Asthma
Conditions
Keywords
Efficacy, Asthma, Safety, Fluticasone Propionate, FLAP, Beta-agonists, GSK2190915, Montelukast, Placebo, FLAIR
Brief summary
To evaluate the efficacy, dose response and safety of four doses of GSK2190915 in tablet form (10mg, 30mg, 100mg and 300mg) administered once daily, over 8 weeks compared with placebo in adolescent and adult subjects (12 years of age and older) with persistent asthma. These data will form the basis for the selection of the optimal daily dose of GSK2190915 to be carried forward in Phase III asthma studies. The study also includes Fluticasone Propionate Inhalation Powder (100 mcg, twice daily) and Montelukast (10mg, once daily) to allow for an exploratory analysis of the efficacy of GSK2190915 versus a low dose inhaled corticosteroid and a leukotriene receptor antagonist.
Interventions
DRUGFluticasone Propionate 100mcg via ACCUHALER/DISKUS
Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS
DRUGGSK2190915 100mg
GSK2190915 100mg (1 x 100mg) once daily in the morning
DRUGGSK2190915 10mg
GSK2190915 10mg (1 x 10mg) once daily in the morning
DRUGGSK2190915 300mg
GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning
DRUGGSK2190915 30mg
GSK2190915 30mg (1 x 30mg) once daily in the morning
DRUGMontelukast 10mg
Montelukast 10mg (1 x 10mg capsule) once daily in the evening
DRUGPlacebo GSK2190915 one tablet
Placebo tablet, one tablet once daily in the morning
DRUGPlacebo montelukast
Placebo capsule once daily in the evening
DRUGPlacebo fluticasone propionate via ACCUHALER/DISKUS
Inhaled placebo twice daily via ACCUHALER/DISKUS
DRUGPlacebo GSK2190915 two tablets
Placebo tablet, two tablets once daily in the morning
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type of Subject: Outpatient * Age: ≥12 years of age * Gender: Eligible Female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control) * Asthma Diagnosis: As defined by NIH * Severity of Disease: FEV1 50-85% predicted AND in current and former smokers a post salbutamol/albuterol ratio \>0.70 * Reversibility: ≥12% and ≥200mL in FEV1 within 30 ±15 minutes following salbutamol/albuterol * Current anti-asthma therapy: Using short-acting beta-agonist (SABA) for ≥3 months * Tobacco use: Non-smoker /former smoker with ≤10 pack years or current smoker with ≤10 pack years * QTC: QTc(F)\<450msec or QTc(F)\<480 for subjects with Bundle Branch Block * Liver function: Normal liver function * Informed Consent
Exclusion criteria
* History of Life-threatening asthma: Within previous 5 years * Asthma Exacerbation: Requiring OCS within 3 months or hospitalisation within 6 months * Respiratory Infection: Not resolved within the 4 weeks before V1 AND led to a change in asthma management OR treatment with antibiotics OR is expected to affect the subject's asthma status or ability to participate * Corticosteroid Use: ICS used within 6 weeks or OCS/depot corticosteroids within 12 weeks * OATP1B1 substrates: OATP1B1 substrates (e.g. statins, rifampicin, bromosulphophthalein, benzylpenicillin, methotrexate) within 4 weeks * Immunosuppressive medications: Either using or required during the study * Liver disease: Current or chronic history * Concurrent disease/abnormalities: Clinically significant uncontrolled disease * Investigational medications: Participation in a study or used investigational drug within 30 days * Drug allergy: β-agonists, corticosteroids, constituents of inhalers * Milk Protein Allergy: History of severe milk protein allergy * Compliance: Factors likely to impair compliance either with regards to study medication, procedures or attendance * Unable or unwilling to follow instructions: Procedures, dosing directions, e-diaries or pMDIs * History of alcohol or drug abuse: Likely to interfere with the study * Affiliation with Investigator's Site: Relative or employee
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1) | Baseline and Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | 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) |
| Mean Change From Baseline in Daily Trough AM PEF Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | 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). |
| Mean Change From Baseline in the Percentage of Symptom-free Days Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | 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. |
| Mean Change From Baseline in the Percentage of Symptom-free Nights Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | 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). |
| Mean Change From Baseline in the Percentage of Rescue-free Days Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | 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). |
| Mean Change From Baseline in the Percentage of Rescue-free Nights Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | 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). |
| Mean Change From Baseline in Day-time Asthma Symptom Score Over the 8-Week Treatment Period | Baseline up to Week 8 | 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). |
| Mean Change From Baseline in Night-time Asthma Symptom Score Over the 8-Week Treatment Period | Baseline up to Week 8 | 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). |
| Mean Change From Baseline in Day-time Rescue Short Acting beta2-agonist (SABA) Usage Over the 8-Week Treatment Period | Baseline up to Week | 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). |
| Mean Change From Baseline in Night-time Rescue SABA Usage Over the 8-Week Treatment Period | Baseline up to Week 8 | 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). |
| Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period | Upto 8 Weeks | 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 (%). |
Countries
Bulgaria, Japan, Poland, Romania, Ukraine, United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo 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. | 100 |
| GSK2190915 10 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. | 99 |
| GSK2190915 30 mg 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. | 100 |
| GSK2190915 100 mg 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. | 100 |
| GSK2190915 300 mg 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. | 101 |
| Fluticasone Propionate 100 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. | 103 |
| Montelukast 10 mg 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. | 97 |
| Total | 700 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 | 3 | 0 | 2 | 1 | 2 |
| Overall Study | Lack of Efficacy | 11 | 11 | 9 | 11 | 13 | 8 | 7 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Met Protocol-defined Stopping Criteria | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 1 | 1 | 0 | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 1 | 0 | 1 | 3 | 1 |
| Overall Study | Sponsor decision to amend protocol | 7 | 4 | 2 | 5 | 7 | 2 | 6 |
| Overall Study | Withdrawal by Subject | 8 | 4 | 2 | 2 | 2 | 5 | 2 |
Baseline characteristics
| Characteristic | Placebo | Total | Montelukast 10 mg | Fluticasone Propionate 100 mcg | GSK2190915 300 mg | GSK2190915 100 mg | GSK2190915 30 mg | GSK2190915 10 mg |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 42.3 Years STANDARD_DEVIATION 16.13 | 42.2 Years STANDARD_DEVIATION 15.25 | 44.3 Years STANDARD_DEVIATION 14.97 | 41.5 Years STANDARD_DEVIATION 15.16 | 42.2 Years STANDARD_DEVIATION 14.15 | 42.2 Years STANDARD_DEVIATION 14.63 | 43.1 Years STANDARD_DEVIATION 16.17 | 40 Years STANDARD_DEVIATION 15.56 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 4 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 85 Participants | 12 Participants | 12 Participants | 13 Participants | 11 Participants | 12 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 62 Participants | 9 Participants | 7 Participants | 9 Participants | 9 Participants | 10 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 82 Participants | 549 Participants | 76 Participants | 83 Participants | 78 Participants | 78 Participants | 78 Participants | 74 Participants |
| Sex: Female, Male Female | 88 Participants | 644 Participants | 89 Participants | 97 Participants | 93 Participants | 92 Participants | 94 Participants | 91 Participants |
| Sex: Female, Male Male | 12 Participants | 56 Participants | 8 Participants | 6 Participants | 8 Participants | 8 Participants | 6 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 99 | 0 / 100 | 0 / 100 | 0 / 101 | 0 / 103 | 0 / 97 |
| other Total, other adverse events | 10 / 100 | 13 / 99 | 6 / 100 | 9 / 100 | 9 / 101 | 14 / 103 | 15 / 97 |
| serious Total, serious adverse events | 0 / 100 | 1 / 99 | 0 / 100 | 1 / 100 | 0 / 101 | 1 / 103 | 0 / 97 |
Outcome results
Primary
Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1)
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.
