Trial Outcomes & Findings for Efficacy and Safety Study of FP MDPI Compared With FS MDPI in Adolescent and Adult Patients With Persistent Asthma (NCT NCT02141854)
NCT ID: NCT02141854
Last Updated: 2021-11-09
Results Overview
A subset of patients performed postdose serial spirometry. Data from these assessments were used to analyze the primary endpoint of baseline-adjusted FEV1 AUEC0-12h at week 12 using the trapezoidal rule based on actual time of measurement. It was standardized by dividing it by the number of hours between the start time of dose administration and the end time of the last nonmissing FEV1 measurement. The baseline FEV1 was the average of the 2 predose FEV1 measurements (30 and 10 minutes predose). If 1 of these was missing, the nonmissing value was used; if both were missing, baseline was treated as missing. Baseline-adjusted FEV1 was calculated as postdose FEV1 after subtracting the baseline FEV1 value.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
882 participants
Primary outcome timeframe
Day 1 (predose, baseline), Week 12 and was performed at the following times relative to the administration of study drug (±5 minutes): 15 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, and 12 hours
Results posted on
2021-11-09
Participant Flow
A total of 1661 patients with persistent asthma were screened and 882 patients enrolled. 154 patients were not randomized, most commonly (76 patients) because of not meeting randomization criteria.
Participant milestones
| Measure |
Fluticasone Propionate 50 mcg BID
All enrolled participants used single-blind fluticasone propionate multidose dry powder inhaler twice a day for a total daily dose of 100 mcg during the Run-In Period (14-21 days).
|
FS MDPI 200 / 12.5 mcg
Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 100 / 12.5 mcg
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 200 mcg
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 100 mcg
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Placebo MDPI
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
|---|---|---|---|---|---|---|
|
Run-In Period (Pre-assignment)
STARTED
|
882
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
COMPLETED
|
728
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
NOT COMPLETED
|
154
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
STARTED
|
0
|
146
|
145
|
146
|
146
|
145
|
|
Treatment Period
Intent to Treat Population
|
0
|
146
|
145
|
146
|
146
|
145
|
|
Treatment Period
Safety Population
|
0
|
145
|
143
|
146
|
145
|
144
|
|
Treatment Period
Full Analysis Set
|
0
|
145
|
141
|
146
|
145
|
143
|
|
Treatment Period
COMPLETED
|
0
|
136
|
136
|
135
|
136
|
107
|
|
Treatment Period
NOT COMPLETED
|
0
|
10
|
9
|
11
|
10
|
38
|
Reasons for withdrawal
| Measure |
Fluticasone Propionate 50 mcg BID
All enrolled participants used single-blind fluticasone propionate multidose dry powder inhaler twice a day for a total daily dose of 100 mcg during the Run-In Period (14-21 days).
|
FS MDPI 200 / 12.5 mcg
Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 100 / 12.5 mcg
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 200 mcg
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 100 mcg
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Placebo MDPI
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
|---|---|---|---|---|---|---|
|
Run-In Period (Pre-assignment)
Inclusion criteria not met
|
25
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
Randomization criteria not met
|
76
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
Exclusion criteria met
|
14
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
Other
|
14
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
Adverse Event
|
10
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
Withdrawal by Subject
|
9
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
Lost to Follow-up
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
Protocol Violation
|
0
|
1
|
0
|
2
|
2
|
1
|
|
Treatment Period
Noncompliance
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period
Lack of Efficacy
|
0
|
0
|
0
|
1
|
1
|
7
|
|
Treatment Period
Pregnancy
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period
Other
|
0
|
1
|
2
|
0
|
1
|
2
|
|
Treatment Period
Adverse Event
|
0
|
2
|
2
|
0
|
2
|
2
|
|
Treatment Period
Withdrawal by Subject
|
0
|
2
|
3
|
3
|
4
|
7
|
|
Treatment Period
Disease progression
|
0
|
2
|
1
|
3
|
0
|
18
|
|
Treatment Period
Lost to Follow-up
|
0
|
1
|
1
|
1
|
0
|
1
|
Baseline Characteristics
Some participants were missing baseline values
Baseline characteristics by cohort
| Measure |
FS MDPI 200 / 12.5 mcg
n=146 Participants
Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 100 / 12.5 mcg
n=145 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 200 mcg
n=146 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 100 mcg
