participants
|
3.197 litres
STANDARD_DEVIATION 0.851 • n=124 Participants
|
3.209 litres
STANDARD_DEVIATION 0.931 • n=602 Participants
|
|
FEV1/FVC at baseline
|
0.696 ratio of the parameters
STANDARD_DEVIATION 0.104 • n=118 Participants
|
0.687 ratio of the parameters
STANDARD_DEVIATION 0.099 • n=116 Participants
|
0.693 ratio of the parameters
STANDARD_DEVIATION 0.098 • n=120 Participants
|
0.677 ratio of the parameters
STANDARD_DEVIATION 0.104 • n=124 Participants
|
0.675 ratio of the parameters
STANDARD_DEVIATION 0.106 • n=124 Participants
|
0.685 ratio of the parameters
STANDARD_DEVIATION 0.102 • n=602 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: Intention to treat: All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline.
Change from baseline in pre-dose morning FEV1 (average of pre-dose FEV1 measurements) at Week 8. Spirometry, used to measure FEV1, was performed according to internationally accepted standards. Definitions: Baseline=Baseline values for pre-dose FEV1 were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FEV1=Forced expiratory volume in the 1st second;
Outcome measures
| Measure |
Treatment A (CHF 718 pMDI 100 µg TDD)
n=117 Participants
CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;
CHF 718 pMDI 50 μg/actuation: 1 inhalation 2 times a day (BID);
|
Treatment B (CHF 718 pMDI 400 µg TDD)
n=115 Participants
CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;
CHF 718 pMDI 100 μg/actuation: 2 inhalations BID;
|
Treatment C (CHF 718 pMDI 800 µg TDD)
n=119 Participants
CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;
CHF 718 pMDI 100 μg/actuation: 4 inhalations BID;
|
Treatment D (Placebo)
n=123 Participants
Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations BID;
|
Treatment E (QVAR^®, 320 µg TDD)
n=124 Participants
Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR\^®), Active Control
Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR® 80 μg/actuation: 2 inhalations BID;
|
|---|---|---|---|---|---|
|
Pre-dose Morning FEV1 at Week 8 - Change From Baseline
|
0.021 Litres
Interval -0.036 to 0.077
|
0.090 Litres
Interval 0.033 to 0.147
|
0.070 Litres
Interval 0.013 to 0.126
|
-0.023 Litres
Interval -0.079 to 0.033
|
0.078 Litres
Interval 0.024 to 0.133
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Intention to treat: All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline.
Change from baseline in pre-dose morning FEV1 at Week 4. Spirometry, used to measure FEV1, was performed according to internationally accepted standards. Definitions: Baseline=Baseline values for pre-dose FEV1 were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FEV1=Forced expiratory volume in the 1st second;
Outcome measures
| Measure |
Treatment A (CHF 718 pMDI 100 µg TDD)
n=117 Participants
CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;
CHF 718 pMDI 50 μg/actuation: 1 inhalation 2 times a day (BID);
|
Treatment B (CHF 718 pMDI 400 µg TDD)
n=115 Participants
CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;
CHF 718 pMDI 100 μg/actuation: 2 inhalations BID;
|
Treatment C (CHF 718 pMDI 800 µg TDD)
n=119 Participants
CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;
CHF 718 pMDI 100 μg/actuation: 4 inhalations BID;
|
Treatment D (Placebo)
n=123 Participants
Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations BID;
|
Treatment E (QVAR^®, 320 µg TDD)
n=124 Participants
Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR\^®), Active Control
Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR® 80 μg/actuation: 2 inhalations BID;
|
|---|---|---|---|---|---|
|
Pre-dose Morning FEV1 at Week 4 - Change From Baseline
|
0.021 Litres
Interval -0.035 to 0.077
|
0.120 Litres
Interval 0.064 to 0.177
|
0.073 Litres
Interval 0.018 to 0.129
|
0.003 Litres
Interval -0.052 to 0.058
|
0.077 Litres
Interval 0.023 to 0.131
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8Population: Intention to treat: All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline.
Change from baseline in pre-dose morning FVC at Week 4 and 8. Spirometry, used to measure FVC, was performed according to internationally accepted standards. Definitions: Baseline=Baseline values for pre-dose FVC were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FVC=Forced vital capacity;
Outcome measures
| Measure |
Treatment A (CHF 718 pMDI 100 µg TDD)
n=117 Participants
CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;
CHF 718 pMDI 50 μg/actuation: 1 inhalation 2 times a day (BID);
|
Treatment B (CHF 718 pMDI 400 µg TDD)
n=115 Participants
CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;
CHF 718 pMDI 100 μg/actuation: 2 inhalations BID;
|
Treatment C (CHF 718 pMDI 800 µg TDD)
n=119 Participants
CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;
CHF 718 pMDI 100 μg/actuation: 4 inhalations BID;
|
Treatment D (Placebo)
n=123 Participants
Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations BID;
|
Treatment E (QVAR^®, 320 µg TDD)
n=124 Participants
Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR\^®), Active Control
Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR® 80 μg/actuation: 2 inhalations BID;
|
|---|---|---|---|---|---|
|
Pre-dose Morning FVC at Week 4 and 8 - Change From Baseline
Week 4
|
0.036 Litres
Interval -0.026 to 0.097
|
0.099 Litres
Interval 0.037 to 0.161
|
0.066 Litres
Interval 0.006 to 0.127
|
0.023 Litres
Interval -0.037 to 0.084
|
0.056 Litres
Interval -0.004 to 0.115
|
|
Pre-dose Morning FVC at Week 4 and 8 - Change From Baseline
Week 8
|
0.014 Litres
Interval -0.053 to 0.08
|
0.089 Litres
Interval 0.022 to 0.156
|
0.036 Litres
Interval -0.03 to 0.103
|
-0.016 Litres
Interval -0.082 to 0.05
|
0.063 Litres
Interval -0.001 to 0.127
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8Population: Intention to treat: All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline.
The ACQ consists of 7 items: 6 simple self-administered questions referring to asthma control and rescue treatment usage with 1 week recall, and a 7th item consisting of the percent (%) predicted FEV1 completed by clinic staff. Scoring uses a 7-point scale: 0 = "totally controlled" and 6 = "severely uncontrolled". The ACQ score was calculated as the average of all 7 items. Definitions: ACQ-7 score=Asthma Control Questionnaire-7©; Information regarding the American Thoracic Society ACQ questionnaire is also available at: https://member.thoracic.org/members/assemblies/assemblies/srn/questionaires/acq.php; Baseline ACQ-7 score = ACQ score recorded at V2 (Week 0) Day 1, before randomization; FEV1=Forced expiratory volume in the 1st second;
Outcome measures
| Measure |
Treatment A (CHF 718 pMDI 100 µg TDD)
n=117 Participants
CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;
CHF 718 pMDI 50 μg/actuation: 1 inhalation 2 times a day (BID);
|
Treatment B (CHF 718 pMDI 400 µg TDD)
n=115 Participants
CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;
CHF 718 pMDI 100 μg/actuation: 2 inhalations BID;
|
Treatment C (CHF 718 pMDI 800 µg TDD)
n=119 Participants
CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;
CHF 718 pMDI 100 μg/actuation: 4 inhalations BID;
|
Treatment D (Placebo)
n=123 Participants
Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations BID;
|
Treatment E (QVAR^®, 320 µg TDD)
n=124 Participants
Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR\^®), Active Control
Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR® 80 μg/actuation: 2 inhalations BID;
|
|---|---|---|---|---|---|
|
Asthma Control Questionnaire-7© (ACQ-7) Score at Week 4 and Week 8 - Change From Baseline
Week 4
|
-0.43 score on a scale
Interval -0.54 to -0.32
|
-0.53 score on a scale
Interval -0.65 to -0.42
|
-0.49 score on a scale
Interval -0.6 to -0.38
|
-0.27 score on a scale
Interval -0.38 to -0.17
|
-0.47 score on a scale
Interval -0.58 to -0.36
|
|
Asthma Control Questionnaire-7© (ACQ-7) Score at Week 4 and Week 8 - Change From Baseline
Week 8
|
-0.53 score on a scale
Interval -0.65 to -0.42
|
-0.58 score on a scale
Interval -0.7 to -0.46
|
-0.66 score on a scale
Interval -0.78 to -0.55
|
-0.43 score on a scale
Interval -0.54 to -0.31
|
-0.64 score on a scale
Interval -0.75 to -0.53
|
SECONDARY outcome
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)Population: Intention to treat: All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline.
Change from baseline in average use of rescue medication, during Inter-visit period 1, Inter-visit period 2, Entire treatment period. Definitions: Baseline=For the efficacy variable -- average use of rescue medication -- derived from the electronic diary (eDiary), baseline values were the averages recorded during the run-in period; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening
Outcome measures
| Measure |
Treatment A (CHF 718 pMDI 100 µg TDD)
n=118 Participants
CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;
CHF 718 pMDI 50 μg/actuation: 1 inhalation 2 times a day (BID);
|
Treatment B (CHF 718 pMDI 400 µg TDD)
n=115 Participants
CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;
CHF 718 pMDI 100 μg/actuation: 2 inhalations BID;
|
Treatment C (CHF 718 pMDI 800 µg TDD)
n=118 Participants
CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;
CHF 718 pMDI 100 μg/actuation: 4 inhalations BID;
|
Treatment D (Placebo)
n=124 Participants
Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations BID;
|
Treatment E (QVAR^®, 320 µg TDD)
n=124 Participants
Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR\^®), Active Control
Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR® 80 μg/actuation: 2 inhalations BID;
|
|---|---|---|---|---|---|
|
Average Use of Rescue Medication - Change From Baseline
Inter-visit period 1
|
-0.11 puffs/day
Interval -0.25 to 0.03
|
-0.27 puffs/day
Interval -0.41 to -0.12
|
-0.14 puffs/day
Interval -0.28 to 0.0
|
0.07 puffs/day
Interval -0.07 to 0.21
|
-0.13 puffs/day
Interval -0.26 to 0.01
|
|
Average Use of Rescue Medication - Change From Baseline
Inter-visit period 2
|
-0.12 puffs/day
Interval -0.29 to 0.05
|
-0.35 puffs/day
Interval -0.52 to -0.18
|
-0.25 puffs/day
Interval -0.42 to -0.08
|
0.01 puffs/day
Interval -0.15 to 0.18
|
-0.18 puffs/day
Interval -0.34 to -0.01
|
|
Average Use of Rescue Medication - Change From Baseline
Entire treatment period
|
-0.11 puffs/day
Interval -0.26 to 0.03
|
-0.31 puffs/day
Interval -0.46 to -0.16
|
-0.20 puffs/day
Interval -0.34 to -0.05
|
0.04 puffs/day
Interval -0.1 to 0.19
|
-0.15 puffs/day
Interval -0.29 to -0.01
|
SECONDARY outcome
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)Population: Intention to treat: All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline.
Change from baseline in percentage (%) of rescue medication-free days. An increased value indicates improvement from baseline. Definitions: Baseline=For the efficacy variable -- percentage (%) of rescue medication-free days -- derived from the electronic diary (eDiary), baseline values were the averages/percentages recorded during the run-in period. Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening
Outcome measures
| Measure |
Treatment A (CHF 718 pMDI 100 µg TDD)
n=118 Participants
CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;
CHF 718 pMDI 50 μg/actuation: 1 inhalation 2 times a day (BID);
|
Treatment B (CHF 718 pMDI 400 µg TDD)
n=115 Participants
CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;
CHF 718 pMDI 100 μg/actuation: 2 inhalations BID;
|
Treatment C (CHF 718 pMDI 800 µg TDD)
n=118 Participants
CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;
CHF 718 pMDI 100 μg/actuation: 4 inhalations BID;
|
Treatment D (Placebo)
n=124 Participants
Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations BID;
|
Treatment E (QVAR^®, 320 µg TDD)
n=124 Participants
Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR\^®), Active Control
Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR® 80 μg/actuation: 2 inhalations BID;
|
|---|---|---|---|---|---|
|
Percentage (%) of Rescue Medication-free Days - Change From Baseline
Inter-visit period 1
|
5.9 % of rescue medication-free days
Interval 1.9 to 9.9
|
9.0 % of rescue medication-free days
Interval 5.0 to 13.0
|
6.1 % of rescue medication-free days
Interval 2.1 to 10.1
|
1.5 % of rescue medication-free days
Interval -2.4 to 5.3
|
7.7 % of rescue medication-free days
Interval 3.9 to 11.6
|
|
Percentage (%) of Rescue Medication-free Days - Change From Baseline
Inter-visit period 2
|
8.9 % of rescue medication-free days
Interval 4.5 to 13.3
|
13.1 % of rescue medication-free days
Interval 8.7 to 17.6
|
10.0 % of rescue medication-free days
Interval 5.6 to 14.4
|
4.1 % of rescue medication-free days
Interval -0.2 to 8.4
|
11.2 % of rescue medication-free days
Interval 7.0 to 15.5
|
|
Percentage (%) of Rescue Medication-free Days - Change From Baseline
Entire treatment period
|
7.4 % of rescue medication-free days
Interval 3.4 to 11.3
|
11.1 % of rescue medication-free days
Interval 7.1 to 15.1
|
8.1 % of rescue medication-free days
Interval 4.1 to 12.0
|
2.8 % of rescue medication-free days
Interval -1.1 to 6.6
|
9.5 % of rescue medication-free days
Interval 5.6 to 13.3
|
SECONDARY outcome
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)Population: Intention to treat: All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline.
Overall daily asthma symptoms scores - Change From Baseline (am and pm). Subjects had to record asthma symptom score (overall symptoms, cough, wheeze, chest tightness and breathlessness) in the am (night-time asthma symptom score) and in the pm (daytime asthma symptom score). These data were collected in the subject's diary. Daily asthma symptoms score were performed separately for am score and pm score and also as a total, where the total equals the sum of the am and pm scores. Degree of asthma symptoms by score: 0=None, 1=Mild, 2=Moderate, and 3=Severe. Baseline=Averages values during the run-in period; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening
Outcome measures
| Measure |
Treatment A (CHF 718 pMDI 100 µg TDD)
n=118 Participants
CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;
CHF 718 pMDI 50 μg/actuation: 1 inhalation 2 times a day (BID);
|
Treatment B (CHF 718 pMDI 400 µg TDD)
n=115 Participants
CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;
CHF 718 pMDI 100 μg/actuation: 2 inhalations BID;
|
Treatment C (CHF 718 pMDI 800 µg TDD)
n=118 Participants
CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;
CHF 718 pMDI 100 μg/actuation: 4 inhalations BID;
|
Treatment D (Placebo)
n=124 Participants
Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations BID;
|
Treatment E (QVAR^®, 320 µg TDD)
n=124 Participants
Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR\^®), Active Control
Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR® 80 μg/actuation: 2 inhalations BID;
|
|---|---|---|---|---|---|
|
Overall Daily Asthma Symptoms Scores - Change From Baseline
Inter-visit period 1
|
-0.1 score on a scale
Interval -0.1 to 0.0
|
-0.1 score on a scale
Interval -0.1 to 0.0
|
-0.1 score on a scale
Interval -0.1 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.1
|
-0.1 score on a scale
Interval -0.2 to -0.1
|
|
Overall Daily Asthma Symptoms Scores - Change From Baseline
Inter-visit period 2
|
-0.1 score on a scale
Interval -0.2 to -0.1
|
-0.1 score on a scale
Interval -0.2 to -0.1
|
-0.1 score on a scale
Interval -0.2 to -0.1
|
-0.0 score on a scale
Interval -0.1 to 0.0
|
-0.1 score on a scale
Interval -0.2 to -0.1
|
|
Overall Daily Asthma Symptoms Scores - Change From Baseline
Entire treatment period
|
-0.1 score on a scale
Interval -0.1 to -0.1
|
-0.1 score on a scale
Interval -0.1 to -0.1
|
-0.1 score on a scale
Interval -0.2 to -0.1
|
0.0 score on a scale
Interval 0.0 to 0.1
|
-0.1 score on a scale
Interval -0.2 to -0.1
|
SECONDARY outcome
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)Population: Intention to treat: All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline.
Change from baseline in Percentage (%) of asthma symptoms-free days. Asthma symptoms-free days is the number of days with a total asthma score=0 (daily morning plus evening asthma score). Subjects recorded asthma symptom score as described in the Outcome measure #7. Definitions: Baseline=For the efficacy variables -- daytime and night-time asthma symptom scores -- derived from the eDiary, baseline values were the averages/percentages recorded during the run-in period; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening
Outcome measures
| Measure |
Treatment A (CHF 718 pMDI 100 µg TDD)
n=118 Participants
CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;
CHF 718 pMDI 50 μg/actuation: 1 inhalation 2 times a day (BID);
|
Treatment B (CHF 718 pMDI 400 µg TDD)
n=115 Participants
CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;
CHF 718 pMDI 100 μg/actuation: 2 inhalations BID;
|
Treatment C (CHF 718 pMDI 800 µg TDD)
n=118 Participants
CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;
CHF 718 pMDI 100 μg/actuation: 4 inhalations BID;
|
Treatment D (Placebo)
n=124 Participants
Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations BID;
|
Treatment E (QVAR^®, 320 µg TDD)
n=124 Participants
Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR\^®), Active Control
Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR® 80 μg/actuation: 2 inhalations BID;
|
|---|---|---|---|---|---|
|
Percentage (%) of Asthma Symptoms-free Days - Change From Baseline
Inter-visit period 1
|
8.6 % of of asthma symptom-free days
Interval 4.5 to 12.7
|
10.5 % of of asthma symptom-free days
Interval 6.4 to 14.7
|
10.1 % of of asthma symptom-free days
Interval 6.0 to 14.2
|
5.7 % of of asthma symptom-free days
Interval 1.6 to 9.7
|
12.8 % of of asthma symptom-free days
Interval 8.8 to 16.8
|
|
Percentage (%) of Asthma Symptoms-free Days - Change From Baseline
Inter-visit period 2
|
16.4 % of of asthma symptom-free days
Interval 11.1 to 21.7
|
17.0 % of of asthma symptom-free days
Interval 11.6 to 22.4
|
17.2 % of of asthma symptom-free days
Interval 11.8 to 22.51
|
11.7 % of of asthma symptom-free days
Interval 6.5 to 16.9
|
21.2 % of of asthma symptom-free days
Interval 16.1 to 26.4
|
|
Percentage (%) of Asthma Symptoms-free Days - Change From Baseline
Entire treatment period
|
12.5 % of of asthma symptom-free days
Interval 8.0 to 17.0
|
13.8 % of of asthma symptom-free days
Interval 9.3 to 18.3
|
13.6 % of of asthma symptom-free days
Interval 9.2 to 18.1
|
8.7 % of of asthma symptom-free days
Interval 4.3 to 13.1
|
17.0 % of of asthma symptom-free days
Interval 12.7 to 21.4
|
SECONDARY outcome
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)Population: Intention to treat: All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline.
Change from baseline in percentage (%) of asthma control days, during Inter-visit period 1, Inter-visit period 2, Entire treatment period. This outcome measure was calculated according to the following definition: Days with a total daily morning + evening asthma score = 0 AND No rescue medication use. Definitions: Baseline=For the efficacy variable -- asthma control days -- derived from the eDiary, baseline values were the averages/percentages recorded during the run-in period; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening
Outcome measures
| Measure |
Treatment A (CHF 718 pMDI 100 µg TDD)
n=118 Participants
CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;
CHF 718 pMDI 50 μg/actuation: 1 inhalation 2 times a day (BID);
|
Treatment B (CHF 718 pMDI 400 µg TDD)
n=115 Participants
CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;
CHF 718 pMDI 100 μg/actuation: 2 inhalations BID;
|
Treatment C (CHF 718 pMDI 800 µg TDD)
n=118 Participants
CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;
CHF 718 pMDI 100 μg/actuation: 4 inhalations BID;
|
Treatment D (Placebo)
n=124 Participants
Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations BID;
|
Treatment E (QVAR^®, 320 µg TDD)
n=124 Participants
Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR\^®), Active Control
Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR® 80 μg/actuation: 2 inhalations BID;
|
|---|---|---|---|---|---|
|
Percentage (%) of Asthma Control Days - Change From Baseline
Inter-visit period 1
|
7.3 % of asthma control days
Interval 3.3 to 11.3
|
10.6 % of asthma control days
Interval 6.5 to 14.6
|
10.4 % of asthma control days
Interval 6.4 to 14.5
|
5.0 % of asthma control days
Interval 1.1 to 9.0
|
12.8 % of asthma control days
Interval 8.8 to 16.7
|
|
Percentage (%) of Asthma Control Days - Change From Baseline
Inter-visit period 2
|
14.3 % of asthma control days
Interval 9.1 to 19.5
|
16.3 % of asthma control days
Interval 11.0 to 21.5
|
17.5 % of asthma control days
Interval 12.2 to 22.7
|
10.5 % of asthma control days
Interval 5.3 to 15.6
|
20.63 % of asthma control days
Interval 15.6 to 25.7
|
|
Percentage (%) of Asthma Control Days - Change From Baseline
Entire treatment period
|
10.8 % of asthma control days
Interval 6.4 to 15.2
|
13.4 % of asthma control days
Interval 9.0 to 17.9
|
13.9 % of asthma control days
Interval 9.5 to 18.3
|
7.7 % of asthma control days
Interval 3.4 to 12.1
|
16.7 % of asthma control days
Interval 12.4 to 21.0
|
SECONDARY outcome
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)Population: Intention to treat: All randomized patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline (primary or secondary efficacy variables) after the baseline.
