Trial Outcomes & Findings for Study of Fluticasone Propionate MDPI Compared With Fluticasone/Salmeterol MDPI in Adolescent and Adult Patients With Persistent Asthma (NCT NCT02139644)
NCT ID: NCT02139644
Last Updated: 2021-11-12
Results Overview
A subset of approximately 300 patients who performed postdose serial spirometry is based on sample size calculation. 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
787 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
2021-11-12
Participant Flow
A total of 1363 patients with persistent asthma were screened for enrollment into this study. 787 patients at 129 investigational centers in the US and elsewhere internationally met entry criteria and were considered eligible for enrollment into the study.
Patients were randomized 1:1:1:1:1 to one of the five treatment arms during the Treatment Period.
Participant milestones
| Measure |
Enrolled Patients
During the run-in period (from the screening visit to the randomization visit), all patients replaced their current rescue medication with study-specific rescue medication (albuterol/salbutamol HFA MDI) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the period. All patients discontinued their current ICS or ICS/LABA, and took 1 inhalation twice a day from a single-blinded placebo MDPI device and 1 puff twice a day from open-label QVAR 40 mcg HFA MDI (or equivalent).
|
FS MDPI 100 / 12.5 mcg
Patients 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/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 50 / 12.5 mcg
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol 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
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 50 mcg
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Placebo MDPI
The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol 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
|
787
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
COMPLETED
|
647
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
NOT COMPLETED
|
140
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
STARTED
|
0
|
129
|
129
|
130
|
129
|
130
|
|
Treatment Period
COMPLETED
|
0
|
126
|
121
|
121
|
121
|
113
|
|
Treatment Period
NOT COMPLETED
|
0
|
3
|
8
|
9
|
8
|
17
|
Reasons for withdrawal
| Measure |
Enrolled Patients
During the run-in period (from the screening visit to the randomization visit), all patients replaced their current rescue medication with study-specific rescue medication (albuterol/salbutamol HFA MDI) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the period. All patients discontinued their current ICS or ICS/LABA, and took 1 inhalation twice a day from a single-blinded placebo MDPI device and 1 puff twice a day from open-label QVAR 40 mcg HFA MDI (or equivalent).
|
FS MDPI 100 / 12.5 mcg
Patients 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/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 50 / 12.5 mcg
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol 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
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 50 mcg
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Placebo MDPI
The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol 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)
Randomization criteria not met
|
70
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
Inclusion criteria not met
|
30
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
Withdrawal by Subject
|
12
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
Exclusion criteria met
|
11
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
Lost to Follow-up
|
8
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
Adverse Event
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
Other
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
Adverse Event
|
0
|
0
|
3
|
2
|
1
|
6
|
|
Treatment Period
Withdrawal by Subject
|
0
|
0
|
2
|
2
|
3
|
2
|
|
Treatment Period
Non-compliance
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period
Protocol Violation
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Treatment Period
Disease progression
|
0
|
0
|
0
|
1
|
1
|
2
|
|
Treatment Period
Lost to Follow-up
|
0
|
0
|
1
|
1
|
1
|
1
|
|
Treatment Period
Lack of Efficacy
|
0
|
0
|
1
|
0
|
1
|
4
|
|
Treatment Period
Other
|
0
|
3
|
1
|
1
|
0
|
1
|
Baseline Characteristics
Study of Fluticasone Propionate MDPI Compared With Fluticasone/Salmeterol MDPI in Adolescent and Adult Patients With Persistent Asthma
Baseline characteristics by cohort
| Measure |
FS MDPI 100 / 12.5 mcg
n=129 Participants
Patients 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/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 50 / 12.5 mcg
n=129 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol 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=130 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 50 mcg
n=129 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol 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=130 Participants
The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Total
n=647 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.0 years
STANDARD_DEVIATION 17.00 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 18.61 • n=7 Participants
|
40.6 years
STANDARD_DEVIATION 17.16 • n=5 Participants
|
43.3 years
STANDARD_DEVIATION 17.96 • n=4 Participants
|
40.9 years
STANDARD_DEVIATION 17.35 • n=21 Participants
|
41.5 years
STANDARD_DEVIATION 17.60 • n=8 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
86 Participants
n=8 Participants
|
|
Age, Customized
Adults (18-64 years)
|
100 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
102 Participants
n=21 Participants
|
494 Participants
n=8 Participants
|
|
Age, Customized
Adults (65+ years)
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
67 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
364 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
283 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
105 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
101 Participants
n=21 Participants
|
515 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
113 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
119 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
122 Participants
n=21 Participants
|
597 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
49 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Body Mass Index
|
27.94 kg/m^2
STANDARD_DEVIATION 6.686 • n=5 Participants
|
28.00 kg/m^2
STANDARD_DEVIATION 7.166 • n=7 Participants
|
27.63 kg/m^2
STANDARD_DEVIATION 6.603 • n=5 Participants
|
27.94 kg/m^2
STANDARD_DEVIATION 7.259 • n=4 Participants
|
27.99 kg/m^2
STANDARD_DEVIATION 6.849 • n=21 Participants
|
27.90 kg/m^2
STANDARD_DEVIATION 6.897 • n=8 Participants
|
|
History of Smoking
Prior smoker
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
72 Participants
n=8 Participants
|
|
History of Smoking
No tobacco use
|
111 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
118 Participants
n=21 Participants
|
575 Participants
n=8 Participants
|
|
Previous Asthma Therapy
Inhaled corticosteroid
|
97 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
102 Participants
n=21 Participants
|
461 Participants
n=8 Participants
|
|
Previous Asthma Therapy
Inhaled corticosteroid/long-acting beta2-agonist
|
32 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
186 Participants
n=8 Participants
|
|
Forced Expiratory Volume in 1 second (FEV1)
|
2.162 liters
STANDARD_DEVIATION 0.5522 • n=5 Participants
|
2.302 liters
STANDARD_DEVIATION 0.6526 • n=7 Participants
|
2.166 liters
STANDARD_DEVIATION 0.5725 • n=5 Participants
|
2.134 liters
STANDARD_DEVIATION 0.6362 • n=4 Participants
|
2.188 liters
STANDARD_DEVIATION 0.5628 • n=21 Participants
|
2.190 liters
STANDARD_DEVIATION 0.5977 • n=8 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 hoursPopulation: Full analysis set: a subset of patients who performed postdose serial spirometry at the baseline visit and week 12
A subset of approximately 300 patients who performed postdose serial spirometry is based on sample size calculation. 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 100 / 12.5 mcg
n=61 Participants
Patients 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/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 50 / 12.5 mcg
n=56 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol 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=72 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 50 mcg
n=63 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol 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=60 Participants
The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol 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 AUEC0-12h) at Week 12
|
0.408 liters
Standard Error 0.0465
|
0.399 liters
Standard Error 0.0479
|
0.254 liters
Standard Error 0.0434
|
0.268 liters
Standard Error 0.0457
|
0.074 liters
Standard Error 0.0487
|
PRIMARY outcome
Timeframe: Day 1 (predose, baseline), Week 12Population: Full analysis set
Trough FEV1 was a morning spirometry taken predose and pre-rescue bronchodilator. 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. 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 100 / 12.5 mcg
n=126 Participants
Patients 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/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 50 / 12.5 mcg
n=128 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol 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=129 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 50 mcg
n=128 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol 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
The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol 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
|
0.315 liters
Standard Error 0.0352
|
0.319 liters
Standard Error 0.0350
|
0.204 liters
Standard Error 0.0340
|
0.172 liters
Standard Error 0.0347
|
0.053 liters
Standard Error 0.0350
|
SECONDARY outcome
Timeframe: Days -6 to Day 1 (predose), Day 1 (postdose) daily until Week 12Population: Full analysis set of patients who contributed at least once to the analysis.
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 100 / 12.5 mcg
n=125 Participants
Patients 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/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 50 / 12.5 mcg
n=128 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol 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=129 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 50 mcg
n=128 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol 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=128 Participants
The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol 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
|
24.415 liters/minute
Standard Error 3.1530
|
24.864 liters/minute
Standard Error 3.1182
|
14.517 liters/minute
Standard Error 3.0778
|
10.609 liters/minute
Standard Error 3.1176
|
3.591 liters/minute
Standard Error 3.1474
|
SECONDARY outcome
Timeframe: Days -6 to Day 1 (predose, baseline) to Week 12Population: Full analysis set of patients who contributed at least once to the analysis.
