Trial Outcomes & Findings for Long-Term Safety Study of Fluticasone Propionate (Fp) Multidose Dry Powder Inhaler (MDPI) and Fluticasone Propionate/Salmeterol (FS) MDPI in Patients With Persistent Asthma (NCT NCT02175771)
NCT ID: NCT02175771
Last Updated: 2021-11-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
758 participants
Primary outcome timeframe
Day 1 to Week 26 of the Treatment Period
Results posted on
2021-11-09
Participant Flow
Of the 1087 patients screened, 758 patients at 103 investigational centers in the US met entry criteria. 331 patients were not enrolled: 267 due to inclusion/exclusion criteria, 21 withdrew consent, 9 were lost to follow up, 4 had an adverse event, and 30 patients had reason of 'other' or missing.
Participants in each strength of the ICS monotherapy cohort were randomly assigned in a 3:1 distribution to either the Fp MDPI or FLOVENT HFA treatment arm. Participants in each strength of the ICS/LABA combination cohort were randomly assigned in a 3:1 distribution to either the FS MDPI or ADVAIR DISKUS treatment arm.
Participant milestones
| Measure |
Enrolled Patients
During the run-in period, patients continued using their current asthma medications (ie, inhaled corticosteroid and/or other controller therapies) except for their short acting beta2-agonist (SABA), which was replaced by the sponsor-provided study rescue medication.
|
Fp MDPI 100 mcg
Participants 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 Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FLOVENT HFA 110 mcg
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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
Participants 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 Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FLOVENT HFA 220 mcg
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
ADVAIR DISKUS 250/50 mcg
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol 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
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
ADVAIR DISKUS 500/50 mcg
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol 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
|
758
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
COMPLETED
|
674
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
NOT COMPLETED
|
84
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
STARTED
|
0
|
127
|
42
|
126
|
41
|
120
|
41
|
133
|
44
|
|
Treatment Period
COMPLETED
|
0
|
111
|
35
|
113
|
36
|
110
|
36
|
116
|
38
|
|
Treatment Period
NOT COMPLETED
|
0
|
16
|
7
|
13
|
5
|
10
|
5
|
17
|
6
|
Reasons for withdrawal
| Measure |
Enrolled Patients
During the run-in period, patients continued using their current asthma medications (ie, inhaled corticosteroid and/or other controller therapies) except for their short acting beta2-agonist (SABA), which was replaced by the sponsor-provided study rescue medication.
|
Fp MDPI 100 mcg
Participants 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 Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FLOVENT HFA 110 mcg
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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
Participants 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 Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FLOVENT HFA 220 mcg
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
ADVAIR DISKUS 250/50 mcg
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol 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
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
ADVAIR DISKUS 500/50 mcg
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol 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
|
23
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
Exclusion criteria met
|
20
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
Withdrawal by Subject
|
11
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
Adverse Event
|
9
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
Inclusion criteria not met
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
Lost to Follow-up
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Run-In Period (Pre-assignment)
Other
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
Adverse Event
|
0
|
2
|
1
|
1
|
1
|
3
|
2
|
0
|
1
|
|
Treatment Period
Withdrawal by Subject
|
0
|
9
|
3
|
6
|
2
|
4
|
2
|
9
|
2
|
|
Treatment Period
Noncompliance
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period
Disease progression
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Treatment Period
Lost to Follow-up
|
0
|
3
|
1
|
3
|
1
|
2
|
1
|
2
|
2
|
|
Treatment Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Treatment Period
Other
|
0
|
1
|
0
|
3
|
1
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Long-Term Safety Study of Fluticasone Propionate (Fp) Multidose Dry Powder Inhaler (MDPI) and Fluticasone Propionate/Salmeterol (FS) MDPI in Patients With Persistent Asthma
Baseline characteristics by cohort
| Measure |
Fp MDPI 100 mcg
n=127 Participants
Participants 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 Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FLOVENT HFA 110 mcg
n=42 Participants
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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=126 Participants
Participants 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 Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FLOVENT HFA 220 mcg
n=41 Participants
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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=120 Participants
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
ADVAIR DISKUS 250/50 mcg
n=41 Participants
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol 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=133 Participants
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