n=146 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Placebo MDPI
n=145 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Total
n=728 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 16.93 • n=146 Participants
|
44.3 years
STANDARD_DEVIATION 14.88 • n=145 Participants
|
44.4 years
STANDARD_DEVIATION 16.36 • n=146 Participants
|
45.7 years
STANDARD_DEVIATION 15.64 • n=146 Participants
|
44.5 years
STANDARD_DEVIATION 16.05 • n=145 Participants
|
44.7 years
STANDARD_DEVIATION 15.95 • n=728 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
12 Participants
n=146 Participants
|
8 Participants
n=145 Participants
|
10 Participants
n=146 Participants
|
9 Participants
n=146 Participants
|
6 Participants
n=145 Participants
|
45 Participants
n=728 Participants
|
|
Age, Customized
Adults (18-64 years)
|
115 Participants
n=146 Participants
|
125 Participants
n=145 Participants
|
119 Participants
n=146 Participants
|
124 Participants
n=146 Participants
|
125 Participants
n=145 Participants
|
608 Participants
n=728 Participants
|
|
Age, Customized
Adults (65-84 years)
|
19 Participants
n=146 Participants
|
12 Participants
n=145 Participants
|
17 Participants
n=146 Participants
|
13 Participants
n=146 Participants
|
14 Participants
n=145 Participants
|
75 Participants
n=728 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=146 Participants
|
79 Participants
n=145 Participants
|
88 Participants
n=146 Participants
|
94 Participants
n=146 Participants
|
91 Participants
n=145 Participants
|
439 Participants
n=728 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=146 Participants
|
66 Participants
n=145 Participants
|
58 Participants
n=146 Participants
|
52 Participants
n=146 Participants
|
54 Participants
n=145 Participants
|
289 Participants
n=728 Participants
|
|
Race/Ethnicity, Customized
White
|
125 Participants
n=146 Participants
|
112 Participants
n=145 Participants
|
116 Participants
n=146 Participants
|
111 Participants
n=146 Participants
|
124 Participants
n=145 Participants
|
588 Participants
n=728 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
20 Participants
n=146 Participants
|
28 Participants
n=145 Participants
|
23 Participants
n=146 Participants
|
31 Participants
n=146 Participants
|
18 Participants
n=145 Participants
|
120 Participants
n=728 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=146 Participants
|
0 Participants
n=145 Participants
|
2 Participants
n=146 Participants
|
0 Participants
n=146 Participants
|
2 Participants
n=145 Participants
|
4 Participants
n=728 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=146 Participants
|
0 Participants
n=145 Participants
|
2 Participants
n=146 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=145 Participants
|
2 Participants
n=728 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=146 Participants
|
0 Participants
n=145 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=145 Participants
|
0 Participants
n=728 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=146 Participants
|
5 Participants
n=145 Participants
|
3 Participants
n=146 Participants
|
4 Participants
n=146 Participants
|
1 Participants
n=145 Participants
|
14 Participants
n=728 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
136 Participants
n=146 Participants
|
135 Participants
n=145 Participants
|
136 Participants
n=146 Participants
|
134 Participants
n=146 Participants
|
136 Participants
n=145 Participants
|
677 Participants
n=728 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
10 Participants
n=146 Participants
|
10 Participants
n=145 Participants
|
10 Participants
n=146 Participants
|
11 Participants
n=146 Participants
|
8 Participants
n=145 Participants
|
49 Participants
n=728 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=146 Participants
|
0 Participants
n=145 Participants
|
0 Participants
n=146 Participants
|
1 Participants
n=146 Participants
|
1 Participants
n=145 Participants
|
2 Participants
n=728 Participants
|
|
History of Smoking
Prior Smoker
|
20 Participants
n=146 Participants
|
28 Participants
n=145 Participants
|
21 Participants
n=146 Participants
|
28 Participants
n=146 Participants
|
23 Participants
n=145 Participants
|
120 Participants
n=728 Participants
|
|
History of Smoking
No tobacco use
|
126 Participants
n=146 Participants
|
117 Participants
n=145 Participants
|
125 Participants
n=146 Participants
|
118 Participants
n=146 Participants
|
122 Participants
n=145 Participants
|
608 Participants
n=728 Participants
|
|
Previous Asthma Therapy
Inhaled corticosteroid
|
73 Participants
n=146 Participants
|
67 Participants
n=145 Participants
|
63 Participants
n=146 Participants
|
58 Participants
n=146 Participants
|
68 Participants
n=145 Participants
|
329 Participants
n=728 Participants
|
|
Previous Asthma Therapy
Inhaled corticosteroid/long-acting beta2-agonist
|
73 Participants
n=146 Participants
|
78 Participants
n=145 Participants
|
83 Participants
n=146 Participants
|
88 Participants
n=146 Participants
|
77 Participants
n=145 Participants
|
399 Participants
n=728 Participants
|
|
Body Mass Index
|
29.4 kg/m^2
STANDARD_DEVIATION 7.35 • n=146 Participants
|
30.2 kg/m^2
STANDARD_DEVIATION 7.60 • n=145 Participants
|
29.9 kg/m^2
STANDARD_DEVIATION 7.27 • n=146 Participants
|
29.9 kg/m^2
STANDARD_DEVIATION 7.62 • n=146 Participants
|
29.3 kg/m^2
STANDARD_DEVIATION 7.41 • n=145 Participants
|
29.7 kg/m^2
STANDARD_DEVIATION 7.44 • n=728 Participants
|
|
Forced Expiratory Volume in 1 second (FEV1)
|
2.083 liters
STANDARD_DEVIATION 0.6532 • n=145 Participants • Some participants were missing baseline values
|
2.157 liters
STANDARD_DEVIATION 0.6402 • n=142 Participants • Some participants were missing baseline values
|
2.075 liters
STANDARD_DEVIATION 0.5696 • n=146 Participants • Some participants were missing baseline values
|
2.069 liters
STANDARD_DEVIATION 0.6017 • n=145 Participants • Some participants were missing baseline values
|
2.141 liters
STANDARD_DEVIATION 0.6849 • n=144 Participants • Some participants were missing baseline values
|
2.105 liters
STANDARD_DEVIATION 0.6303 • n=722 Participants • Some participants were missing baseline values
|
PRIMARY outcome
Timeframe: Day 1 (predose, baseline), Week 12 and was performed at the following times relative to the administration of study drug (±5 minutes): 15 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, and 12 hoursPopulation: A subset of patients who performed postdose serial spirometry at the baseline visit and week 12.
A subset of patients performed postdose serial spirometry. Data from these assessments were used to analyze the primary endpoint of baseline-adjusted FEV1 AUEC0-12h at week 12 using the trapezoidal rule based on actual time of measurement. It was standardized by dividing it by the number of hours between the start time of dose administration and the end time of the last nonmissing FEV1 measurement. The baseline FEV1 was the average of the 2 predose FEV1 measurements (30 and 10 minutes predose). If 1 of these was missing, the nonmissing value was used; if both were missing, baseline was treated as missing. Baseline-adjusted FEV1 was calculated as postdose FEV1 after subtracting the baseline FEV1 value.
Outcome measures
| Measure |
FS MDPI 200 / 12.5 mcg
n=68 Participants
Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 100 / 12.5 mcg
n=58 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 200 mcg
n=61 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 100 mcg
n=64 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Placebo MDPI
n=61 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
|---|---|---|---|---|---|
|
Standardized Baseline-Adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time Zero to 12 Hours PostDose (FEV1 AUEC0-12) at Week 12
|
0.446 liters
Standard Error 0.0463
|
0.442 liters
Standard Error 0.0496
|
0.267 liters
Standard Error 0.0466
|
0.260 liters
Standard Error 0.0463
|
0.121 liters
Standard Error 0.0472
|
PRIMARY outcome
Timeframe: Day 1 (predose, baseline), Week 12Population: If the patient inadvertently administered asthma medication/study drug at home on the AM of the visit, or if the patient took rescue medication within 6 hours of testing, the visit was rescheduled.
Trough FEV1 is a morning spirometry taken predose and pre-rescue bronchodilator. The baseline for predose FEV1 was defined as the average of the 30-minute and 10-minute predose measurements obtained at the randomization visit (Day 1).
Outcome measures
| Measure |
FS MDPI 200 / 12.5 mcg
n=143 Participants
Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 100 / 12.5 mcg
n=140 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 200 mcg
n=145 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 100 mcg
n=144 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Placebo MDPI
n=143 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
|---|---|---|---|---|---|
|
Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12
|
0.272 liters
Standard Error 0.0307
|
0.271 liters
Standard Error 0.0311
|
0.179 liters
Standard Error 0.0308
|
0.119 liters
Standard Error 0.0311
|
-0.004 liters
Standard Error 0.0312
|
SECONDARY outcome
Timeframe: Days -6 to Day 1 (predose, baseline), Day 1 (postdose) daily until Week 12Population: Full analysis set
Morning PEF tests were performed before administration of study drug or rescue medications (data were excluded if the time of PEF measurement was more than 5 minutes after the dose time). The patient recorded the highest value of 3 measurements obtained in the patient diary. The baseline PEF was the average value of recorded (nonmissing) morning assessments over the 7 days prior to randomization on Day 1. For efficacy analyses of weekly average morning PEF measurements, values were the averages based on available data for that week.
Outcome measures
| Measure |
FS MDPI 200 / 12.5 mcg
n=145 Participants
Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 100 / 12.5 mcg
n=141 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 200 mcg
n=146 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 100 mcg
n=145 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Placebo MDPI
n=142 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Weekly Average of the Daily Morning Trough Peak Expiratory Flow (PEF) Over the 12 Week Treatment
|
20.235 liters/minute
Standard Error 2.3845
|
18.610 liters/minute
Standard Error 2.4137
|
7.464 liters/minute
Standard Error 2.3887
|
5.731 liters/minute
Standard Error 2.4102
|
-10.987 liters/minute
Standard Error 2.4784
|
SECONDARY outcome
Timeframe: Days -6 to Day 1 (predose, baseline), to Week 12Population: Full analysis set
The total daily asthma symptom score is the average of the daytime and nighttime scores as recorded in the patient diary. Daytime Symptom Score: * 0=No symptoms * 1=Symptoms for 1 short period * 2=Symptoms for 2+ short periods * 3=Symptoms for most of the day - did not affect normal daily activities * 4=Symptoms for most of the day - did affect normal daily activities * 5=Symptoms so severe that I could not go to work or perform normal daily activities Nighttime Symptom Score (determined in the AM): * 0=No symptoms * 1=Symptoms causing me to wake once (or wake early) * 2=Symptoms causing me to wake twice or more (including waking early) * 3=Symptoms causing me to be awake for most of the night * 4=Symptoms so severe that I did not sleep Baseline was the average of recorded scores over the 7 days before randomization. The change from baseline in the weekly average over weeks 1 to 12 was analyzed using an mixed model for repeated measures (MMRM).
Outcome measures
| Measure |
FS MDPI 200 / 12.5 mcg
n=145 Participants
Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 100 / 12.5 mcg
n=141 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 200 mcg
n=146 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 100 mcg
n=145 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Placebo MDPI
n=142 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over the 12-Week Treatment Period
|
-0.391 units on a scale
Standard Error 0.0328
|
-0.364 units on a scale
Standard Error 0.0332
|
-0.242 units on a scale
Standard Error 0.0329
|
-0.282 units on a scale
Standard Error 0.0333
|
-0.087 units on a scale
Standard Error 0.0342
|
SECONDARY outcome
Timeframe: Days -6 to Day 1 (predose, baseline), up to week 12Population: Full analysis set
Patients recorded the number of inhalations of rescue medication (albuterol/salbutamol HFA MDI) each AM and PM in the diary. The average number of daily inhalations over the 7 days before the randomization visit was the baseline value. The weekly average was based on the available data for the 7 days before each analysis week. The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using a mixed model for repeated measures.
Outcome measures
| Measure |
FS MDPI 200 / 12.5 mcg
n=145 Participants
Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 100 / 12.5 mcg
n=141 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 200 mcg
n=146 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 100 mcg
n=145 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Placebo MDPI
n=143 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Weekly Average of the Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol Over the 12-Week Treatment Period
|
-0.898 puffs
Standard Error 0.1069
|
-0.821 puffs
Standard Error 0.1080
|
-0.534 puffs
Standard Error 0.1070
|
-0.439 puffs
Standard Error 0.1081
|
0.168 puffs
Standard Error 0.1102
|
SECONDARY outcome
Timeframe: up to Week 12 of the Treatment PeriodPopulation: Full analysis set
The analysis of probability of remaining in the study at Week 12 used the time to patient withdrawal for worsening asthma, defined as the number of days elapsed from the date of randomization to the date of withdrawal due to worsening asthma. Patients who were lost to follow-up, who had not withdrawn due to worsening asthma by week 12, or who had withdrawn due to reasons other than worsening asthma were right-censored at the date of last assessment.
Outcome measures
| Measure |
FS MDPI 200 / 12.5 mcg
n=145 Participants
Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 100 / 12.5 mcg
n=141 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 200 mcg
n=146 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 100 mcg
n=145 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Placebo MDPI
n=143 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
|---|---|---|---|---|---|
|
Kaplan-Meier Estimate of Probability of Remaining in Study At Week 12
|
0.9719 probability
Interval 0.927 to 0.989
|
0.9929 probability
Interval 0.95 to 0.999
|
0.9786 probability
Interval 0.935 to 0.993
|
0.9930 probability
Interval 0.951 to 0.999
|
0.8528 probability
Interval 0.781 to 0.903
|
SECONDARY outcome
Timeframe: Day 1 (predose, baseline), end of trial (up to week 12)Population: Full analysis set of participants who contributed at least once to analysis and were \>= 18 years old
The AQLQ(S) (September 2010 version; patients aged ≥18 years) was self administered by the patients at the investigational center at the randomization visit and at Week 12 or end of trial. The questionnaire is a tool to measure the impact of asthma on a patient's quality of life (physical, emotional, social, and occupational) with a recall period of 2 weeks. The AQLQ(S) was administered only to patients 18 years and older. The 32 individual questions in the AQLQ were equally weighted. The overall AQLQ score was the mean of the responses to each of the 32 questions, and ranged from 1 to 7. A score 7.0 indicated that the patient had no impairments due to asthma and a score of 1.0 indicated severe impairment. Positive change from baseline scores indicate improved quality of life.
Outcome measures
| Measure |
FS MDPI 200 / 12.5 mcg
n=131 Participants
Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 100 / 12.5 mcg
n=135 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 200 mcg
n=132 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 100 mcg
n=133 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Placebo MDPI
n=129 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ(S)) Score at Endpoint for Patients >=18 Years Old
|
0.534 units on a scale
Standard Error 0.0741
|
0.592 units on a scale
Standard Error 0.0725
|
0.384 units on a scale
Standard Error 0.0742
|
0.340 units on a scale
Standard Error 0.0740
|
-0.089 units on a scale
Standard Error 0.0747
|
SECONDARY outcome
Timeframe: Day 1 of the Treatment Period (predose and postdose)Population: Patients who did not achieve the target improvement were censored at the time of last serial spirometry assessment.
The baseline forced expiratory volume in 1 second (FEV1) was the average of the 2 predose FEV1 measurements (30 and 10 minutes predose) on Day 1. If one of these was missing, the other measurement was used as baseline value. If both were missing, the baseline trough FEV1 was treated as missing. Time to target improvement (15% or 12%) was defined as the time elapsed from the time of first dose to the first time the target improvement in FEV1 was achieved. If an exact target increase was not achieved at a measured timepoint, then the time was estimated by linear interpolation between the timepoint when target was reached and the timepoint immediately before. Patients who did not achieve the target improvement were censored at the time of last serial spirometry assessment. Values of NA indicate the values could not be estimated which happened when the estimated probability of not achieving target is more than 50%.
Outcome measures
| Measure |
FS MDPI 200 / 12.5 mcg
n=68 Participants
Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 100 / 12.5 mcg
n=58 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 200 mcg
n=61 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 100 mcg
n=64 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Placebo MDPI
n=61 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
|---|---|---|---|---|---|
|
Kaplan-Meier Estimates for Time to 15% and 12% Improvement From Baseline in FEV1 Postdose on Day 1
15% improvement
|
0.8 hours
Interval 0.31 to 1.77
|
0.9 hours
Interval 0.48 to 11.96
|
NA hours
Interval 3.84 to
estimated probability of not achieving target is more than 50%.
|
NA hours
estimated probability of not achieving target is more than 50%.
|
NA hours
estimated probability of not achieving target is more than 50%.
|
|
Kaplan-Meier Estimates for Time to 15% and 12% Improvement From Baseline in FEV1 Postdose on Day 1
12% improvement
|
0.4 hours
Interval 0.25 to 0.81
|
0.4 hours
Interval 0.29 to 1.68
|
6.9 hours
Interval 2.69 to
estimated probability of not achieving target is more than 50%.
|
NA hours
Interval 5.58 to
estimated probability of not achieving target is more than 50%.
|
NA hours
Interval 5.68 to
estimated probability of not achieving target is more than 50%.
|
SECONDARY outcome
Timeframe: Day 1 to Week 12 of the Treatment PeriodPopulation: Safety population
An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Outcome measures
| Measure |
FS MDPI 200 / 12.5 mcg
n=145 Participants
Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 100 / 12.5 mcg
n=143 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 200 mcg
n=146 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 100 mcg
n=145 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Placebo MDPI
n=144 Participants
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
|---|---|---|---|---|---|
|
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
>=1 TEAE
|
61 Participants
|
59 Participants
|
60 Participants
|
53 Participants
|
52 Participants
|
|
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
>=1 severe TEAE
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
>=1 treatment-related TEAE
|
8 Participants
|
4 Participants
|
9 Participants
|
6 Participants
|
5 Participants
|
|
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
>=1 severe treatment-related TEAE
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
>=1 serious TEAE
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
>=1 TEAE leading to withdrawal
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
>=1 nonserious TEAE
|
61 Participants
|
58 Participants
|
60 Participants
|
52 Participants
|
52 Participants
|
|
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
>=1 TEAE resulting in death
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
FS MDPI 100/12.5 mcg
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
FS MDPI 200/12.5 mcg
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Fp MDPI 100 mcg
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Fp MDPI 200 mcg
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FS MDPI 100/12.5 mcg
n=143 participants at risk
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 200/12.5 mcg
n=145 participants at risk
Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 100 mcg
n=145 participants at risk
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 200 mcg
n=146 participants at risk
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Placebo
n=144 participants at risk
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/143 • Day 1 up to Week 14
|
0.00%
0/145 • Day 1 up to Week 14
|
0.00%
0/145 • Day 1 up to Week 14
|
0.68%
1/146 • Number of events 1 • Day 1 up to Week 14
|
0.00%
0/144 • Day 1 up to Week 14
|
|
Hepatobiliary disorders
Jaundice
|
0.70%
1/143 • Number of events 1 • Day 1 up to Week 14
|
0.00%
0/145 • Day 1 up to Week 14
|
0.00%
0/145 • Day 1 up to Week 14
|
0.00%
0/146 • Day 1 up to Week 14
|
0.00%
0/144 • Day 1 up to Week 14
|
|
Infections and infestations
Pneumonia
|
0.00%
0/143 • Day 1 up to Week 14
|
0.69%
1/145 • Number of events 1 • Day 1 up to Week 14
|
0.00%
0/145 • Day 1 up to Week 14
|
0.00%
0/146 • Day 1 up to Week 14
|
0.00%
0/144 • Day 1 up to Week 14
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.70%
1/143 • Number of events 1 • Day 1 up to Week 14
|
0.00%
0/145 • Day 1 up to Week 14
|
0.00%
0/145 • Day 1 up to Week 14
|
0.00%
0/146 • Day 1 up to Week 14
|
0.00%
0/144 • Day 1 up to Week 14
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/143 • Day 1 up to Week 14
|
0.00%
0/145 • Day 1 up to Week 14
|
0.69%
1/145 • Number of events 1 • Day 1 up to Week 14
|
0.00%
0/146 • Day 1 up to Week 14
|
0.00%
0/144 • Day 1 up to Week 14
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/143 • Day 1 up to Week 14
|
0.69%
1/145 • Number of events 1 • Day 1 up to Week 14
|
0.00%
0/145 • Day 1 up to Week 14
|
0.00%
0/146 • Day 1 up to Week 14
|
0.69%
1/144 • Number of events 1 • Day 1 up to Week 14
|
Other adverse events
| Measure |
FS MDPI 100/12.5 mcg
n=143 participants at risk
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 200/12.5 mcg
n=145 participants at risk
Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 100 mcg
n=145 participants at risk
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 200 mcg
n=146 participants at risk
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Placebo
n=144 participants at risk
Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.
Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.0%
10/143 • Number of events 10 • Day 1 up to Week 14
|
6.9%
10/145 • Number of events 12 • Day 1 up to Week 14
|
4.8%
7/145 • Number of events 7 • Day 1 up to Week 14
|
4.8%
7/146 • Number of events 8 • Day 1 up to Week 14
|
5.6%
8/144 • Number of events 9 • Day 1 up to Week 14
|
|
Infections and infestations
Upper respiratory tract infection
|
4.2%
6/143 • Number of events 6 • Day 1 up to Week 14
|
4.1%
6/145 • Number of events 6 • Day 1 up to Week 14
|
6.2%
9/145 • Number of events 11 • Day 1 up to Week 14
|
5.5%
8/146 • Number of events 9 • Day 1 up to Week 14
|
4.9%
7/144 • Number of events 7 • Day 1 up to Week 14
|
|
Nervous system disorders
Headache
|
4.2%
6/143 • Number of events 21 • Day 1 up to Week 14
|
2.8%
4/145 • Number of events 5 • Day 1 up to Week 14
|
7.6%
11/145 • Number of events 18 • Day 1 up to Week 14
|
4.8%
7/146 • Number of events 7 • Day 1 up to Week 14
|
4.9%
7/144 • Number of events 10 • Day 1 up to Week 14
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 215-591-3000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER