Trial Outcomes & Findings for Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily (NCT NCT01147744)
NCT ID: NCT01147744
Last Updated: 2017-10-02
Results Overview
Pulmonary function was measured by forced expiratory volume in one second, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the morning (AM) pre-dose and pre-rescue bronchodilator FEV1 at the clinic visit. Baseline was the pre-dose value obtained at Visit 3. Change from Baseline was calculated as the end of Week 8 value minus the Baseline value. Analysis of covariance (ANCOVA) model used for statistical analysis. ITT Population was comprised of all participant randomized to treatment who received at least one dose of double-blind study medication.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
700 participants
Primary outcome timeframe
Baseline and Week 8
Results posted on
2017-10-02
Participant Flow
A total of 1245 participants were screened, of these, 363 participants failed screening, 882 entered the run-in phase and a total of 700 participants were randomized and included in Intent to Treat (ITT) Population . The study was conducted from 28 Jun 2010 to 06 October 2011, in the Ukraine, United States, Bulgaria, Poland, Japan, Romania.
Participants were screened (Visit 1) for eligibility, which included reversibility testing. Following screening and a 14-days Run-in Period, participants who met the eligibility criteria for randomization to study treatment at Visit 3 were randomly assigned to receive one of seven double-blind treatments for 8 weeks.
Participant milestones
| Measure |
Placebo
Participants received two tablets of placebo orally plus one dose of fluticasone propionate (FP) matching placebo twice daily (BID) via dry powder inhaler (DPI) in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally once daily (QD) in evening for the 8-Weeks.
|
GSK2190915 10 Milligrams (mg)
Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 30mg
Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 100mg
Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 300mg
Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Fluticasone Propionate 100 Microgram (mcg)
Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Montelukast 10mg
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
100
|
99
|
100
|
100
|
101
|
103
|
97
|
|
Overall Study
COMPLETED
|
71
|
76
|
82
|
82
|
76
|
83
|
78
|
|
Overall Study
NOT COMPLETED
|
29
|
23
|
18
|
18
|
25
|
20
|
19
|
Reasons for withdrawal
| Measure |
Placebo
Participants received two tablets of placebo orally plus one dose of fluticasone propionate (FP) matching placebo twice daily (BID) via dry powder inhaler (DPI) in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally once daily (QD) in evening for the 8-Weeks.
|
GSK2190915 10 Milligrams (mg)
Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 30mg
Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 100mg
Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 300mg
Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Fluticasone Propionate 100 Microgram (mcg)
Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Montelukast 10mg
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
0
|
1
|
3
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
11
|
11
|
9
|
11
|
13
|
8
|
7
|
|
Overall Study
Adverse Event
|
1
|
2
|
3
|
0
|
2
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
8
|
4
|
2
|
2
|
2
|
5
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Sponsor decision to amend protocol
|
7
|
4
|
2
|
5
|
7
|
2
|
6
|
|
Overall Study
Met Protocol-defined Stopping Criteria
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily
Baseline characteristics by cohort
| Measure |
Placebo
n=100 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 10 mg
n=99 Participants
Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 30 mg
n=100 Participants
Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 100 mg
n=100 Participants
Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 300 mg
n=101 Participants
Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Fluticasone Propionate 100 mcg
n=103 Participants
Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Montelukast 10 mg
n=97 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
|
Total
n=700 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.3 Years
STANDARD_DEVIATION 16.13 • n=93 Participants
|
40 Years
STANDARD_DEVIATION 15.56 • n=4 Participants
|
43.1 Years
STANDARD_DEVIATION 16.17 • n=27 Participants
|
42.2 Years
STANDARD_DEVIATION 14.63 • n=483 Participants
|
42.2 Years
STANDARD_DEVIATION 14.15 • n=36 Participants
|
41.5 Years
STANDARD_DEVIATION 15.16 • n=10 Participants
|
44.3 Years
STANDARD_DEVIATION 14.97 • n=115 Participants
|
42.2 Years
STANDARD_DEVIATION 15.25 • n=40 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=93 Participants
|
91 Participants
n=4 Participants
|
94 Participants
n=27 Participants
|
92 Participants
n=483 Participants
|
93 Participants
n=36 Participants
|
97 Participants
n=10 Participants
|
89 Participants
n=115 Participants
|
644 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
56 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
85 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
62 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=93 Participants
|
74 Participants
n=4 Participants
|
78 Participants
n=27 Participants
|
78 Participants
n=483 Participants
|
78 Participants
n=36 Participants
|
83 Participants
n=10 Participants
|
76 Participants
n=115 Participants
|
549 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: ITT population. When possible, data from participants who withdrew prematurely from the study were included in the analyses. Any evaluable subject whose FEV1 measurement at Week 8 was missing was included in the analysis by imputation, using the preceding non-missing FEV1 value (last observation carried forward \[LOCF\]).