ADVAIR DISKUS 500/50 mcg
n=44 Participants
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
Total
n=674 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Adolescents (12-17 years)
|
19 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
73 Participants
n=6 Participants
|
|
Age, Customized
Adults (18-64 years)
|
96 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
31 Participants
n=10 Participants
|
106 Participants
n=115 Participants
|
41 Participants
n=6 Participants
|
531 Participants
n=6 Participants
|
|
Age, Customized
Adults (65+ years)
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
68 Participants
n=6 Participants
|
|
Age, Customized
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Sex/Gender, Customized
Male
|
49 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
61 Participants
n=115 Participants
|
21 Participants
n=6 Participants
|
266 Participants
n=6 Participants
|
|
Sex/Gender, Customized
Female
|
78 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
72 Participants
n=115 Participants
|
23 Participants
n=6 Participants
|
406 Participants
n=6 Participants
|
|
Sex/Gender, Customized
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
118 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
99 Participants
n=21 Participants
|
36 Participants
n=10 Participants
|
112 Participants
n=115 Participants
|
39 Participants
n=6 Participants
|
576 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
95 Participants
n=6 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
110 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
99 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
95 Participants
n=115 Participants
|
31 Participants
n=6 Participants
|
528 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
31 Participants
n=115 Participants
|
12 Participants
n=6 Participants
|
127 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
9 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
History of Smoking
Prior smoker
|
26 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
8 Participants
n=6 Participants
|
123 Participants
n=6 Participants
|
|
History of Smoking
No tobacco use
|
101 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
109 Participants
n=115 Participants
|
36 Participants
n=6 Participants
|
551 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Week 26 of the Treatment PeriodPopulation: Safety population which included all randomized participants who received at least 1 dose of randomized study drug. The randomization allocation ratio of 3:1 (study drug: active comparator) should be taken into account when comparing treatment groups within treatment/strength cohorts
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 |
Fp MDPI 100 mcg
n=127 Participants
Participants 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 Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FLOVENT HFA 110 mcg
n=42 Participants
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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=125 Participants
Participants 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 Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FLOVENT HFA 220 mcg
n=41 Participants
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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=120 Participants
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
ADVAIR DISKUS 250/50 mcg
n=41 Participants
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol 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=133 Participants
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
ADVAIR DISKUS 500/50 mcg
n=44 Participants
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
|---|---|---|---|---|---|---|---|---|
|
Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
>=1 TEAE leading to withdrawal
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
>=1 TEAE
|
85 Participants
|
29 Participants
|
83 Participants
|
29 Participants
|
92 Participants
|
29 Participants
|
86 Participants
|
30 Participants
|
|
Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
>=1 severe TEAE
|
8 Participants
|
3 Participants
|
11 Participants
|
3 Participants
|
8 Participants
|
1 Participants
|
12 Participants
|
3 Participants
|
|
Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
>=1 treatment-related TEAE
|
10 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
9 Participants
|
4 Participants
|
11 Participants
|
8 Participants
|
|
Participants 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
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
>=1 serious TEAE
|
7 Participants
|
2 Participants
|
8 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
13 Participants
|
3 Participants
|
|
Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
>=1 nonserious TEAE
|
85 Participants
|
27 Participants
|
82 Participants
|
29 Participants
|
91 Participants
|
28 Participants
|
85 Participants
|
29 Participants
|
|
Participants 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
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, EndpointPopulation: Safety population
Oropharyngeal examinations for visual evidence of oral candidiasis were conducted at each visit by a qualified healthcare professional. Any visual evidence of oral candidiasis during the oropharyngeal exam was evaluated by obtaining and analyzing a swab of the suspect area. This outcomes indicates how many participants had positive swab test results. The total number of participants who had oropharyngeal exams at each timepoint are specified in the timepoint field. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation. Participants with a culture-positive infection could continue participation in the study on appropriate anti-infective therapy, provided this therapy was not prohibited by the protocol.
