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Trial record 100 of 318 for:    FLUTICASONE AND SALMETEROL

Long-Term Safety Study of Fluticasone Propionate (Fp) Multidose Dry Powder Inhaler (MDPI) and Fluticasone Propionate/Salmeterol (FS) MDPI in Patients With Persistent Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02175771
Recruitment Status : Completed
First Posted : June 26, 2014
Results First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Persistent Asthma
Interventions Drug: Fp MDPI
Drug: FS MDPI
Drug: FLOVENT HFA
Drug: ADVAIR DISKUS
Drug: albuterol/salbutamol HFA
Enrollment 758
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Enrolled Patients Fp MDPI 100 mcg FLOVENT HFA 110 mcg Fp MDPI 200 mcg FLOVENT HFA 220 mcg FS MDPI 100/12.5 mcg ADVAIR DISKUS 250/50 mcg FS MDPI 200/12.5 mcg ADVAIR DISKUS 500/50 mcg
Hide Arm/Group Description 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.

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.

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.

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.

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.

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.

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.

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.

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.

Period Title: Run-In Period (Pre-assignment)
Started 758 [1] 0 0 0 0 0 0 0 0
Completed 674 0 0 0 0 0 0 0 0
Not Completed 84 0 0 0 0 0 0 0 0
Reason Not Completed
Randomization criteria not met             23             0             0             0             0             0             0             0             0
Exclusion criteria met             20             0             0             0             0             0             0             0             0
Withdrawal by Subject             11             0             0             0             0             0             0             0             0
Adverse Event             9             0             0             0             0             0             0             0             0
Inclusion criteria not met             7             0             0             0             0             0             0             0             0
Lost to Follow-up             6             0             0             0             0             0             0             0             0
Not specified             8             0             0             0             0             0             0             0             0
[1]
Enrolled; two participants were enrolled but had no enrollment date in their records.
Period Title: Treatment Period
Started 0 127 42 126 41 120 41 133 44
Completed 0 111 35 113 36 110 36 116 38
Not Completed 0 16 7 13 5 10 5 17 6
Reason Not Completed
Adverse Event             0             2             1             1             1             3             2             0             1
Withdrawal by Subject             0             9             3             6             2             4             2             9             2
Noncompliance             0             1             2             0             0             0             0             0             1
Protocol Violation             0             0             0             0             0             0             0             1             0
Disease progression             0             0             0             0             0             0             0             2             0
Lost to Follow-up             0             3             1             3             1             2             1             2             2
Lack of Efficacy             0             0             0             0             0             1             0             1             0
Not specified             0             1             0             3             1             0             0             2             0
Arm/Group Title Fp MDPI 100 mcg FLOVENT HFA 110 mcg Fp MDPI 200 mcg FLOVENT HFA 220 mcg FS MDPI 100/12.5 mcg ADVAIR DISKUS 250/50 mcg FS MDPI 200/12.5 mcg ADVAIR DISKUS 500/50 mcg Total
Hide Arm/Group Description

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.

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.

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.

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.

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.

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 127 42 126 41 120 41 133 44 674
Hide Baseline Analysis Population Description
Safety population which included all randomized participants who received at least 1 dose of randomized study drug
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 42 participants 126 participants 41 participants 120 participants 41 participants 133 participants 44 participants 674 participants
Adolescents (12-17 years)
19
  15.0%
7
  16.7%
16
  12.7%
3
   7.3%
13
  10.8%
5
  12.2%
9
   6.8%
1
   2.3%
73
  10.8%
Adults (18-64 years)
96
  75.6%
32
  76.2%
96
  76.2%
35
  85.4%
94
  78.3%
31
  75.6%
106
  79.7%
41
  93.2%
531
  78.8%
Adults (65+ years)
12
   9.4%
3
   7.1%
12
   9.5%
3
   7.3%
13
  10.8%
5
  12.2%
18
  13.5%
2
   4.5%
68
  10.1%
Missing
0
   0.0%
0
   0.0%
2
   1.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.3%
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 42 participants 126 participants 41 participants 120 participants 41 participants 133 participants 44 participants 674 participants
Male
49
  38.6%
16
  38.1%
46
  36.5%
16
  39.0%
36
  30.0%
21
  51.2%
61
  45.9%
21
  47.7%
266
  39.5%
Female
78
  61.4%
26
  61.9%
78
  61.9%
25
  61.0%
84
  70.0%
20
  48.8%
72
  54.1%
23
  52.3%
406
  60.2%
Missing
0
   0.0%
0
   0.0%
2
   1.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 42 participants 126 participants 41 participants 120 participants 41 participants 133 participants 44 participants 674 participants
Not Hispanic or Latino
118
  92.9%
39
  92.9%
100
  79.4%
33
  80.5%
99
  82.5%
36
  87.8%
112
  84.2%
39
  88.6%
576
  85.5%
Hispanic or Latino
9
   7.1%
3
   7.1%
24
  19.0%
8
  19.5%
21
  17.5%
5
  12.2%
20
  15.0%
5
  11.4%
95
  14.1%
Unknown
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
0
   0.0%
1
   0.1%
Missing
0
   0.0%
0
   0.0%
2
   1.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 42 participants 126 participants 41 participants 120 participants 41 participants 133 participants 44 participants 674 participants
White
110
  86.6%
26
  61.9%
99
  78.6%
36
  87.8%
99
  82.5%
32
  78.0%
95
  71.4%
31
  70.5%
528
  78.3%
Black or African American
16
  12.6%
13
  31.0%
22
  17.5%
5
  12.2%
19
  15.8%
9
  22.0%
31
  23.3%
12
  27.3%
127
  18.8%
Asian
1
   0.8%
1
   2.4%
1
   0.8%
0
   0.0%
2
   1.7%
0
   0.0%
4
   3.0%
0
   0.0%
9
   1.3%
American Indian or Alaskan Native
0
   0.0%
1
   2.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   1.5%
0
   0.0%
3
   0.4%
Pacific Islander
0
   0.0%
0
   0.0%
2
   1.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
3
   0.4%
Other
0
   0.0%
1
   2.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
0
   0.0%
2
   0.3%
Missing
0
   0.0%
0
   0.0%
2
   1.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.3%
History of Smoking  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 42 participants 126 participants 41 participants 120 participants 41 participants 133 participants 44 participants 674 participants
Prior smoker
26
  20.5%
10
  23.8%
20
  15.9%
5
  12.2%
23
  19.2%
7
  17.1%
24
  18.0%
8
  18.2%
123
  18.2%
No tobacco use
101
  79.5%
32
  76.2%
106
  84.1%
36
  87.8%
97
  80.8%
34
  82.9%
109
  82.0%
36
  81.8%
551
  81.8%
1.Primary Outcome
Title Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
Hide Description 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.
Time Frame Day 1 to Week 26 of the Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description

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

Arm/Group Title Fp MDPI 100 mcg FLOVENT HFA 110 mcg Fp MDPI 200 mcg FLOVENT HFA 220 mcg FS MDPI 100/12.5 mcg ADVAIR DISKUS 250/50 mcg FS MDPI 200/12.5 mcg ADVAIR DISKUS 500/50 mcg
Hide Arm/Group Description:

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.

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.

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.

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.

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.

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.

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.

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.

Overall Number of Participants Analyzed 127 42 125 41 120 41 133 44
Measure Type: Count of Participants
Unit of Measure: Participants
>=1 TEAE
85
  66.9%
29
  69.0%
83
  66.4%
29
  70.7%
92
  76.7%
29
  70.7%
86
  64.7%
30
  68.2%
>=1 severe TEAE
8
   6.3%
3
   7.1%
11
   8.8%
3
   7.3%
8
   6.7%
1
   2.4%
12
   9.0%
3
   6.8%
>=1 treatment-related TEAE
10
   7.9%
2
   4.8%
6
   4.8%
5
  12.2%
9
   7.5%
4
   9.8%
11
   8.3%
8
  18.2%
>=1 severe treatment-related TEAE
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=1 serious TEAE
7
   5.5%
2
   4.8%
8
   6.4%
3
   7.3%
6
   5.0%
2
   4.9%
13
   9.8%
3
   6.8%
>=1 TEAE leading to withdrawal
2
   1.6%
1
   2.4%
0
   0.0%
1
   2.4%
3
   2.5%
2
   4.9%
0
   0.0%
1
   2.3%
>=1 nonserious TEAE
85
  66.9%
27
  64.3%
82
  65.6%
29
  70.7%
91
  75.8%
28
  68.3%
85
  63.9%
29
  65.9%
>=1 TEAE resulting in death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Participants With Positive Swab Test Results for Oral Candidiasis
Hide Description

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.

Time Frame Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, Endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Fp MDPI 100 mcg FLOVENT HFA 110 mcg Fp MDPI 200 mcg FLOVENT HFA 220 mcg FS MDPI 100/12.5 mcg ADVAIR DISKUS 250/50 mcg FS MDPI 200/12.5 mcg ADVAIR DISKUS 500/50 mcg
Hide Arm/Group Description:

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.

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.

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.

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.

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.

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.

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.

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.

Overall Number of Participants Analyzed 127 42 125 41 120 41 133 44
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline (n=127, 42, 124, 41, 120, 41, 133, 44)
2
   1.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 2 (n=123, 42, 123, 40, 117, 39, 131, 43)
2
   1.6%
0
   0.0%
1
   0.8%
0
   0.0%
1
   0.8%
0
   0.0%
1
   0.8%
2
   4.5%
Week 6 (n=119, 41, 119, 40, 115, 39, 125, 43)
1
   0.8%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
2
   4.9%
1
   0.8%
0
   0.0%
Week 10 (n=119, 37, 118, 39, 115, 39, 120, 40)
0
   0.0%
0
   0.0%
1
   0.8%
1
   2.4%
1
   0.8%
1
   2.4%
0
   0.0%
1
   2.3%
Week 14 (n=116, 36, 115, 38, 113, 38, 120, 41)
1
   0.8%
0
   0.0%
1
   0.8%
1
   2.4%
2
   1.7%
0
   0.0%
1
   0.8%
1
   2.3%
Week 18 (n=111, 37, 115, 38, 109, 38, 117, 40)
1
   0.8%
0
   0.0%
1
   0.8%
1
   2.4%
0
   0.0%
1
   2.4%
0
   0.0%
0
   0.0%
Week 22 (n=110, 36, 113, 36, 110, 37, 116, 38)
1
   0.8%
0
   0.0%
1
   0.8%
1
   2.4%
1
   0.8%
0
   0.0%
2
   1.5%
2
   4.5%
Week 26 (n=111, 35, 113, 36, 110, 36, 116, 38)
1
   0.8%
0
   0.0%
1
   0.8%
1
   2.4%
0
   0.0%
1
   2.4%
0
   0.0%
0
   0.0%
Endpoint (n=125, 42, 123, 41, 119, 40, 132, 44)
1
   0.8%
0
   0.0%
1
   0.8%
1
   2.4%
0
   0.0%
1
   2.4%
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period
Hide Description

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
Time Frame Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, Endpoint
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population of participants with a baseline and postbaseline vital sign value.
Arm/Group Title Fp MDPI 100 mcg FLOVENT HFA 110 mcg Fp MDPI 200 mcg FLOVENT HFA 220 mcg FS MDPI 100/12.5 mcg ADVAIR DISKUS 250/50 mcg FS MDPI 200/12.5 mcg ADVAIR DISKUS 500/50 mcg
Hide Arm/Group Description:

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.

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.

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.

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.

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.

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.

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.

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.

Overall Number of Participants Analyzed 125 42 123 41 119 40 132 44
Measure Type: Count of Participants
Unit of Measure: Participants
>=1 abnormality
5
   4.0%
0
   0.0%
0
   0.0%
1
   2.4%
2
   1.7%
0
   0.0%
2
   1.5%
0
   0.0%
Systolic blood pressure - high
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Systolic blood pressure - low
1
   0.8%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
0
   0.0%
0
   0.0%
0
   0.0%
Diastolic blood pressure - high
1
   0.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
0
   0.0%
Diastolic blood pressure - low
1
   0.8%
0
   0.0%
0
   0.0%
1
   2.4%
1
   0.8%
0
   0.0%
1
   0.8%
0
   0.0%
Pulse - high
1
   0.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Pulse - low
1
   0.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings
Hide Description 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.
Time Frame Screening (Day -14), Endpoint (week 26 if study was completed)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population of participants with both screening and endpoint ECGs
Arm/Group Title Fp MDPI 100 mcg FLOVENT HFA 110 mcg Fp MDPI 200 mcg FLOVENT HFA 220 mcg FS MDPI 100/12.5 mcg ADVAIR DISKUS 250/50 mcg FS MDPI 200/12.5 mcg ADVAIR DISKUS 500/50 mcg
Hide Arm/Group Description:

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.

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.

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.

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.

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.

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.

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.

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.

Overall Number of Participants Analyzed 112 39 116 39 116 38 125 39
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline normal - Endpoint normal
89
  79.5%
31
  79.5%
93
  80.2%
33
  84.6%
90
  77.6%
30
  78.9%
101
  80.8%
28
  71.8%
Baseline normal - Endpoint abnormal
8
   7.1%
5
  12.8%
6
   5.2%
1
   2.6%
9
   7.8%
2
   5.3%
8
   6.4%
3
   7.7%
Baseline abnormal - Endpoint normal
4
   3.6%
1
   2.6%
4
   3.4%
2
   5.1%
12
  10.3%
2
   5.3%
9
   7.2%
4
  10.3%
Baseline abnormal - Endpoint abnormal
11
   9.8%
2
   5.1%
13
  11.2%
3
   7.7%
5
   4.3%
4
  10.5%
7
   5.6%
4
  10.3%
5.Secondary Outcome
Title Analysis of 24-Hour Urine Cortisol Free Over the 26-Week Treatment Period
Hide Description

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.

Time Frame Baseline (Day 1, pre-treatment), Weeks 14 and 26 and early termination visit if applicable
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fp MDPI 100 mcg FLOVENT HFA 110 mcg Fp MDPI 200 mcg FLOVENT HFA 220 mcg FS MDPI 100/12.5 mcg ADVAIR DISKUS 250/50 mcg FS MDPI 200/12.5 mcg ADVAIR DISKUS 500/50 mcg
Hide Arm/Group Description:

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.

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.

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.

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.

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.

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.

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.

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.

Overall Number of Participants Analyzed 80 28 93 28 87 29 91 38
Geometric Mean (95% Confidence Interval)
Unit of Measure: mcg/24 hours
18.45
(15.77 to 21.58)
13.94
(10.67 to 18.22)
14.14
(12.23 to 16.34)
17.50
(13.40 to 22.85)
17.56
(15.13 to 20.38)
18.29
(14.07 to 23.77)
13.02
(11.23 to 15.09)
15.42
(12.27 to 19.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fp MDPI 100 mcg, FLOVENT HFA 110 mcg
Comments Mid-strength comparison
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean ratio
Estimated Value 1.32
Confidence Interval (2-Sided) 90%
1.02 to 1.72
Estimation Comments Fp MDPI / FLOVENT HFA
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fp MDPI 200 mcg, FLOVENT HFA 220 mcg
Comments High-strength comparison
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean ratio
Estimated Value 0.81
Confidence Interval (2-Sided) 90%
0.63 to 1.04
Estimation Comments Fp MDPI / FLOVENT HFA
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection FS MDPI 100/12.5 mcg, ADVAIR DISKUS 250/50 mcg
Comments Mid-strength comparison
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean ratio
Estimated Value 0.96
Confidence Interval (2-Sided) 90%
0.75 to 1.24
Estimation Comments FS MDPI / ADVAIR DISKUS
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection FS MDPI 200/12.5 mcg, ADVAIR DISKUS 500/50 mcg
Comments High-strength comparison
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean ratio
Estimated Value 0.84
Confidence Interval (2-Sided) 90%
0.67 to 1.06
Estimation Comments FS MDPI / ADVAIR DISKUS
6.Secondary Outcome
Title Change From Baseline in Trough Forced Expiratory Volume in 1 Minute (FEV1) Over the 26-Week Treatment Period
Hide Description

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.

Time Frame Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, early termination visit if applicable
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fp MDPI 100 mcg FLOVENT HFA 110 mcg Fp MDPI 200 mcg FLOVENT HFA 220 mcg FS MDPI 100/12.5 mcg ADVAIR DISKUS 250/50 mcg FS MDPI 200/12.5 mcg ADVAIR DISKUS 500/50 mcg
Hide Arm/Group Description:

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.

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.

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.

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.

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.

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.

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.

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.

Overall Number of Participants Analyzed 123 42 120 41 119 40 130 44
Least Squares Mean (Standard Error)
Unit of Measure: liters
0.062  (0.0243) 0.053  (0.0415) 0.077  (0.0246) 0.090  (0.0415) 0.116  (0.0251) 0.117  (0.0419) 0.100  (0.0235) 0.041  (0.0399)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fp MDPI 100 mcg, FLOVENT HFA 110 mcg
Comments Mid-strength comparison
Type of Statistical Test Non-Inferiority
Comments The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than –125 mL.
Statistical Test of Hypothesis P-Value 0.8451
Comments [Not Specified]
Method mixed model for repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM difference
Estimated Value 0.009
Confidence Interval (2-Sided) 95%
-0.084 to 0.103
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0476
Estimation Comments Fp MDPI / FLOVENT HFA
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fp MDPI 200 mcg, FLOVENT HFA 220 mcg
Comments High-strength comparison
Type of Statistical Test Non-Inferiority
Comments The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than –125 mL.
Statistical Test of Hypothesis P-Value 0.7877
Comments [Not Specified]
Method mixed model for repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM difference
Estimated Value -0.013
Confidence Interval (2-Sided) 95%
-0.107 to 0.081
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0479
Estimation Comments Fp MDPI / FLOVENT HFA
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection FS MDPI 100/12.5 mcg, ADVAIR DISKUS 250/50 mcg
Comments Mid-strength comparison
Type of Statistical Test Non-Inferiority
Comments The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than –125 mL.
Statistical Test of Hypothesis P-Value 0.9966
Comments [Not Specified]
Method mixed model for repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM difference
Estimated Value 0.000
Confidence Interval (2-Sided) 95%
-0.095 to 0.095
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0485
Estimation Comments FS MDPI / ADVAIR DISKUS
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection FS MDPI 200/12.5 mcg, ADVAIR DISKUS 500/50 mcg
Comments High-strength comparison
Type of Statistical Test Non-Inferiority
Comments The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than –125 mL.
Statistical Test of Hypothesis P-Value 0.2056
Comments [Not Specified]
Method mixed model for repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter LSM difference
Estimated Value 0.059
Confidence Interval (2-Sided) 95%
-0.032 to 0.150
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.0464
Estimation Comments FS MDPI / ADVAIR DISKUS
Time Frame Day 1 to Week 26
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ADVAIR DISKUS 250/50 mcg ADVAIR DISKUS 500/50 mcg FLOVENT HFA 110 mcg FLOVENT HFA 220 mcg FS MDPI 100/12.5 mcg FS MDPI 200/12.5 mcg Fp MDPI 100 mcg Fp MDPI 200 mcg
Hide Arm/Group Description

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.

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 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.

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.

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.

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.

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.

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.

All-Cause Mortality
ADVAIR DISKUS 250/50 mcg ADVAIR DISKUS 500/50 mcg FLOVENT HFA 110 mcg FLOVENT HFA 220 mcg FS MDPI 100/12.5 mcg FS MDPI 200/12.5 mcg Fp MDPI 100 mcg Fp MDPI 200 mcg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)      0/44 (0.00%)      0/42 (0.00%)      0/41 (0.00%)      0/120 (0.00%)      0/133 (0.00%)      0/127 (0.00%)      0/125 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
ADVAIR DISKUS 250/50 mcg ADVAIR DISKUS 500/50 mcg FLOVENT HFA 110 mcg FLOVENT HFA 220 mcg FS MDPI 100/12.5 mcg FS MDPI 200/12.5 mcg Fp MDPI 100 mcg Fp MDPI 200 mcg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/41 (4.88%)      3/44 (6.82%)      2/42 (4.76%)      3/41 (7.32%)      6/120 (5.00%)      13/133 (9.77%)      7/127 (5.51%)      8/125 (6.40%)    
Cardiac disorders                 
Acute myocardial infarction  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 0/41 (0.00%)  0 0/120 (0.00%)  0 0/133 (0.00%)  0 0/127 (0.00%)  0 1/125 (0.80%)  1
Atrial tachycardia  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 1/41 (2.44%)  1 0/120 (0.00%)  0 0/133 (0.00%)  0 0/127 (0.00%)  0 0/125 (0.00%)  0
Gastrointestinal disorders                 
Faecaloma  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 0/41 (0.00%)  0 1/120 (0.83%)  1 0/133 (0.00%)  0 0/127 (0.00%)  0 0/125 (0.00%)  0
General disorders                 
Device dislocation  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 1/41 (2.44%)  2 0/120 (0.00%)  0 0/133 (0.00%)  0 0/127 (0.00%)  0 0/125 (0.00%)  0
Non-cardiac chest pain  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 0/41 (0.00%)  0 1/120 (0.83%)  1 0/133 (0.00%)  0 0/127 (0.00%)  0 0/125 (0.00%)  0
Hepatobiliary disorders                 
Biliary colic  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 0/41 (0.00%)  0 0/120 (0.00%)  0 1/133 (0.75%)  1 1/127 (0.79%)  1 0/125 (0.00%)  0
Cholelithiasis  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 0/41 (0.00%)  0 0/120 (0.00%)  0 0/133 (0.00%)  0 1/127 (0.79%)  1 0/125 (0.00%)  0
Infections and infestations                 
Bronchitis  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 0/41 (0.00%)  0 0/120 (0.00%)  0 1/133 (0.75%)  1 0/127 (0.00%)  0 0/125 (0.00%)  0
Cellulitis  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 1/41 (2.44%)  1 0/120 (0.00%)  0 0/133 (0.00%)  0 0/127 (0.00%)  0 0/125 (0.00%)  0
Lobar pneumonia  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 0/41 (0.00%)  0 0/120 (0.00%)  0 0/133 (0.00%)  0 0/127 (0.00%)  0 1/125 (0.80%)  1
Pneumonia  1  0/41 (0.00%)  0 1/44 (2.27%)  1 0/42 (0.00%)  0 0/41 (0.00%)  0 0/120 (0.00%)  0 1/133 (0.75%)  1 0/127 (0.00%)  0 0/125 (0.00%)  0
Injury, poisoning and procedural complications                 
Fall  1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  1 0/41 (0.00%)  0 0/120 (0.00%)  0 0/133 (0.00%)  0 0/127 (0.00%)  0 0/125 (0.00%)  0
Hip fracture  1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  1 0/41 (0.00%)  0 0/120 (0.00%)  0 0/133 (0.00%)  0 0/127 (0.00%)  0 0/125 (0.00%)  0
Humerus fracture  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 0/41 (0.00%)  0 0/120 (0.00%)  0 1/133 (0.75%)  1 0/127 (0.00%)  0 0/125 (0.00%)  0
Procedural pain  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 0/41 (0.00%)  0 0/120 (0.00%)  0 1/133 (0.75%)  1 0/127 (0.00%)  0 0/125 (0.00%)  0
Wound dehiscence  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 1/41 (2.44%)  1 0/120 (0.00%)  0 0/133 (0.00%)  0 0/127 (0.00%)  0 0/125 (0.00%)  0
Metabolism and nutrition disorders                 
Hyperglycaemia  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 0/41 (0.00%)  0 0/120 (0.00%)  0 1/133 (0.75%)  1 0/127 (0.00%)  0 0/125 (0.00%)  0
Musculoskeletal and connective tissue disorders                 
Arthritis  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 0/41 (0.00%)  0 0/120 (0.00%)  0 1/133 (0.75%)  1 0/127 (0.00%)  0 0/125 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Basal cell carcinoma  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 0/41 (0.00%)  0 0/120 (0.00%)  0 1/133 (0.75%)  1 0/127 (0.00%)  0 0/125 (0.00%)  0
Leiomyoma  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 0/41 (0.00%)  0 1/120 (0.83%)  1 0/133 (0.00%)  0 0/127 (0.00%)  0 0/125 (0.00%)  0
Malignant melanoma  1  1/41 (2.44%)  1 0/44 (0.00%)  0 0/42 (0.00%)  0 0/41 (0.00%)  0 0/120 (0.00%)  0 0/133 (0.00%)  0 0/127 (0.00%)  0 0/125 (0.00%)  0
Non-small cell lung cancer  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 0/41 (0.00%)  0 1/120 (0.83%)  1 0/133 (0.00%)  0 0/127 (0.00%)  0 0/125 (0.00%)  0
Uterine leiomyoma  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 0/41 (0.00%)  0 1/120 (0.83%)  1 0/133 (0.00%)  0 0/127 (0.00%)  0 0/125 (0.00%)  0
Pregnancy, puerperium and perinatal conditions                 
Abortion spontaneous  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 0/41 (0.00%)  0 0/120 (0.00%)  0 0/133 (0.00%)  0 0/127 (0.00%)  0 1/125 (0.80%)  1
Ectopic pregnancy  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 0/41 (0.00%)  0 0/120 (0.00%)  0 0/133 (0.00%)  0 0/127 (0.00%)  0 1/125 (0.80%)  1
Reproductive system and breast disorders                 
Adenomyosis  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 0/41 (0.00%)  0 1/120 (0.83%)  1 0/133 (0.00%)  0 0/127 (0.00%)  0 0/125 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
Asthma  1  1/41 (2.44%)  1 2/44 (4.55%)  2 0/42 (0.00%)  0 0/41 (0.00%)  0 3/120 (2.50%)  4 8/133 (6.02%)  9 6/127 (4.72%)  6 4/125 (3.20%)  4
Pulmonary embolism  1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  1 0/41 (0.00%)  0 0/120 (0.00%)  0 0/133 (0.00%)  0 0/127 (0.00%)  0 0/125 (0.00%)  0
Pulmonary mass  1  0/41 (0.00%)  0 0/44 (0.00%)  0 0/42 (0.00%)  0 0/41 (0.00%)  0 0/120 (0.00%)  0 0/133 (0.00%)  0 0/127 (0.00%)  0 1/125 (0.80%)  1
Vascular disorders                 
Deep vein thrombosis  1  0/41 (0.00%)  0 0/44 (0.00%)  0 1/42 (2.38%)  1 0/41 (0.00%)  0 0/120 (0.00%)  0 0/133 (0.00%)  0 0/127 (0.00%)  0 0/125 (0.00%)  0
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ADVAIR DISKUS 250/50 mcg ADVAIR DISKUS 500/50 mcg FLOVENT HFA 110 mcg FLOVENT HFA 220 mcg FS MDPI 100/12.5 mcg FS MDPI 200/12.5 mcg Fp MDPI 100 mcg Fp MDPI 200 mcg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/41 (53.66%)      23/44 (52.27%)      24/42 (57.14%)      25/41 (60.98%)      70/120 (58.33%)      68/133 (51.13%)      65/127 (51.18%)      55/125 (44.00%)    
General disorders                 
Pyrexia  1  0/41 (0.00%)  0 3/44 (6.82%)  3 1/42 (2.38%)  1 0/41 (0.00%)  0 3/120 (2.50%)  3 3/133 (2.26%)  4 3/127 (2.36%)  3 3/125 (2.40%)  3
Infections and infestations                 
Bronchitis  1  1/41 (2.44%)  1 1/44 (2.27%)  1 3/42 (7.14%)  3 1/41 (2.44%)  1 4/120 (3.33%)  4 6/133 (4.51%)  7 5/127 (3.94%)  7 5/125 (4.00%)  5
Influenza  1  2/41 (4.88%)  2 1/44 (2.27%)  1 2/42 (4.76%)  2 5/41 (12.20%)  6 7/120 (5.83%)  7 3/133 (2.26%)  3 10/127 (7.87%)  10 8/125 (6.40%)  8
Nasopharyngitis  1  4/41 (9.76%)  5 4/44 (9.09%)  6 7/42 (16.67%)  8 5/41 (12.20%)  6 15/120 (12.50%)  21 12/133 (9.02%)  13 17/127 (13.39%)  20 13/125 (10.40%)  19
Oral candidiasis  1  2/41 (4.88%)  3 5/44 (11.36%)  9 0/42 (0.00%)  0 5/41 (12.20%)  5 5/120 (4.17%)  8 5/133 (3.76%)  5 6/127 (4.72%)  8 5/125 (4.00%)  5
Sinusitis  1  4/41 (9.76%)  4 8/44 (18.18%)  9 3/42 (7.14%)  5 3/41 (7.32%)  3 9/120 (7.50%)  12 14/133 (10.53%)  15 15/127 (11.81%)  16 6/125 (4.80%)  7
Upper respiratory tract infection  1  9/41 (21.95%)  11 6/44 (13.64%)  8 12/42 (28.57%)  13 8/41 (19.51%)  10 21/120 (17.50%)  27 24/133 (18.05%)  26 23/127 (18.11%)  36 17/125 (13.60%)  21
Musculoskeletal and connective tissue disorders                 
Back pain  1  2/41 (4.88%)  2 0/44 (0.00%)  0 0/42 (0.00%)  0 3/41 (7.32%)  3 1/120 (0.83%)  1 3/133 (2.26%)  3 1/127 (0.79%)  1 1/125 (0.80%)  1
Nervous system disorders                 
Headache  1  4/41 (9.76%)  15 2/44 (4.55%)  4 2/42 (4.76%)  2 1/41 (2.44%)  2 9/120 (7.50%)  11 3/133 (2.26%)  3 5/127 (3.94%)  5 6/125 (4.80%)  13
Respiratory, thoracic and mediastinal disorders                 
Cough  1  2/41 (4.88%)  2 1/44 (2.27%)  1 3/42 (7.14%)  3 4/41 (9.76%)  6 14/120 (11.67%)  17 8/133 (6.02%)  13 10/127 (7.87%)  10 13/125 (10.40%)  20
Oropharyngeal pain  1  0/41 (0.00%)  0 4/44 (9.09%)  6 5/42 (11.90%)  6 1/41 (2.44%)  1 7/120 (5.83%)  8 9/133 (6.77%)  9 13/127 (10.24%)  14 6/125 (4.80%)  7
Respiratory tract congestion  1  0/41 (0.00%)  0 0/44 (0.00%)  0 3/42 (7.14%)  3 0/41 (0.00%)  0 2/120 (1.67%)  2 1/133 (0.75%)  2 1/127 (0.79%)  2 0/125 (0.00%)  0
Rhinitis allergic  1  3/41 (7.32%)  3 0/44 (0.00%)  0 0/42 (0.00%)  0 1/41 (2.44%)  1 7/120 (5.83%)  8 2/133 (1.50%)  3 1/127 (0.79%)  1 2/125 (1.60%)  3
Sinus congestion  1  2/41 (4.88%)  3 1/44 (2.27%)  1 3/42 (7.14%)  4 0/41 (0.00%)  0 2/120 (1.67%)  2 2/133 (1.50%)  2 1/127 (0.79%)  1 3/125 (2.40%)  3
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 1-215-591-3000
EMail: ustevatrials@tevapharm.com
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT02175771     History of Changes
Other Study ID Numbers: FSS-AS-305
First Submitted: June 24, 2014
First Posted: June 26, 2014
Results First Submitted: March 2, 2017
Results First Posted: April 14, 2017
Last Update Posted: April 14, 2017