Time frame: Baseline and Week 8
Population: 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 \[LOCF\]).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| GSK2190915 10 mg | Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1) | 0.18 Liters | Standard Error 0.04 |
| GSK2190915 30 mg | Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1) | 0.23 Liters | Standard Error 0.04 |
| GSK2190915 100 mg | Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1) | 0.19 Liters | Standard Error 0.04 |
| GSK2190915 300 mg | Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1) | 0.19 Liters | Standard Error 0.04 |
| Fluticasone Propionate 100 mcg | Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1) | 0.31 Liters | Standard Error 0.04 |
| Montelukast 10 mg | Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1) | 0.19 Liters | Standard Error 0.04 |
p-value: 0.32695% CI: [-0.06, 0.17]ANCOVA
p-value: 0.06695% CI: [-0.01, 0.22]ANCOVA
p-value: 0.22495% CI: [-0.04, 0.18]ANCOVA
p-value: 0.27195% CI: [-0.05, 0.17]ANCOVA
p-value: <0.00195% CI: [0.08, 0.3]ANCOVA
p-value: 0.2295% CI: [-0.04, 0.18]ANCOVA
Secondary
Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period
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)
Time frame: Baseline up to Week 8
Population: ITT Population. Only those participants with analyzable data at the indicated time point were assessed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| GSK2190915 10 mg | Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period | 7.62 Liters per minute | Standard Error 3.19 |
| GSK2190915 30 mg | Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period | 9.37 Liters per minute | Standard Error 3.2 |
| GSK2190915 100 mg | Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period | 6.21 Liters per minute | Standard Error 3.17 |
| GSK2190915 300 mg | Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period | 10.33 Liters per minute | Standard Error 3.15 |
| Fluticasone Propionate 100 mcg | Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period | 10.46 Liters per minute | Standard Error 3.16 |
| Montelukast 10 mg | Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period | 8.53 Liters per minute | Standard Error 3.24 |
p-value: 0.93295% CI: [-9.25, 8.48]ANCOVA
p-value: 0.76295% CI: [-7.5, 10.23]ANCOVA
p-value: 0.68995% CI: [-10.62, 7.03]ANCOVA
p-value: 0.60595% CI: [-6.49, 11.13]ANCOVA
p-value: 0.58495% CI: [-6.36, 11.28]ANCOVA
p-value: 0.90795% CI: [-8.4, 9.45]ANCOVA
Secondary
Mean Change From Baseline in Daily Trough AM PEF Averaged Over the 8-Week Treatment Period
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).
Time frame: Baseline up to Week 8
Population: ITT Population. Only those participants with analyzable data at the indicated time point were assessed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| GSK2190915 10 mg | Mean Change From Baseline in Daily Trough AM PEF Averaged Over the 8-Week Treatment Period | 13.23 Liters per minute | Standard Error 3.28 |
| GSK2190915 30 mg | Mean Change From Baseline in Daily Trough AM PEF Averaged Over the 8-Week Treatment Period | 15.52 Liters per minute | Standard Error 3.29 |
| GSK2190915 100 mg | Mean Change From Baseline in Daily Trough AM PEF Averaged Over the 8-Week Treatment Period | 8.72 Liters per minute | Standard Error 3.26 |
| GSK2190915 300 mg | Mean Change From Baseline in Daily Trough AM PEF Averaged Over the 8-Week Treatment Period | 16.35 Liters per minute | Standard Error 3.24 |
| Fluticasone Propionate 100 mcg | Mean Change From Baseline in Daily Trough AM PEF Averaged Over the 8-Week Treatment Period | 15.25 Liters per minute | Standard Error 3.26 |
| Montelukast 10 mg | Mean Change From Baseline in Daily Trough AM PEF Averaged Over the 8-Week Treatment Period | 17.38 Liters per minute | Standard Error 3.32 |
p-value: 0.75395% CI: [-7.65, 10.58]ANCOVA
p-value: 0.41995% CI: [-5.36, 12.87]ANCOVA
p-value: 0.5195% CI: [-12.12, 6.03]ANCOVA
p-value: 0.3295% CI: [-4.47, 13.64]ANCOVA
p-value: 0.45295% CI: [-5.61, 12.58]ANCOVA
p-value: 0.22995% CI: [-3.55, 14.78]ANCOVA
Secondary
Mean Change From Baseline in Day-time Asthma Symptom Score Over the 8-Week Treatment Period
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).