The total daily asthma symptom score is the average of the daytime and nighttime scores as recorded in the patient diary (range 0-9). 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 100 / 12.5 mcg
n=125 Participants
Patients 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/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 50 / 12.5 mcg
n=128 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol 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=129 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 50 mcg
n=128 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol 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=128 Participants
The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol 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
|
-0.364 units on a scale
Standard Error 0.0318
|
-0.329 units on a scale
Standard Error 0.0314
|
-0.300 units on a scale
Standard Error 0.0308
|
-0.278 units on a scale
Standard Error 0.0314
|
-0.135 units on a scale
Standard Error 0.0318
|
SECONDARY outcome
Timeframe: Days -6 to Day 1 (predose, baseline), up to week 12Population: FAS of patients who contributed at least once to the analysis
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 100 / 12.5 mcg
n=126 Participants
Patients 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/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 50 / 12.5 mcg
n=128 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol 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=129 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 50 mcg
n=128 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol 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
The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol 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
|
-0.677 puffs
Standard Error 0.0937
|
-0.706 puffs
Standard Error 0.0930
|
-0.466 puffs
Standard Error 0.0915
|
-0.467 puffs
Standard Error 0.0928
|
-0.003 puffs
Standard Error 0.0937
|
SECONDARY outcome
Timeframe: up to Week 12 of the Treatment PeriodPopulation: FAS
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 100 / 12.5 mcg
n=126 Participants
Patients 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/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 50 / 12.5 mcg
n=128 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol 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=129 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 50 mcg
n=128 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol 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
The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol 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
|
1.0000 probability
Interval 1.0 to 1.0
|
0.9917 probability
Interval 0.942 to 0.999
|
0.9919 probability
Interval 0.944 to 0.999
|
0.9919 probability
Interval 0.944 to 0.999
|
0.9681 probability
Interval 0.917 to 0.988
|
SECONDARY outcome
Timeframe: Day 1 (predose, baseline), end of trial (up to week 12)Population: FAS patients 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 of 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 100 / 12.5 mcg
n=109 Participants
Patients 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/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 50 / 12.5 mcg
n=102 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol 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=103 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 50 mcg
n=108 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol 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=97 Participants
The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol 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
|
0.808 units on a scale
Standard Error 0.0728
|
0.565 units on a scale
Standard Error 0.0752
|
0.636 units on a scale
Standard Error 0.0736
|
0.588 units on a scale
Standard Error 0.0733
|
0.335 units on a scale
Standard Error 0.0777
|
SECONDARY outcome
Timeframe: Day 1 of the Treatment Period (predose and postdose)Population: Full analysis set: a subset of patients who performed postdose serial spirometry on Day 1
A subset of approximately 300 patients who performed postdose serial spirometry is based on sample size calculation. Baseline FEV1 was the average of 2 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, baseline 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 9999 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 100 / 12.5 mcg
n=61 Participants
Patients 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/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 50 / 12.5 mcg
n=56 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol 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=72 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 50 mcg
n=63 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol 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=60 Participants
The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol 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
|
4.3 hours
Interval 1.07 to
values could not be estimated which happened when the estimated probability of not achieving target is more than 50%.
|
1.3 hours
Interval 0.6 to 2.75
|
NA hours
Interval 10.19 to
values could not be estimated which happened when the estimated probability of not achieving target is more than 50%.
|
NA hours
values could not be estimated which happened when the estimated probability of not achieving target is more than 50%.
|
NA hours
values could not be estimated which happened when the 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
|
1.0 hours
Interval 0.46 to 3.72
|
0.5 hours
Interval 0.3 to 1.55
|
NA hours
Interval 7.37 to
values could not be estimated which happened when the estimated probability of not achieving target is more than 50%.
|
NA hours
Interval 3.89 to
values could not be estimated which happened when the estimated probability of not achieving target is more than 50%.
|
NA hours
Interval 7.27 to
values could not be estimated which happened when the 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. Relationship 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 100 / 12.5 mcg
n=126 Participants
Patients 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/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 50 / 12.5 mcg
n=128 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol 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=129 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 50 mcg
n=129 Participants
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol 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
The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol 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
|
37 Participants
|
46 Participants
|
40 Participants
|
44 Participants
|
47 Participants
|
|
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
>=1 severe TEAE
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
>=1 treatment-related TEAE
|
4 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
|
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
>=1 severe treatment-related TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
>=1 serious TEAE
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
>=1 TEAE leading to withdrawal
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
|
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
>=1 nonserious TEAE
|
36 Participants
|
46 Participants
|
39 Participants
|
44 Participants
|
45 Participants
|
|
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
>=1 TEAE resulting in death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
FS MDPI 100 / 12.5 mcg
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
FS MDPI 50 / 12.5 mcg
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Fp MDPI 100 mcg
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Fp MDPI 50 mcg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo MDPI
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FS MDPI 100 / 12.5 mcg
n=126 participants at risk
Patients 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/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 50 / 12.5 mcg
n=128 participants at risk
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol 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=129 participants at risk
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 50 mcg
n=129 participants at risk
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol 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 at risk
The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.79%
1/126 • Number of events 1 • Day 1 up to Week 12
|
0.00%
0/128 • Day 1 up to Week 12
|
0.00%
0/129 • Day 1 up to Week 12
|
0.00%
0/129 • Day 1 up to Week 12
|
0.00%
0/129 • Day 1 up to Week 12
|
|
Hepatobiliary disorders
Cholecystitis
|
0.79%
1/126 • Number of events 1 • Day 1 up to Week 12
|
0.00%
0/128 • Day 1 up to Week 12
|
0.00%
0/129 • Day 1 up to Week 12
|
0.00%
0/129 • Day 1 up to Week 12
|
0.00%
0/129 • Day 1 up to Week 12
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.79%
1/126 • Number of events 1 • Day 1 up to Week 12
|
0.00%
0/128 • Day 1 up to Week 12
|
0.00%
0/129 • Day 1 up to Week 12
|
0.00%
0/129 • Day 1 up to Week 12
|
0.00%
0/129 • Day 1 up to Week 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/126 • Day 1 up to Week 12
|
0.00%
0/128 • Day 1 up to Week 12
|
0.78%
1/129 • Number of events 1 • Day 1 up to Week 12
|
0.00%
0/129 • Day 1 up to Week 12
|
0.00%
0/129 • Day 1 up to Week 12
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/126 • Day 1 up to Week 12
|
0.00%
0/128 • Day 1 up to Week 12
|
0.00%
0/129 • Day 1 up to Week 12
|
0.00%
0/129 • Day 1 up to Week 12
|
0.78%
1/129 • Number of events 1 • Day 1 up to Week 12
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/126 • Day 1 up to Week 12
|
0.00%
0/128 • Day 1 up to Week 12
|
0.00%
0/129 • Day 1 up to Week 12
|
0.00%
0/129 • Day 1 up to Week 12
|
0.78%
1/129 • Number of events 1 • Day 1 up to Week 12
|
Other adverse events
| Measure |
FS MDPI 100 / 12.5 mcg
n=126 participants at risk
Patients 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/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FS MDPI 50 / 12.5 mcg
n=128 participants at risk
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.
Albuterol/salbutamol 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=129 participants at risk
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Fp MDPI 50 mcg
n=129 participants at risk
Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.
Albuterol/salbutamol 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 at risk
The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).
Albuterol/salbutamol 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
|
2.4%
3/126 • Number of events 3 • Day 1 up to Week 12
|
8.6%
11/128 • Number of events 11 • Day 1 up to Week 12
|
7.0%
9/129 • Number of events 10 • Day 1 up to Week 12
|
5.4%
7/129 • Number of events 8 • Day 1 up to Week 12
|
3.1%
4/129 • Number of events 5 • Day 1 up to Week 12
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
2/126 • Number of events 2 • Day 1 up to Week 12
|
4.7%
6/128 • Number of events 6 • Day 1 up to Week 12
|
3.1%
4/129 • Number of events 4 • Day 1 up to Week 12
|
5.4%
7/129 • Number of events 8 • Day 1 up to Week 12
|
4.7%
6/129 • Number of events 6 • Day 1 up to Week 12
|
|
Nervous system disorders
Headache
|
5.6%
7/126 • Number of events 10 • Day 1 up to Week 12
|
5.5%
7/128 • Number of events 8 • Day 1 up to Week 12
|
7.0%
9/129 • Number of events 11 • Day 1 up to Week 12
|
1.6%
2/129 • Number of events 4 • Day 1 up to Week 12
|
3.9%
5/129 • Number of events 7 • Day 1 up to Week 12
|
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