Outcome measures
| Measure |
Fp MDPI 100 mcg
n=127 Participants
Participants 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 Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FLOVENT HFA 110 mcg
n=42 Participants
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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=125 Participants
Participants 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 Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FLOVENT HFA 220 mcg
n=41 Participants
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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=120 Participants
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
ADVAIR DISKUS 250/50 mcg
n=41 Participants
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol 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=133 Participants
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
ADVAIR DISKUS 500/50 mcg
n=44 Participants
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
|---|---|---|---|---|---|---|---|---|
|
Participants With Positive Swab Test Results for Oral Candidiasis
Week 26 (n=111, 35, 113, 36, 110, 36, 116, 38)
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Positive Swab Test Results for Oral Candidiasis
Week 18 (n=111, 37, 115, 38, 109, 38, 117, 40)
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Positive Swab Test Results for Oral Candidiasis
Week 22 (n=110, 36, 113, 36, 110, 37, 116, 38)
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Participants With Positive Swab Test Results for Oral Candidiasis
Endpoint (n=125, 42, 123, 41, 119, 40, 132, 44)
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Positive Swab Test Results for Oral Candidiasis
Week 14 (n=116, 36, 115, 38, 113, 38, 120, 41)
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Participants With Positive Swab Test Results for Oral Candidiasis
Baseline (n=127, 42, 124, 41, 120, 41, 133, 44)
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Positive Swab Test Results for Oral Candidiasis
Week 2 (n=123, 42, 123, 40, 117, 39, 131, 43)
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Participants With Positive Swab Test Results for Oral Candidiasis
Week 6 (n=119, 41, 119, 40, 115, 39, 125, 43)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Participants With Positive Swab Test Results for Oral Candidiasis
Week 10 (n=119, 37, 118, 39, 115, 39, 120, 40)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, EndpointPopulation: Safety population of participants with a baseline and postbaseline vital sign value.
Data represents participants with potentially clinically significant (PCS) vital sign values during the Treatment period. Significance criteria: * Systolic blood pressure - high: \>=180 and increase \>=20 mmHg * Systolic blood pressure - low: \<=90 and decrease \>=20 mmHg * Diastolic blood pressure - high: \>=105 and increase of \>=15 mmHg * Diastolic blood pressure - low: \<=50 and decrease of \>=15 mmHg * Pulse - high: \>=120 and increase of \>= 15 beats/minute from baseline * Pulse - low: \<=50 and decrease of \>=15 beats/minute
Outcome measures
| Measure |
Fp MDPI 100 mcg
n=125 Participants
Participants 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 Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FLOVENT HFA 110 mcg
n=42 Participants
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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=123 Participants
Participants 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 Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FLOVENT HFA 220 mcg
n=41 Participants
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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=119 Participants
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
ADVAIR DISKUS 250/50 mcg
n=40 Participants
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol 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=132 Participants
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
ADVAIR DISKUS 500/50 mcg
n=44 Participants
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
|---|---|---|---|---|---|---|---|---|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period
>=1 abnormality
|
5 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period
Systolic blood pressure - high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period
Systolic blood pressure - low
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period
Diastolic blood pressure - high
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period
Diastolic blood pressure - low
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period
Pulse - high
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period
Pulse - low
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening (Day -14), Endpoint (week 26 if study was completed)Population: Safety population of participants with both screening and endpoint ECGs
A 12 lead ECG was conducted at the screening visit and week 26 or the early termination visit. A qualified physician at a central diagnostic center was responsible for interpreting the ECG. The worst post-baseline finding for the participant is summarized. Endpoint refers to the last observation carried forward.
Outcome measures
| Measure |
Fp MDPI 100 mcg
n=112 Participants
Participants 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 Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FLOVENT HFA 110 mcg
n=39 Participants
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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=116 Participants
Participants 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 Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FLOVENT HFA 220 mcg
n=39 Participants
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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=116 Participants
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
ADVAIR DISKUS 250/50 mcg
n=38 Participants
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol 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=125 Participants
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
ADVAIR DISKUS 500/50 mcg
n=39 Participants
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
|---|---|---|---|---|---|---|---|---|
|
Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings
Baseline normal - Endpoint normal
|
89 Participants
|
31 Participants
|
93 Participants
|
33 Participants
|
90 Participants
|
30 Participants
|
101 Participants
|
28 Participants
|
|
Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings
Baseline normal - Endpoint abnormal
|
8 Participants
|
5 Participants
|
6 Participants
|
1 Participants
|
9 Participants
|
2 Participants
|
8 Participants
|
3 Participants
|
|
Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings
Baseline abnormal - Endpoint normal
|
4 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
12 Participants
|
2 Participants
|
9 Participants
|
4 Participants
|
|
Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings
Baseline abnormal - Endpoint abnormal
|
11 Participants
|
2 Participants
|
13 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-treatment), Weeks 14 and 26 and early termination visit if applicablePopulation: A urine cortisol analysis subset of the safety population was defined that included participants whose urine samples did not have confounding factors at any visit that could affect the interpretation of the results.
Samples for 24-hour urine cortisol were collected at baseline (Day 1, pretreatment), and Weeks 14 and 26. For participants requiring early termination (ET), this evaluation was performed at the ET visit. For participants requiring ET for safety reasons, the visit was not delayed in order to collect the 24-hour urine cortisol. The analysis is based on a mixed model for repeated measures (MMRM) model with adjustment for visit, treatment, and a treatment\*visit interaction. The urine cortisol result is log transformed prior to analysis and the results are back transformed after modeling. An unstructured covariance matrix is used in the MMRM model.
Outcome measures
| Measure |
Fp MDPI 100 mcg
n=80 Participants
Participants 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 Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FLOVENT HFA 110 mcg
n=28 Participants
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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=93 Participants
Participants 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 Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FLOVENT HFA 220 mcg
n=28 Participants
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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=87 Participants
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
ADVAIR DISKUS 250/50 mcg
n=29 Participants
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol 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=91 Participants
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
ADVAIR DISKUS 500/50 mcg
n=38 Participants
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
|---|---|---|---|---|---|---|---|---|
|
Analysis of 24-Hour Urine Cortisol Free Over the 26-Week Treatment Period
|
18.45 mcg/24 hours
Interval 15.77 to 21.58
|
13.94 mcg/24 hours
Interval 10.67 to 18.22
|
14.14 mcg/24 hours
Interval 12.23 to 16.34
|
17.50 mcg/24 hours
Interval 13.4 to 22.85
|
17.56 mcg/24 hours
Interval 15.13 to 20.38
|
18.29 mcg/24 hours
Interval 14.07 to 23.77
|
13.02 mcg/24 hours
Interval 11.23 to 15.09
|
15.42 mcg/24 hours
Interval 12.27 to 19.38
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, early termination visit if applicablePopulation: The full analysis set (FAS) included all participants in the intent-to-treat (ITT) population who received at least 1 dose of study drug and had at least 1 post-baseline trough FEV1 assessment.
Spirometry measurements were obtained before the AM dose of study drug for the randomization visit (Day 1), at each of the treatment visits and at the early termination visit if applicable. At each visit where FEV1 was assessed, the highest acceptable results from each session were recorded. The analysis is based on a mixed model for repeated measures (MMRM) with adjustment for baseline FEV1, sex, age, (pooled) investigational center, visit, treatment, and treatment-by-visit. An unstructured covariance matrix is used in the MMRM model.
Outcome measures
| Measure |
Fp MDPI 100 mcg
n=123 Participants
Participants 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 Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FLOVENT HFA 110 mcg
n=42 Participants
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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=120 Participants
Participants 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 Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FLOVENT HFA 220 mcg
n=41 Participants
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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=119 Participants
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
ADVAIR DISKUS 250/50 mcg
n=40 Participants
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol 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=130 Participants
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
ADVAIR DISKUS 500/50 mcg
n=44 Participants
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol 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 Trough Forced Expiratory Volume in 1 Minute (FEV1) Over the 26-Week Treatment Period
|
0.062 liters
Standard Error 0.0243
|
0.053 liters
Standard Error 0.0415
|
0.077 liters
Standard Error 0.0246
|
0.090 liters
Standard Error 0.0415
|
0.116 liters
Standard Error 0.0251
|
0.117 liters
Standard Error 0.0419
|
0.100 liters
Standard Error 0.0235
|
0.041 liters
Standard Error 0.0399
|
Adverse Events
ADVAIR DISKUS 250/50 mcg
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
ADVAIR DISKUS 500/50 mcg
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
FLOVENT HFA 110 mcg
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
FLOVENT HFA 220 mcg
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
FS MDPI 100/12.5 mcg
Serious events: 6 serious events
Other events: 70 other events
Deaths: 0 deaths
FS MDPI 200/12.5 mcg
Serious events: 13 serious events
Other events: 68 other events
Deaths: 0 deaths
Fp MDPI 100 mcg
Serious events: 7 serious events
Other events: 65 other events
Deaths: 0 deaths
Fp MDPI 200 mcg
Serious events: 8 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ADVAIR DISKUS 250/50 mcg
n=41 participants at risk
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
ADVAIR DISKUS 500/50 mcg
n=44 participants at risk
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FLOVENT HFA 110 mcg
n=42 participants at risk
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FLOVENT HFA 220 mcg
n=41 participants at risk
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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=120 participants at risk
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol 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=133 participants at risk
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol 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=127 participants at risk
Participants 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 Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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=125 participants at risk
Participants 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 Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.00%
0/133 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.80%
1/125 • Number of events 1 • Day 1 to Week 26
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
2.4%
1/41 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.00%
0/133 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.83%
1/120 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/133 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
General disorders
Device dislocation
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
2.4%
1/41 • Number of events 2 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.00%
0/133 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.83%
1/120 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/133 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.75%
1/133 • Number of events 1 • Day 1 to Week 26
|
0.79%
1/127 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.00%
0/133 • Day 1 to Week 26
|
0.79%
1/127 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
Infections and infestations
Bronchitis
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.75%
1/133 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
Infections and infestations
Cellulitis
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
2.4%
1/41 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.00%
0/133 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.00%
0/133 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.80%
1/125 • Number of events 1 • Day 1 to Week 26
|
|
Infections and infestations
Pneumonia
|
0.00%
0/41 • Day 1 to Week 26
|
2.3%
1/44 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.75%
1/133 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
2.4%
1/42 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.00%
0/133 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
2.4%
1/42 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.00%
0/133 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.75%
1/133 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.75%
1/133 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
2.4%
1/41 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.00%
0/133 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.75%
1/133 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.75%
1/133 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.75%
1/133 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.83%
1/120 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/133 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
2.4%
1/41 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.00%
0/133 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.83%
1/120 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/133 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.83%
1/120 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/133 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.00%
0/133 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.80%
1/125 • Number of events 1 • Day 1 to Week 26
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.00%
0/133 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.80%
1/125 • Number of events 1 • Day 1 to Week 26
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.83%
1/120 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/133 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.4%
1/41 • Number of events 1 • Day 1 to Week 26
|
4.5%
2/44 • Number of events 2 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
2.5%
3/120 • Number of events 4 • Day 1 to Week 26
|
6.0%
8/133 • Number of events 9 • Day 1 to Week 26
|
4.7%
6/127 • Number of events 6 • Day 1 to Week 26
|
3.2%
4/125 • Number of events 4 • Day 1 to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
2.4%
1/42 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.00%
0/133 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.00%
0/133 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.80%
1/125 • Number of events 1 • Day 1 to Week 26
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
2.4%
1/42 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/120 • Day 1 to Week 26
|
0.00%
0/133 • Day 1 to Week 26
|
0.00%
0/127 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
Other adverse events
| Measure |
ADVAIR DISKUS 250/50 mcg
n=41 participants at risk
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
ADVAIR DISKUS 500/50 mcg
n=44 participants at risk
Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FLOVENT HFA 110 mcg
n=42 participants at risk
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
|
FLOVENT HFA 220 mcg
n=41 participants at risk
Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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=120 participants at risk
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol 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=133 participants at risk
Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.
Albuterol/salbutamol 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=127 participants at risk
Participants 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 Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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=125 participants at risk
Participants 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 Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.
Albuterol/salbutamol 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%
0/41 • Day 1 to Week 26
|
6.8%
3/44 • Number of events 3 • Day 1 to Week 26
|
2.4%
1/42 • Number of events 1 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
2.5%
3/120 • Number of events 3 • Day 1 to Week 26
|
2.3%
3/133 • Number of events 4 • Day 1 to Week 26
|
2.4%
3/127 • Number of events 3 • Day 1 to Week 26
|
2.4%
3/125 • Number of events 3 • Day 1 to Week 26
|
|
Infections and infestations
Bronchitis
|
2.4%
1/41 • Number of events 1 • Day 1 to Week 26
|
2.3%
1/44 • Number of events 1 • Day 1 to Week 26
|
7.1%
3/42 • Number of events 3 • Day 1 to Week 26
|
2.4%
1/41 • Number of events 1 • Day 1 to Week 26
|
3.3%
4/120 • Number of events 4 • Day 1 to Week 26
|
4.5%
6/133 • Number of events 7 • Day 1 to Week 26
|
3.9%
5/127 • Number of events 7 • Day 1 to Week 26
|
4.0%
5/125 • Number of events 5 • Day 1 to Week 26
|
|
Infections and infestations
Influenza
|
4.9%
2/41 • Number of events 2 • Day 1 to Week 26
|
2.3%
1/44 • Number of events 1 • Day 1 to Week 26
|
4.8%
2/42 • Number of events 2 • Day 1 to Week 26
|
12.2%
5/41 • Number of events 6 • Day 1 to Week 26
|
5.8%
7/120 • Number of events 7 • Day 1 to Week 26
|
2.3%
3/133 • Number of events 3 • Day 1 to Week 26
|
7.9%
10/127 • Number of events 10 • Day 1 to Week 26
|
6.4%
8/125 • Number of events 8 • Day 1 to Week 26
|
|
Infections and infestations
Nasopharyngitis
|
9.8%
4/41 • Number of events 5 • Day 1 to Week 26
|
9.1%
4/44 • Number of events 6 • Day 1 to Week 26
|
16.7%
7/42 • Number of events 8 • Day 1 to Week 26
|
12.2%
5/41 • Number of events 6 • Day 1 to Week 26
|
12.5%
15/120 • Number of events 21 • Day 1 to Week 26
|
9.0%
12/133 • Number of events 13 • Day 1 to Week 26
|
13.4%
17/127 • Number of events 20 • Day 1 to Week 26
|
10.4%
13/125 • Number of events 19 • Day 1 to Week 26
|
|
Infections and infestations
Oral candidiasis
|
4.9%
2/41 • Number of events 3 • Day 1 to Week 26
|
11.4%
5/44 • Number of events 9 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
12.2%
5/41 • Number of events 5 • Day 1 to Week 26
|
4.2%
5/120 • Number of events 8 • Day 1 to Week 26
|
3.8%
5/133 • Number of events 5 • Day 1 to Week 26
|
4.7%
6/127 • Number of events 8 • Day 1 to Week 26
|
4.0%
5/125 • Number of events 5 • Day 1 to Week 26
|
|
Infections and infestations
Sinusitis
|
9.8%
4/41 • Number of events 4 • Day 1 to Week 26
|
18.2%
8/44 • Number of events 9 • Day 1 to Week 26
|
7.1%
3/42 • Number of events 5 • Day 1 to Week 26
|
7.3%
3/41 • Number of events 3 • Day 1 to Week 26
|
7.5%
9/120 • Number of events 12 • Day 1 to Week 26
|
10.5%
14/133 • Number of events 15 • Day 1 to Week 26
|
11.8%
15/127 • Number of events 16 • Day 1 to Week 26
|
4.8%
6/125 • Number of events 7 • Day 1 to Week 26
|
|
Infections and infestations
Upper respiratory tract infection
|
22.0%
9/41 • Number of events 11 • Day 1 to Week 26
|
13.6%
6/44 • Number of events 8 • Day 1 to Week 26
|
28.6%
12/42 • Number of events 13 • Day 1 to Week 26
|
19.5%
8/41 • Number of events 10 • Day 1 to Week 26
|
17.5%
21/120 • Number of events 27 • Day 1 to Week 26
|
18.0%
24/133 • Number of events 26 • Day 1 to Week 26
|
18.1%
23/127 • Number of events 36 • Day 1 to Week 26
|
13.6%
17/125 • Number of events 21 • Day 1 to Week 26
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.9%
2/41 • Number of events 2 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
7.3%
3/41 • Number of events 3 • Day 1 to Week 26
|
0.83%
1/120 • Number of events 1 • Day 1 to Week 26
|
2.3%
3/133 • Number of events 3 • Day 1 to Week 26
|
0.79%
1/127 • Number of events 1 • Day 1 to Week 26
|
0.80%
1/125 • Number of events 1 • Day 1 to Week 26
|
|
Nervous system disorders
Headache
|
9.8%
4/41 • Number of events 15 • Day 1 to Week 26
|
4.5%
2/44 • Number of events 4 • Day 1 to Week 26
|
4.8%
2/42 • Number of events 2 • Day 1 to Week 26
|
2.4%
1/41 • Number of events 2 • Day 1 to Week 26
|
7.5%
9/120 • Number of events 11 • Day 1 to Week 26
|
2.3%
3/133 • Number of events 3 • Day 1 to Week 26
|
3.9%
5/127 • Number of events 5 • Day 1 to Week 26
|
4.8%
6/125 • Number of events 13 • Day 1 to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.9%
2/41 • Number of events 2 • Day 1 to Week 26
|
2.3%
1/44 • Number of events 1 • Day 1 to Week 26
|
7.1%
3/42 • Number of events 3 • Day 1 to Week 26
|
9.8%
4/41 • Number of events 6 • Day 1 to Week 26
|
11.7%
14/120 • Number of events 17 • Day 1 to Week 26
|
6.0%
8/133 • Number of events 13 • Day 1 to Week 26
|
7.9%
10/127 • Number of events 10 • Day 1 to Week 26
|
10.4%
13/125 • Number of events 20 • Day 1 to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/41 • Day 1 to Week 26
|
9.1%
4/44 • Number of events 6 • Day 1 to Week 26
|
11.9%
5/42 • Number of events 6 • Day 1 to Week 26
|
2.4%
1/41 • Number of events 1 • Day 1 to Week 26
|
5.8%
7/120 • Number of events 8 • Day 1 to Week 26
|
6.8%
9/133 • Number of events 9 • Day 1 to Week 26
|
10.2%
13/127 • Number of events 14 • Day 1 to Week 26
|
4.8%
6/125 • Number of events 7 • Day 1 to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/41 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
7.1%
3/42 • Number of events 3 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
1.7%
2/120 • Number of events 2 • Day 1 to Week 26
|
0.75%
1/133 • Number of events 2 • Day 1 to Week 26
|
0.79%
1/127 • Number of events 2 • Day 1 to Week 26
|
0.00%
0/125 • Day 1 to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
7.3%
3/41 • Number of events 3 • Day 1 to Week 26
|
0.00%
0/44 • Day 1 to Week 26
|
0.00%
0/42 • Day 1 to Week 26
|
2.4%
1/41 • Number of events 1 • Day 1 to Week 26
|
5.8%
7/120 • Number of events 8 • Day 1 to Week 26
|
1.5%
2/133 • Number of events 3 • Day 1 to Week 26
|
0.79%
1/127 • Number of events 1 • Day 1 to Week 26
|
1.6%
2/125 • Number of events 3 • Day 1 to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
4.9%
2/41 • Number of events 3 • Day 1 to Week 26
|
2.3%
1/44 • Number of events 1 • Day 1 to Week 26
|
7.1%
3/42 • Number of events 4 • Day 1 to Week 26
|
0.00%
0/41 • Day 1 to Week 26
|
1.7%
2/120 • Number of events 2 • Day 1 to Week 26
|
1.5%
2/133 • Number of events 2 • Day 1 to Week 26
|
0.79%
1/127 • Number of events 1 • Day 1 to Week 26
|
2.4%
3/125 • Number of events 3 • Day 1 to Week 26
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 1-215-591-3000
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