Time frame: Baseline up to Week 8
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| GSK2190915 10 mg | 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 |
| GSK2190915 30 mg | Mean Change From Baseline in Day-time Asthma Symptom Score Over the 8-Week Treatment Period | -0.50 Day-time symptom scores on a scale | Standard Error 0.06 |
| GSK2190915 100 mg | Mean Change From Baseline in Day-time Asthma Symptom Score Over the 8-Week Treatment Period | -0.36 Day-time symptom scores on a scale | Standard Error 0.06 |
| GSK2190915 300 mg | 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 |
| Fluticasone Propionate 100 mcg | Mean Change From Baseline in Day-time Asthma Symptom Score Over the 8-Week Treatment Period | -0.43 Day-time symptom scores on a scale | Standard Error 0.06 |
| Montelukast 10 mg | Mean Change From Baseline in Day-time Asthma Symptom Score Over the 8-Week Treatment Period | -0.41 Day-time symptom scores on a scale | Standard Error 0.06 |
p-value: 0.95195% CI: [-0.17, 0.16]ANCOVA
p-value: 0.04395% CI: [-0.33, -0.01]ANCOVA
p-value: 0.73495% CI: [-0.19, 0.13]ANCOVA
p-value: 0.97295% CI: [-0.16, 0.16]ANCOVA
p-value: 0.23895% CI: [-0.26, 0.06]ANCOVA
p-value: 0.3695% CI: [-0.24, 0.09]ANCOVA
Secondary
Mean Change From Baseline in Day-time Rescue Short Acting beta2-agonist (SABA) Usage Over the 8-Week Treatment Period
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).
Time frame: Baseline up to Week
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| GSK2190915 10 mg | Mean Change From Baseline in Day-time Rescue Short Acting beta2-agonist (SABA) Usage Over the 8-Week Treatment Period | -0.55 Day-time number of inhalations | Standard Error 0.07 |
| GSK2190915 30 mg | Mean Change From Baseline in Day-time Rescue Short Acting beta2-agonist (SABA) Usage Over the 8-Week Treatment Period | -0.68 Day-time number of inhalations | Standard Error 0.07 |
| GSK2190915 100 mg | Mean Change From Baseline in Day-time Rescue Short Acting beta2-agonist (SABA) Usage Over the 8-Week Treatment Period | -0.50 Day-time number of inhalations | Standard Error 0.07 |
| GSK2190915 300 mg | Mean Change From Baseline in Day-time Rescue Short Acting beta2-agonist (SABA) Usage Over the 8-Week Treatment Period | -0.47 Day-time number of inhalations | Standard Error 0.07 |
| Fluticasone Propionate 100 mcg | Mean Change From Baseline in Day-time Rescue Short Acting beta2-agonist (SABA) Usage Over the 8-Week Treatment Period | -0.67 Day-time number of inhalations | Standard Error 0.07 |
| Montelukast 10 mg | Mean Change From Baseline in Day-time Rescue Short Acting beta2-agonist (SABA) Usage Over the 8-Week Treatment Period | -0.63 Day-time number of inhalations | Standard Error 0.07 |
p-value: 0.20995% CI: [-0.33, 0.07]ANCOVA
p-value: 0.01195% CI: [-0.47, -0.06]ANCOVA
p-value: 0.46495% CI: [-0.28, 0.13]ANCOVA
p-value: 0.66295% CI: [-0.25, 0.16]ANCOVA
p-value: 0.01895% CI: [-0.45, -0.04]ANCOVA
p-value: 0.04795% CI: [-0.41, 0]ANCOVA
Secondary
Mean Change From Baseline in Night-time Asthma Symptom Score Over the 8-Week Treatment Period
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).
Time frame: Baseline up to Week 8
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| GSK2190915 10 mg | Mean Change From Baseline in Night-time Asthma Symptom Score Over the 8-Week Treatment Period | -0.21 Night-time symptom scores on a scale | Standard Error 0.05 |
| GSK2190915 30 mg | Mean Change From Baseline in Night-time Asthma Symptom Score Over the 8-Week Treatment Period | -0.33 Night-time symptom scores on a scale | Standard Error 0.05 |
| GSK2190915 100 mg | Mean Change From Baseline in Night-time Asthma Symptom Score Over the 8-Week Treatment Period | -0.26 Night-time symptom scores on a scale | Standard Error 0.05 |
| GSK2190915 300 mg | Mean Change From Baseline in Night-time Asthma Symptom Score Over the 8-Week Treatment Period | -0.22 Night-time symptom scores on a scale | Standard Error 0.05 |
| Fluticasone Propionate 100 mcg | Mean Change From Baseline in Night-time Asthma Symptom Score Over the 8-Week Treatment Period | -0.29 Night-time symptom scores on a scale | Standard Error 0.05 |
| Montelukast 10 mg | Mean Change From Baseline in Night-time Asthma Symptom Score Over the 8-Week Treatment Period | -0.32 Night-time symptom scores on a scale | Standard Error 0.05 |
p-value: 0.69295% CI: [-0.11, 0.17]ANCOVA
p-value: 0.17695% CI: [-0.24, 0.04]ANCOVA
p-value: 0.76895% CI: [-0.16, 0.12]ANCOVA
p-value: 0.88795% CI: [-0.13, 0.15]ANCOVA
p-value: 0.47195% CI: [-0.19, 0.09]ANCOVA
p-value: 0.24895% CI: [-0.22, 0.06]ANCOVA
Secondary
Mean Change From Baseline in Night-time Rescue SABA Usage Over the 8-Week Treatment Period
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).
Time frame: Baseline up to Week 8
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| GSK2190915 10 mg | Mean Change From Baseline in Night-time Rescue SABA Usage Over the 8-Week Treatment Period | -0.40 Night-time number of inhalations | Standard Error 0.07 |
| GSK2190915 30 mg | Mean Change From Baseline in Night-time Rescue SABA Usage Over the 8-Week Treatment Period | -0.44 Night-time number of inhalations | Standard Error 0.07 |
| GSK2190915 100 mg | Mean Change From Baseline in Night-time Rescue SABA Usage Over the 8-Week Treatment Period | -0.42 Night-time number of inhalations | Standard Error 0.07 |
| GSK2190915 300 mg | 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 |
| Fluticasone Propionate 100 mcg | Mean Change From Baseline in Night-time Rescue SABA Usage Over the 8-Week Treatment Period | -0.47 Night-time number of inhalations | Standard Error 0.07 |
| Montelukast 10 mg | Mean Change From Baseline in Night-time Rescue SABA Usage Over the 8-Week Treatment Period | -0.46 Night-time number of inhalations | Standard Error 0.07 |
p-value: 0.395% CI: [-0.28, 0.09]ANCOVA
p-value: 0.14595% CI: [-0.32, 0.05]ANCOVA
p-value: 0.1995% CI: [-0.31, 0.06]ANCOVA
p-value: 0.9895% CI: [-0.19, 0.18]ANCOVA
p-value: 0.0795% CI: [-0.36, 0.01]ANCOVA
p-value: 0.09595% CI: [-0.34, 0.03]ANCOVA
Secondary
Mean Change From Baseline in the Percentage of Rescue-free Days Averaged Over the 8-Week Treatment Period
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).
Time frame: Baseline up to Week 8
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 3.1 |
| GSK2190915 10 mg | Mean Change From Baseline in the Percentage of Rescue-free Days Averaged Over the 8-Week Treatment Period | 22.91 Percentage of rescue-free days | Standard Error 3.1 |
| GSK2190915 30 mg | Mean Change From Baseline in the Percentage of Rescue-free Days Averaged Over the 8-Week Treatment Period | 20.91 Percentage of rescue-free days | Standard Error 3.09 |
| GSK2190915 100 mg | Mean Change From Baseline in the Percentage of Rescue-free Days Averaged Over the 8-Week Treatment Period | 18.95 Percentage of rescue-free days | Standard Error 3.08 |
| GSK2190915 300 mg | Mean Change From Baseline in the Percentage of Rescue-free Days Averaged Over the 8-Week Treatment Period | 18.51 Percentage of rescue-free days | Standard Error 3.06 |
| Fluticasone Propionate 100 mcg | Mean Change From Baseline in the Percentage of Rescue-free Days Averaged Over the 8-Week Treatment Period | 26.39 Percentage of rescue-free days | Standard Error 3.06 |
| Montelukast 10 mg | Mean Change From Baseline in the Percentage of Rescue-free Days Averaged Over the 8-Week Treatment Period | 23.55 Percentage of rescue-free days | Standard Error 3.13 |
p-value: 0.16495% CI: [-2.5, 14.71]ANCOVA
p-value: 0.34995% CI: [-4.49, 12.7]ANCOVA
p-value: 0.62395% CI: [-6.42, 10.72]ANCOVA
p-value: 0.69495% CI: [-6.84, 10.26]ANCOVA
p-value: 0.02895% CI: [1.03, 18.15]ANCOVA
p-value: 0.12595% CI: [-1.89, 15.38]ANCOVA
Secondary
Mean Change From Baseline in the Percentage of Rescue-free Nights Averaged Over the 8-Week Treatment Period
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).
Time frame: Baseline up to Week 8
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| GSK2190915 10 mg | Mean Change From Baseline in the Percentage of Rescue-free Nights Averaged Over the 8-Week Treatment Period | 19.28 Percentage of rescue-free nights | Standard Error 3.04 |
| GSK2190915 30 mg | Mean Change From Baseline in the Percentage of Rescue-free Nights Averaged Over the 8-Week Treatment Period | 17.36 Percentage of rescue-free nights | Standard Error 3.03 |
| GSK2190915 100 mg | Mean Change From Baseline in the Percentage of Rescue-free Nights Averaged Over the 8-Week Treatment Period | 19.63 Percentage of rescue-free nights | Standard Error 3.02 |
| GSK2190915 300 mg | Mean Change From Baseline in the Percentage of Rescue-free Nights Averaged Over the 8-Week Treatment Period | 15.71 Percentage of rescue-free nights | Standard Error 3 |
| Fluticasone Propionate 100 mcg | Mean Change From Baseline in the Percentage of Rescue-free Nights Averaged Over the 8-Week Treatment Period | 24.42 Percentage of rescue-free nights | Standard Error 3.02 |
| Montelukast 10 mg | Mean Change From Baseline in the Percentage of Rescue-free Nights Averaged Over the 8-Week Treatment Period | 20.54 Percentage of rescue-free nights | Standard Error 3.07 |
p-value: 0.58595% CI: [-6.09, 10.78]ANCOVA
p-value: 0.9295% CI: [-8, 8.86]ANCOVA
p-value: 0.52895% CI: [-5.7, 11.11]ANCOVA
p-value: 0.77695% CI: [-9.6, 7.17]ANCOVA
p-value: 0.08195% CI: [-0.92, 15.9]ANCOVA
p-value: 0.40395% CI: [-4.87, 12.09]ANCOVA
Secondary
Mean Change From Baseline in the Percentage of Symptom-free Days Averaged Over the 8-Week Treatment Period
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.
Time frame: Baseline up to Week 8
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| GSK2190915 10 mg | Mean Change From Baseline in the Percentage of Symptom-free Days Averaged Over the 8-Week Treatment Period | 15.15 Percentage of symptom-free days | Standard Error 2.84 |
| GSK2190915 30 mg | Mean Change From Baseline in the Percentage of Symptom-free Days Averaged Over the 8-Week Treatment Period | 18.54 Percentage of symptom-free days | Standard Error 2.84 |
| GSK2190915 100 mg | Mean Change From Baseline in the Percentage of Symptom-free Days Averaged Over the 8-Week Treatment Period | 15.31 Percentage of symptom-free days | Standard Error 2.82 |
| GSK2190915 300 mg | Mean Change From Baseline in the Percentage of Symptom-free Days Averaged Over the 8-Week Treatment Period | 14.06 Percentage of symptom-free days | Standard Error 2.81 |
| Fluticasone Propionate 100 mcg | Mean Change From Baseline in the Percentage of Symptom-free Days Averaged Over the 8-Week Treatment Period | 22.18 Percentage of symptom-free days | Standard Error 2.81 |
| Montelukast 10 mg | Mean Change From Baseline in the Percentage of Symptom-free Days Averaged Over the 8-Week Treatment Period | 16.87 Percentage of symptom-free days | Standard Error 2.87 |
p-value: 0.77195% CI: [-6.73, 9.07]ANCOVA
p-value: 0.25795% CI: [-3.33, 12.45]ANCOVA
p-value: 0.74195% CI: [-6.54, 9.19]ANCOVA
p-value: 0.98395% CI: [-7.76, 7.93]ANCOVA
p-value: 0.04195% CI: [0.34, 16.07]ANCOVA
p-value: 0.47595% CI: [-5.05, 10.83]ANCOVA
Secondary
Mean Change From Baseline in the Percentage of Symptom-free Nights Averaged Over the 8-Week Treatment Period
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).
Time frame: Baseline up to Week 8
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 2.9 |
| GSK2190915 10 mg | Mean Change From Baseline in the Percentage of Symptom-free Nights Averaged Over the 8-Week Treatment Period | 14.83 Percentage of symptom-free nights | Standard Error 2.9 |
| GSK2190915 30 mg | Mean Change From Baseline in the Percentage of Symptom-free Nights Averaged Over the 8-Week Treatment Period | 16.71 Percentage of symptom-free nights | Standard Error 2.9 |
| GSK2190915 100 mg | Mean Change From Baseline in the Percentage of Symptom-free Nights Averaged Over the 8-Week Treatment Period | 16.12 Percentage of symptom-free nights | Standard Error 2.88 |
| GSK2190915 300 mg | Mean Change From Baseline in the Percentage of Symptom-free Nights Averaged Over the 8-Week Treatment Period | 12.21 Percentage of symptom-free nights | Standard Error 2.86 |
| Fluticasone Propionate 100 mcg | Mean Change From Baseline in the Percentage of Symptom-free Nights Averaged Over the 8-Week Treatment Period | 19.94 Percentage of symptom-free nights | Standard Error 2.88 |
| Montelukast 10 mg | Mean Change From Baseline in the Percentage of Symptom-free Nights Averaged Over the 8-Week Treatment Period | 19.39 Percentage of symptom-free nights | Standard Error 2.93 |
p-value: 0.83895% CI: [-7.22, 8.89]ANCOVA
p-value: 0.50895% CI: [-5.33, 10.76]ANCOVA
p-value: 0.60395% CI: [-5.9, 10.14]ANCOVA
p-value: 0.66295% CI: [-9.78, 6.22]ANCOVA
p-value: 0.14695% CI: [-2.08, 13.98]ANCOVA
p-value: 0.19195% CI: [-2.69, 13.48]ANCOVA
Secondary
Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period
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 (%).
Time frame: Upto 8 Weeks
Population: ITT Population. Only those participants with analyzable data at the indicated time point were assessed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period | 11 Participants |
| GSK2190915 10 mg | Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period | 11 Participants |
| GSK2190915 30 mg | Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period | 9 Participants |
| GSK2190915 100 mg | Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period | 11 Participants |
| GSK2190915 300 mg | Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period | 13 Participants |
| Fluticasone Propionate 100 mcg | Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period | 8 Participants |
| Montelukast 10 mg | Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period | 7 Participants |
p-value: 1Fisher Exact
p-value: 0.814Fisher Exact
p-value: 1Fisher Exact
p-value: 0.828Fisher Exact
p-value: 0.477Fisher Exact
p-value: 0.46Fisher Exact