Change from baseline in pre-dose Peak Expiratory Flow (PEF) (Liters/min), morning and evening measurements. Definitions: Baseline=For the efficacy variable -- morning and evening PEF -- derived from the eDiary, the baseline values were the averages/percentages recorded during the run-in period; PEF=evening peak expiratory flow; Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4); Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8); Entire treatment period=Average of 8 weeks; am=morning pm=evening
Outcome measures
| Measure |
Treatment A (CHF 718 pMDI 100 µg TDD)
n=116 Participants
CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;
CHF 718 pMDI 50 μg/actuation: 1 inhalation 2 times a day (BID);
|
Treatment B (CHF 718 pMDI 400 µg TDD)
n=114 Participants
CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;
CHF 718 pMDI 100 μg/actuation: 2 inhalations BID;
|
Treatment C (CHF 718 pMDI 800 µg TDD)
n=115 Participants
CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;
CHF 718 pMDI 100 μg/actuation: 4 inhalations BID;
|
Treatment D (Placebo)
n=121 Participants
Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations BID;
|
Treatment E (QVAR^®, 320 µg TDD)
n=119 Participants
Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR\^®), Active Control
Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR® 80 μg/actuation: 2 inhalations BID;
|
|---|---|---|---|---|---|
|
Pre-dose Peak Expiratory Flow (PEF) (L/Min) (Morning and Evening) - Change From Baseline
Inter-visit period 1
|
-2 Liters/min
Interval -7.1 to 3.7
|
-3 Liters/min
Interval -8.1 to 2.73
|
-4 Liters/min
Interval -9.3 to 1.5
|
-6 Liters/min
Interval -11.3 to -0.8
|
0 Liters/min
Interval -5.0 to 5.6
|
|
Pre-dose Peak Expiratory Flow (PEF) (L/Min) (Morning and Evening) - Change From Baseline
Inter-visit period 2
|
-4 Liters/min
Interval -10.9 to 2.3
|
3 Liters/min
Interval -3.3 to 10.0
|
-5 Liters/min
Interval -11.7 to 1.6
|
-4 Liters/min
Interval -10.3 to 2.8
|
2 Liters/min
Interval -4.2 to 8.8
|
|
Pre-dose Peak Expiratory Flow (PEF) (L/Min) (Morning and Evening) - Change From Baseline
Entire treatment period
|
-3 Liters/min
Interval -8.6 to 2.6
|
0.3 Liters/min
Interval -5.3 to 6.0
|
-4 Liters/min
Interval -10.0 to 1.1
|
-4.9 Liters/min
Interval -10.4 to 0.6
|
1 Liters/min
Interval -4.2 to 6.8
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8Population: Safety population: All randomized patients who received at least one dose of study treatment.
Vital signs (systolic and diastolic blood pressure) at baseline, week 4, and week 8. Change from baseline. Definitions: Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose; DBP=Diastolic blood pressure; SBP=Systolic blood pressure;
Outcome measures
| Measure |
Treatment A (CHF 718 pMDI 100 µg TDD)
n=117 Participants
CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;
CHF 718 pMDI 50 μg/actuation: 1 inhalation 2 times a day (BID);
|
Treatment B (CHF 718 pMDI 400 µg TDD)
n=115 Participants
CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;
CHF 718 pMDI 100 μg/actuation: 2 inhalations BID;
|
Treatment C (CHF 718 pMDI 800 µg TDD)
n=119 Participants
CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;
CHF 718 pMDI 100 μg/actuation: 4 inhalations BID;
|
Treatment D (Placebo)
n=124 Participants
Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations BID;
|
Treatment E (QVAR^®, 320 µg TDD)
n=124 Participants
Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR\^®), Active Control
Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR® 80 μg/actuation: 2 inhalations BID;
|
|---|---|---|---|---|---|
|
Vital Signs (Systolic and Diastolic Blood Pressure) - Change From Baseline
SBP, Week 4
|
-0.4 mmHg
Interval -39.0 to 30.0
|
1.0 mmHg
Interval -18.0 to 27.0
|
0.5 mmHg
Interval -25.0 to 24.0
|
0.6 mmHg
Interval -24.0 to 27.0
|
0.0 mmHg
Interval -20.0 to 30.0
|
|
Vital Signs (Systolic and Diastolic Blood Pressure) - Change From Baseline
SBP, Week 8
|
1.0 mmHg
Interval -23.0 to 30.0
|
2.5 mmHg
Interval -24.0 to 24.0
|
0.8 mmHg
Interval -32.0 to 33.0
|
0.2 mmHg
Interval -21.0 to 34.0
|
-0.9 mmHg
Interval -23.0 to 22.0
|
|
Vital Signs (Systolic and Diastolic Blood Pressure) - Change From Baseline
DBP, Week 4
|
-0.1 mmHg
Interval -19.0 to 20.0
|
0.2 mmHg
Interval -16.0 to 28.0
|
-0.8 mmHg
Interval -24.0 to 17.0
|
0.1 mmHg
Interval -15.0 to 18.0
|
0.8 mmHg
Interval -16.0 to 36.0
|
|
Vital Signs (Systolic and Diastolic Blood Pressure) - Change From Baseline
DBP, Week 8
|
0.8 mmHg
Interval -12.0 to 27.0
|
1.0 mmHg
Interval -20.0 to 21.0
|
0.3 mmHg
Interval -21.0 to 21.0
|
-0.5 mmHg
Interval -17.0 to 20.0
|
1.2 mmHg
Interval -20.0 to 21.0
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Safety population: All randomized patients who received at least one dose of study treatment.
12-lead electrocardiogram (12-lead ECG) parameter - heart rate (HR) was measured at baseline (Day 1) and Week 8. Change from baseline. Definitions: Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose; bpm=Beats per minute;
Outcome measures
| Measure |
Treatment A (CHF 718 pMDI 100 µg TDD)
n=116 Participants
CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;
CHF 718 pMDI 50 μg/actuation: 1 inhalation 2 times a day (BID);
|
Treatment B (CHF 718 pMDI 400 µg TDD)
n=115 Participants
CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;
CHF 718 pMDI 100 μg/actuation: 2 inhalations BID;
|
Treatment C (CHF 718 pMDI 800 µg TDD)
n=116 Participants
CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;
CHF 718 pMDI 100 μg/actuation: 4 inhalations BID;
|
Treatment D (Placebo)
n=121 Participants
Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations BID;
|
Treatment E (QVAR^®, 320 µg TDD)
n=122 Participants
Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR\^®), Active Control
Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR® 80 μg/actuation: 2 inhalations BID;
|
|---|---|---|---|---|---|
|
12-lead ECG Parameters - Heart Rate - Change From Baseline
|
0.6 bpm
Interval -28.0 to 24.0
|
0.2 bpm
Interval -25.0 to 22.0
|
0.4 bpm
Interval -27.0 to 29.0
|
1.2 bpm
Interval -22.0 to 39.0
|
-0.4 bpm
Interval -23.0 to 22.0
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Safety population: All randomized patients who received at least one dose of study treatment.
12-lead electrocardiogram (12-lead ECG) parameters - PR, QRS, QTcF intervals - were measured at baseline (Day 1) and Week 8. Changes from baseline. Definitions: Baseline=Baseline values were defined at visit 2 (Week 0); QTcF=Fridericia-corrected QT interval; msec=Millisecond;
Outcome measures
| Measure |
Treatment A (CHF 718 pMDI 100 µg TDD)
n=119 Participants
CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;
CHF 718 pMDI 50 μg/actuation: 1 inhalation 2 times a day (BID);
|
Treatment B (CHF 718 pMDI 400 µg TDD)
n=120 Participants
CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;
CHF 718 pMDI 100 μg/actuation: 2 inhalations BID;
|
Treatment C (CHF 718 pMDI 800 µg TDD)
n=121 Participants
CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;
CHF 718 pMDI 100 μg/actuation: 4 inhalations BID;
|
Treatment D (Placebo)
n=124 Participants
Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations BID;
|
Treatment E (QVAR^®, 320 µg TDD)
n=124 Participants
Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR\^®), Active Control
Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR® 80 μg/actuation: 2 inhalations BID;
|
|---|---|---|---|---|---|
|
12-lead ECG Parameters - PR, QRS, QTcF - Change From Baseline.
PR
|
-2.6 msec
Interval -39.0 to 34.0
|
1.5 msec
Interval -38.0 to 31.0
|
-1.9 msec
Interval -32.0 to 54.0
|
-1.3 msec
Interval -50.0 to 28.0
|
1.0 msec
Interval -43.0 to 71.0
|
|
12-lead ECG Parameters - PR, QRS, QTcF - Change From Baseline.
QRS
|
0.1 msec
Interval -48.0 to 42.0
|
-1.3 msec
Interval -38.0 to 25.0
|
0.9 msec
Interval -29.0 to 26.0
|
-0.5 msec
Interval -30.0 to 21.0
|
-0.3 msec
Interval -48.0 to 25.0
|
|
12-lead ECG Parameters - PR, QRS, QTcF - Change From Baseline.
QTcF
|
1.6 msec
Interval -56.0 to 65.0
|
0.7 msec
Interval -32.0 to 126.0
|
0.7 msec
Interval -37.0 to 45.0
|
4.6 msec
Interval -73.0 to 105.0
|
1.2 msec
Interval -32.0 to 91.0
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Safety population: All randomized patients who received at least one dose of study treatment.
Number of participants with prolonged QTcF. Change from baseline. Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose; QTcF=Fridericia-corrected QT interval;
Outcome measures
| Measure |
Treatment A (CHF 718 pMDI 100 µg TDD)
n=119 Participants
CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;
CHF 718 pMDI 50 μg/actuation: 1 inhalation 2 times a day (BID);
|
Treatment B (CHF 718 pMDI 400 µg TDD)
n=120 Participants
CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;
CHF 718 pMDI 100 μg/actuation: 2 inhalations BID;
|
Treatment C (CHF 718 pMDI 800 µg TDD)
n=121 Participants
CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;
CHF 718 pMDI 100 μg/actuation: 4 inhalations BID;
|
Treatment D (Placebo)
n=124 Participants
Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations BID;
|
Treatment E (QVAR^®, 320 µg TDD)
n=124 Participants
Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR\^®), Active Control
Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR® 80 μg/actuation: 2 inhalations BID;
|
|---|---|---|---|---|---|
|
12-lead ECG Parameters - Prolonged QTcF - Change From Baseline
QTcF > 30 msec
|
6 Participants
|
4 Participants
|
4 Participants
|
9 Participants
|
3 Participants
|
|
12-lead ECG Parameters - Prolonged QTcF - Change From Baseline
QTcF > 60 msec
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Safety population: All randomized patients who received at least one dose of study treatment.
24-hr Urinary Free Cortisol - Change From Baseline. For the evaluation of the 24-hr Urine-Free cortisol excretion, 24-hour urine samples were collected. Urine-free cortisol was measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Definitions: Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose;
Outcome measures
| Measure |
Treatment A (CHF 718 pMDI 100 µg TDD)
n=99 Participants
CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;
CHF 718 pMDI 50 μg/actuation: 1 inhalation 2 times a day (BID);
|
Treatment B (CHF 718 pMDI 400 µg TDD)
n=108 Participants
CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;
CHF 718 pMDI 100 μg/actuation: 2 inhalations BID;
|
Treatment C (CHF 718 pMDI 800 µg TDD)
n=99 Participants
CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;
CHF 718 pMDI 100 μg/actuation: 4 inhalations BID;
|
Treatment D (Placebo)
n=103 Participants
Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations BID;
|
Treatment E (QVAR^®, 320 µg TDD)
n=111 Participants
Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR\^®), Active Control
Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR® 80 μg/actuation: 2 inhalations BID;
|
|---|---|---|---|---|---|
|
24-hr Urine Free Cortisol - Change From Baseline
|
-3.60 nmol/day
Interval -175.8 to 6492.9
|
-5.35 nmol/day
Interval -249.5 to 299.5
|
-4.10 nmol/day
Interval -285.1 to 430.3
|
1.40 nmol/day
Interval -1319.9 to 459.2
|
-3.50 nmol/day
Interval -692.2 to 145.5
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Safety population: All randomized patients who received at least one dose of study treatment.
24-hr Creatinine - Change From Baseline. For the evaluation of the 24-hr creatinine excretion, 24-hour urine sample were collected. Creatinine was measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Definitions: Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose;
Outcome measures
| Measure |
Treatment A (CHF 718 pMDI 100 µg TDD)
n=101 Participants
CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;
CHF 718 pMDI 50 μg/actuation: 1 inhalation 2 times a day (BID);
|
Treatment B (CHF 718 pMDI 400 µg TDD)
n=110 Participants
CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;
CHF 718 pMDI 100 μg/actuation: 2 inhalations BID;
|
Treatment C (CHF 718 pMDI 800 µg TDD)
n=104 Participants
CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;
CHF 718 pMDI 100 μg/actuation: 4 inhalations BID;
|
Treatment D (Placebo)
n=107 Participants
Placebo Control. CHF 718 pMDI matched Placebo: 4 inhalations BID;
|
Treatment E (QVAR^®, 320 µg TDD)
n=111 Participants
Beclomethasone dipropionate hydrofluoroalkane (HFA) (QVAR\^®), Active Control
Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR® 80 μg/actuation: 2 inhalations BID;
|
|---|---|---|---|---|---|
|
24-hr Creatinine - Change From Baseline.
|
0.00 umol/mol
Interval -0.7 to 0.8
|
0.00 umol/mol
Interval -0.7 to 0.5
|
0.00 umol/mol
Interval -0.7 to 0.5
|
0.00 umol/mol
Interval -0.7 to 0.5
|
0.00 umol/mol
Interval -1.0 to 0.7
|
Adverse Events
Treatment A (CHF 718 pMDI 100 µg TDD)
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Treatment B (CHF 718 pMDI 400 µg TDD)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 1 deaths
Treatment C (CHF 718 pMDI 800 µg TDD)
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Treatment D (Placebo)
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Treatment E (QVAR^®, 320 µg TDD)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment A (CHF 718 pMDI 100 µg TDD)
n=119 participants at risk
CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;
CHF 718 pMDI 50 μg/actuation: 1 inhalation twice daily (BID);
|
Treatment B (CHF 718 pMDI 400 µg TDD)
n=120 participants at risk
CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;
CHF 718 pMDI 100 μg/actuation: 2 inhalations BID;
|
Treatment C (CHF 718 pMDI 800 µg TDD)
n=121 participants at risk
CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;
CHF 718 pMDI 100 μg/actuation: 4 inhalations BID;
|
Treatment D (Placebo)
n=124 participants at risk
Placebo Control, Placebo; CHF 718 pMDI matched Placebo: 4 inhalations BID;
|
Treatment E (QVAR^®, 320 µg TDD)
n=124 participants at risk
QVAR\^®, : Active Control
Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg;
QVAR® 80 μg/actuation: 2 inhalations BID;
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/119 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.83%
1/120 • Number of events 1 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/121 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/124 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/124 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.84%
1/119 • Number of events 1 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/120 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/121 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/124 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/124 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/119 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/120 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.83%
1/121 • Number of events 1 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/124 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/124 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
|
Eye disorders
Diplopia
|
0.00%
0/119 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.83%
1/120 • Number of events 1 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/121 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/124 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/124 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/119 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/120 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/121 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.81%
1/124 • Number of events 1 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/124 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/119 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.83%
1/120 • Number of events 1 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/121 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/124 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/124 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
|
Infections and infestations
Furuncle
|
0.00%
0/119 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/120 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.83%
1/121 • Number of events 1 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/124 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/124 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
|
General disorders
Chest pain
|
0.00%
0/119 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.83%
1/120 • Number of events 1 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/121 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/124 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/124 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/119 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/120 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.83%
1/121 • Number of events 1 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/124 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/124 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
Other adverse events
| Measure |
Treatment A (CHF 718 pMDI 100 µg TDD)
n=119 participants at risk
CHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1;
CHF 718 pMDI 50 μg/actuation: 1 inhalation twice daily (BID);
|
Treatment B (CHF 718 pMDI 400 µg TDD)
n=120 participants at risk
CHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2;
CHF 718 pMDI 100 μg/actuation: 2 inhalations BID;
|
Treatment C (CHF 718 pMDI 800 µg TDD)
n=121 participants at risk
CHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3;
CHF 718 pMDI 100 μg/actuation: 4 inhalations BID;
|
Treatment D (Placebo)
n=124 participants at risk
Placebo Control, Placebo; CHF 718 pMDI matched Placebo: 4 inhalations BID;
|
Treatment E (QVAR^®, 320 µg TDD)
n=124 participants at risk
QVAR\^®, : Active Control
Beclomethasone dipropionate hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg;
QVAR® 80 μg/actuation: 2 inhalations BID;
|
|---|---|---|---|---|---|
|
Infections and infestations
Oral candidiasis
|
0.84%
1/119 • Number of events 1 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/120 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
5.0%
6/121 • Number of events 6 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/124 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
3.2%
4/124 • Number of events 4 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
6/119 • Number of events 6 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
1.7%
2/120 • Number of events 2 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
2.5%
3/121 • Number of events 3 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
2.4%
3/124 • Number of events 3 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
5.6%
7/124 • Number of events 7 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.0%
6/119 • Number of events 6 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.83%
1/120 • Number of events 1 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
5.8%
7/121 • Number of events 7 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
4.8%
6/124 • Number of events 6 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
2.4%
3/124 • Number of events 3 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.4%
4/119 • Number of events 4 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
2.5%
3/120 • Number of events 3 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
4.1%
5/121 • Number of events 5 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
8.9%
11/124 • Number of events 11 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
4.0%
5/124 • Number of events 5 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/119 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
1.7%
2/120 • Number of events 2 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
1.7%
2/121 • Number of events 2 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
3.2%
4/124 • Number of events 4 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.81%
1/124 • Number of events 1 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.84%
1/119 • Number of events 1 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.00%
0/120 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
1.7%
2/121 • Number of events 2 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
3.2%
4/124 • Number of events 4 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
0.81%
1/124 • Number of events 1 • From the first intake of study medication (visit 2, Week 0) until study completion (Visit 4, week 8) or discontinuation from the study.
The safety population was used for the evaluation of adverse event (AEs). Safety population=All randomized patients who received at least one dose of study treatment. The overall number of randomized participants in the study=610 (Participant Flow). Nevertheless, the Safety population=608 patients; 2 patients (1 in Group A and 1 in Group C) were excluded because they were mistakenly randomized; they failed to meet inclusion criterion #4 and were withdrawn prior to study drug administration.
|
Additional Information
Clinical Trial Transparency
Chiesi Farmaceutici S.p.A.
Phone: + 39 0521 2791
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Chiesi can publish and/or present any results of this study at scientific meetings, and to submit the clinical trial data to national and international Regulatory Authorities. Chiesi reserves the right to use such data for industrial purposes. Investigators will inform Chiesi before using the results of the study for publication or presentation, and agree to provide the Sponsor with a copy of the proposed presentation. Data from individual study sites must not be published separately.
- Publication restrictions are in place
Restriction type: OTHER