Pulmonary function was measured by forced expiratory volume in one second, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the morning (AM) pre-dose and pre-rescue bronchodilator FEV1 at the clinic visit. Baseline was the pre-dose value obtained at Visit 3. Change from Baseline was calculated as the end of Week 8 value minus the Baseline value. Analysis of covariance (ANCOVA) model used for statistical analysis. ITT Population was comprised of all participant randomized to treatment who received at least one dose of double-blind study medication.
Outcome measures
| Measure |
Placebo
n=98 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 10 mg
n=96 Participants
Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 30 mg
n=99 Participants
Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 100 mg
n=100 Participants
Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 300 mg
n=98 Participants
Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Fluticasone Propionate 100 mcg
n=100 Participants
Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Montelukast 10 mg
n=95 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1)
|
0.12 Liters
Standard Error 0.04
|
0.18 Liters
Standard Error 0.04
|
0.23 Liters
Standard Error 0.04
|
0.19 Liters
Standard Error 0.04
|
0.19 Liters
Standard Error 0.04
|
0.31 Liters
Standard Error 0.04
|
0.19 Liters
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline up to Week 8Population: ITT Population. Only those participants with analyzable data at the indicated time point were assessed.
Peak expiratory flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Change from Baseline was calculated as the value of the averaged PEF daily (pre-dose and pre-rescue bronchodilator) evening over the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants)
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 10 mg
n=99 Participants
Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 30 mg
n=99 Participants
Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 100 mg
n=100 Participants
Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 300 mg
n=101 Participants
Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Fluticasone Propionate 100 mcg
n=101 Participants
Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Montelukast 10 mg
n=97 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period
|
8.01 Liters per minute
Standard Error 3.19
|
7.62 Liters per minute
Standard Error 3.19
|
9.37 Liters per minute
Standard Error 3.20
|
6.21 Liters per minute
Standard Error 3.17
|
10.33 Liters per minute
Standard Error 3.15
|
10.46 Liters per minute
Standard Error 3.16
|
8.53 Liters per minute
Standard Error 3.24
|
SECONDARY outcome
Timeframe: Baseline up to Week 8Population: ITT Population. Only those participants with analyzable data at the indicated time point were assessed.
The PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough AM PEF is defined as the AM pre-dose and pre-rescue bronchodilator at the clinic visit. Change from Baseline was calculated as the value of the averaged PEF daily (pre-dose and pre-rescue bronchodilator) AM over the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 10 mg
n=99 Participants
Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 30 mg
n=99 Participants
Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 100 mg
n=100 Participants
Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 300 mg
n=101 Participants
Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Fluticasone Propionate 100 mcg
n=100 Participants
Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Montelukast 10 mg
n=97 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Daily Trough AM PEF Averaged Over the 8-Week Treatment Period
|
11.77 Liters per minute
Standard Error 3.28
|
13.23 Liters per minute
Standard Error 3.28
|
15.52 Liters per minute
Standard Error 3.29
|
8.72 Liters per minute
Standard Error 3.26
|
16.35 Liters per minute
Standard Error 3.24
|
15.25 Liters per minute
Standard Error 3.26
|
17.38 Liters per minute
Standard Error 3.32
|
SECONDARY outcome
Timeframe: Baseline up to Week 8Population: ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.
Asthma symptoms were recorded in a daily electronic diary (eDiary) by the participants every day in the evening at bedtime and before taking any rescue or study medication and before the assessment of the PEF measurement. Participant's responses to evening assessments indicated no symptoms were considered to be symptom free. For participants, the symptom free days were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of symptom-free days during the 8-Week treatment period minus the Baseline value. Baseline was defined as the last 7 days prior to randomization of the participants.
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 10 mg
n=99 Participants
Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 30 mg
n=99 Participants
Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 100 mg
n=100 Participants
Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 300 mg
n=101 Participants
Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Fluticasone Propionate 100 mcg
n=101 Participants
Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Montelukast 10 mg
n=97 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in the Percentage of Symptom-free Days Averaged Over the 8-Week Treatment Period
|
13.98 Percentage of symptom-free days
Standard Error 2.84
|
15.15 Percentage of symptom-free days
Standard Error 2.84
|
18.54 Percentage of symptom-free days
Standard Error 2.84
|
15.31 Percentage of symptom-free days
Standard Error 2.82
|
14.06 Percentage of symptom-free days
Standard Error 2.81
|
22.18 Percentage of symptom-free days
Standard Error 2.81
|
16.87 Percentage of symptom-free days
Standard Error 2.87
|
SECONDARY outcome
Timeframe: Baseline up to Week 8Population: ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.
Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning upon rising and before taking any rescue or study medication and before the assessment of the PEF measurement. Participant's responses to the morning assessments indicated no symptoms were considered to be symptom free. For participants, the symptom free nights were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of symptom-free nights during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 10 mg
n=99 Participants
Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 30 mg
n=99 Participants
Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 100 mg
n=100 Participants
Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 300 mg
n=101 Participants
Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Fluticasone Propionate 100 mcg
n=100 Participants
Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Montelukast 10 mg
n=97 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in the Percentage of Symptom-free Nights Averaged Over the 8-Week Treatment Period
|
13.99 Percentage of symptom-free nights
Standard Error 2.90
|
14.83 Percentage of symptom-free nights
Standard Error 2.90
|
16.71 Percentage of symptom-free nights
Standard Error 2.90
|
16.12 Percentage of symptom-free nights
Standard Error 2.88
|
12.21 Percentage of symptom-free nights
Standard Error 2.86
|
19.94 Percentage of symptom-free nights
Standard Error 2.88
|
19.39 Percentage of symptom-free nights
Standard Error 2.93
|
SECONDARY outcome
Timeframe: Baseline up to Week 8Population: ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.
The number of inhalations of rescue salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. For participants, the rescue-free days were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of rescue-free days during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 10 mg
n=99 Participants
Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 30 mg
n=99 Participants
Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 100 mg
n=100 Participants
Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 300 mg
n=101 Participants
Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Fluticasone Propionate 100 mcg
n=101 Participants
Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Montelukast 10 mg
n=97 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in the Percentage of Rescue-free Days Averaged Over the 8-Week Treatment Period
|
16.80 Percentage of rescue-free days
Standard Error 3.10
|
22.91 Percentage of rescue-free days
Standard Error 3.1
|
20.91 Percentage of rescue-free days
Standard Error 3.09
|
18.95 Percentage of rescue-free days
Standard Error 3.08
|
18.51 Percentage of rescue-free days
Standard Error 3.06
|
26.39 Percentage of rescue-free days
Standard Error 3.06
|
23.55 Percentage of rescue-free days
Standard Error 3.13
|
SECONDARY outcome
Timeframe: Baseline up to Week 8Population: ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.
The number of inhalations of rescue salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. For participants, the rescue-free nights were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of rescue-free nights during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 10 mg
n=99 Participants
Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 30 mg
n=99 Participants
Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 100 mg
n=100 Participants
Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 300 mg
n=101 Participants
Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Fluticasone Propionate 100 mcg
n=100 Participants
Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Montelukast 10 mg
n=97 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in the Percentage of Rescue-free Nights Averaged Over the 8-Week Treatment Period
|
16.93 Percentage of rescue-free nights
Standard Error 3.04
|
19.28 Percentage of rescue-free nights
Standard Error 3.04
|
17.36 Percentage of rescue-free nights
Standard Error 3.03
|
19.63 Percentage of rescue-free nights
Standard Error 3.02
|
15.71 Percentage of rescue-free nights
Standard Error 3.00
|
24.42 Percentage of rescue-free nights
Standard Error 3.02
|
20.54 Percentage of rescue-free nights
Standard Error 3.07
|
SECONDARY outcome
Timeframe: Baseline up to Week 8Population: ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.
Participants recorded their day-time asthma symptom score in an eDiary each PM at bedtime and before taking any rescue or study medication and before assessing the PEF measurement during the 8-Week treatment period. Day-time asthma symptom scores, as: 0=no asthma symptoms, 1=one episode of short-time asthma symptoms, 2=two or more episodes of short-time asthma symptoms, 3=asthma symptoms occurring during most part of daytime without interference with daily life activities, 4=asthma symptoms occurring during most part of daytime with interference with daily life activities, 5=severe asthma symptoms that disable working or perform normal daily activities. Change from Baseline was calculated as the averaged of day-time asthma symptom score during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 10 mg
n=99 Participants
Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 30 mg
n=99 Participants
Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 100 mg
n=100 Participants
Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 300 mg
n=101 Participants
Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Fluticasone Propionate 100 mcg
n=101 Participants
Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Montelukast 10 mg
n=97 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Day-time Asthma Symptom Score Over the 8-Week Treatment Period
|
-0.34 Day-time symptom scores on a scale
Standard Error 0.06
|
-0.34 Day-time symptom scores on a scale
Standard Error 0.06
|
-0.50 Day-time symptom scores on a scale
Standard Error 0.06
|
-0.36 Day-time symptom scores on a scale
Standard Error 0.06
|
-0.34 Day-time symptom scores on a scale
Standard Error 0.06
|
-0.43 Day-time symptom scores on a scale
Standard Error 0.06
|
-0.41 Day-time symptom scores on a scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Baseline up to Week 8Population: ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.
Participants recorded their night-time asthma symptom score in an eDiary each AM upon rising and before taking any rescue or study medication and before assessing the PEF measurement during the 8-Week treatment period. Night-time asthma symptom scores, as: 0=no asthma symptoms, 1= one awakening or waking early due to asthma symptoms, 2= two or more awakenings due to asthma symptoms (including waking early), 3= asthma symptoms almost prevented the participant from sleeping, 4= severe asthma symptoms completely prevented from sleeping. Change from Baseline was calculated as the averaged of night-time asthma symptom score during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 10 mg
n=99 Participants
Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 30 mg
n=99 Participants
Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 100 mg
n=100 Participants
Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 300 mg
n=101 Participants
Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Fluticasone Propionate 100 mcg
n=100 Participants
Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Montelukast 10 mg
n=97 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Night-time Asthma Symptom Score Over the 8-Week Treatment Period
|
-0.23 Night-time symptom scores on a scale
Standard Error 0.05
|
-0.21 Night-time symptom scores on a scale
Standard Error 0.05
|
-0.33 Night-time symptom scores on a scale
Standard Error 0.05
|
-0.26 Night-time symptom scores on a scale
Standard Error 0.05
|
-0.22 Night-time symptom scores on a scale
Standard Error 0.05
|
-0.29 Night-time symptom scores on a scale
Standard Error 0.05
|
-0.32 Night-time symptom scores on a scale
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Baseline up to WeekPopulation: ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.
The number of inhalations of rescue SABA, salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. Participants who used salbutamol/albuterol inhalation aerosol at day-time were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged number of day-time salbutamol/albuterol inhalation aerosol used during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 10 mg
n=99 Participants
Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 30 mg
n=99 Participants
Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 100 mg
n=100 Participants
Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 300 mg
n=101 Participants
Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Fluticasone Propionate 100 mcg
n=101 Participants
Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Montelukast 10 mg
n=97 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Day-time Rescue Short Acting beta2-agonist (SABA) Usage Over the 8-Week Treatment Period
|
-0.42 Day-time number of inhalations
Standard Error 0.07
|
-0.55 Day-time number of inhalations
Standard Error 0.07
|
-0.68 Day-time number of inhalations
Standard Error 0.07
|
-0.50 Day-time number of inhalations
Standard Error 0.07
|
-0.47 Day-time number of inhalations
Standard Error 0.07
|
-0.67 Day-time number of inhalations
Standard Error 0.07
|
-0.63 Day-time number of inhalations
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline up to Week 8Population: ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.
The numbers of inhalations of rescue SABA, salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. Participants who used salbutamol/albuterol inhalation aerosol at night-time were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged number of night-time salbutamol/albuterol inhalation aerosol used during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 10 mg
n=99 Participants
Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 30 mg
n=99 Participants
Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 100 mg
n=100 Participants
Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 300 mg
n=101 Participants
Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Fluticasone Propionate 100 mcg
n=100 Participants
Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Montelukast 10 mg
n=97 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Night-time Rescue SABA Usage Over the 8-Week Treatment Period
|
-0.30 Night-time number of inhalations
Standard Error 0.07
|
-0.40 Night-time number of inhalations
Standard Error 0.07
|
-0.44 Night-time number of inhalations
Standard Error 0.07
|
-0.42 Night-time number of inhalations
Standard Error 0.07
|
-0.30 Night-time number of inhalations
Standard Error 0.07
|
-0.47 Night-time number of inhalations
Standard Error 0.07
|
-0.46 Night-time number of inhalations
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Upto 8 WeeksPopulation: ITT Population. Only those participants with analyzable data at the indicated time point were assessed.
The participants who met any of the following withdrawal criteria were considered to be withdrawn due to lack of efficacy: 1) Clinic FEV1 below stability limit calculated at Visit 3. 2) More than three days between two consecutive visits, PEF has fallen below stability limit calculated at Visit 3. 3) Use of 12 or more inhalations of SABA per day for more than two days between consecutive visits. 4) Asthma exacerbation defined as worsening requiring any treatment other than study medication or rescue medication. This included requiring the use of systemic or inhaled corticosteroids and /or emergency room visit or hospitalization for the treatment of asthma. The stability limit was calculated as best pre-salbutamol/albuterol FEV1 at Visit 3 x 80 percent (%).
Outcome measures
| Measure |
Placebo
n=100 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 10 mg
n=99 Participants
Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 30 mg
n=100 Participants
Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 100 mg
n=100 Participants
Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 300 mg
n=101 Participants
Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Fluticasone Propionate 100 mcg
n=103 Participants
Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Montelukast 10 mg
n=97 Participants
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period
|
11 Participants
|
11 Participants
|
9 Participants
|
11 Participants
|
13 Participants
|
8 Participants
|
7 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
GSK2190915 10mg
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
GSK2190915 30mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
GSK2190915 100mg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
GSK2190915 300mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Fluticasone Propionate 100 mcg
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Montelukast 10mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=100 participants at risk
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 10mg
n=99 participants at risk
Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 30mg
n=100 participants at risk
Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 100mg
n=100 participants at risk
Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 300mg
n=101 participants at risk
Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Fluticasone Propionate 100 mcg
n=103 participants at risk
Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Montelukast 10mg
n=97 participants at risk
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
|
|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/100 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
0.00%
0/99 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
0.00%
0/100 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
0.00%
0/100 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
0.00%
0/101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
0.97%
1/103 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
0.00%
0/97 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/100 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
1.0%
1/99 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
0.00%
0/100 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
0.00%
0/100 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
0.00%
0/101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
0.00%
0/103 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
0.00%
0/97 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/100 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
0.00%
0/99 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
0.00%
0/100 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
1.0%
1/100 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
0.00%
0/101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
0.00%
0/103 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
0.00%
0/97 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
Other adverse events
| Measure |
Placebo
n=100 participants at risk
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 10mg
n=99 participants at risk
Participants received one tablet of 10 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 30mg
n=100 participants at risk
Participants received one tablet of 30 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 100mg
n=100 participants at risk
Participants received one tablet of 100 mg GSK2190915 orally QD and one tablet of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
GSK2190915 300mg
n=101 participants at risk
Participants received one tablet of 100 mg GSK2190915 and one tablet of 200 mg GSK 2190915 orally QD plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo BID via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Fluticasone Propionate 100 mcg
n=103 participants at risk
Participants received one dose of FP 100 mcg BID via DPI plus two tablets of placebo in morning and another dose of FP 100 mcg via DPI plus one capsule of montelukast matching placebo orally QD in evening for the 8-Weeks.
|
Montelukast 10mg
n=97 participants at risk
Participants received two tablets of placebo orally plus one dose of FP matching placebo BID via DPI in morning and another dose of FP matching placebo via DPI plus one capsule of montelukast 10 mg orally QD in evening for the 8-Weeks.
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
3.0%
3/100 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
7.1%
7/99 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
2.0%
2/100 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
4.0%
4/100 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
4.0%
4/101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
8.7%
9/103 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
9.3%
9/97 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
5/100 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
6.1%
6/99 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
3.0%
3/100 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
2.0%
2/100 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
5.0%
5/101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
4.9%
5/103 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
5.2%
5/97 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
|
Infections and infestations
Pharyngitis
|
2.0%
2/100 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
0.00%
0/99 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
1.0%
1/100 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
3.0%
3/100 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
0.00%
0/101 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
0.00%
0/103 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
1.0%
1/97 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of administration of the study drug until the follow-up contact (up to Week 9).
SAEs and non-serious AEs were reported for members of the ITT population.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER