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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2190915 10mg and placebo | Experimental | GSK2190915 10mg (1 x 10mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS |
|
| GSK2190915 30mg and placebo | Experimental | GSK2190915 30mg (1 x 30mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS |
|
| GSK2190915 100mg QD and placebo | Experimental | GSK2190915 100mg (1 x 100mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS |
|
| GSK2190915 300mg QD and placebo | Experimental | GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone Propionate 100mcg via ACCUHALER/DISKUS | Drug | Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35209 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23682661 | Derived | Follows RM, Snowise NG, Ho SY, Ambery CL, Smart K, McQuade BA. Efficacy, safety and tolerability of GSK2190915, a 5-lipoxygenase activating protein inhibitor, in adults and adolescents with persistent asthma: a randomised dose-ranging study. Respir Res. 2013 May 17;14(1):54. doi: 10.1186/1465-9921-14-54. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 112186 | Annotated Case Report Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Fluticasone propionate 100mcg and placebo | Active Comparator | Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS and two placebo tablets in the morning and one placebo capsule in the evening |
|
| Montelukast 10mg and placebo | Active Comparator | Montelukast 10mg (1 x 10mg capsule) once daily in the evening and two placebo tablets in the morning and inhaled placebo twice daily via ACCUHALER/DISKUS |
|
| Placebo Comparator | Placebo Comparator | Two GSK2190915 placebo tablets once daily in the morning, montelukast placebo capsule once daily in the evening and fluticasone propionate placebo twice daily via ACCUHALER/DISKUS |
|
| GSK2190915 100mg | Drug | GSK2190915 100mg (1 x 100mg) once daily in the morning |
|
| GSK2190915 10mg | Drug | GSK2190915 10mg (1 x 10mg) once daily in the morning |
|
| GSK2190915 300mg | Drug | GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning |
|
| GSK2190915 30mg | Drug | GSK2190915 30mg (1 x 30mg) once daily in the morning |
|
| Montelukast 10mg | Drug | Montelukast 10mg (1 x 10mg capsule) once daily in the evening |
|
| Placebo GSK2190915 one tablet | Drug | Placebo tablet, one tablet once daily in the morning |
|
| Placebo montelukast | Drug | Placebo capsule once daily in the evening |
|
| Placebo fluticasone propionate via ACCUHALER/DISKUS | Drug | Inhaled placebo twice daily via ACCUHALER/DISKUS |
|
| Placebo GSK2190915 two tablets | Drug | Placebo tablet, two tablets once daily in the morning |
|
| Baseline up to Week 8 |
| 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). | Baseline up to Week 8 |
| 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. | Baseline up to Week 8 |
| 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). | Baseline up to Week 8 |
| 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). | Baseline up to Week 8 |
| 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). | Baseline up to Week 8 |
| 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). | Baseline up to Week 8 |
| 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). | Baseline up to Week 8 |
| 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). | Baseline up to Week |
| 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). | Baseline up to Week 8 |
| 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 (%). | Upto 8 Weeks |
| Huntington Beach |
| California |
| 92647 |
| United States |
| GSK Investigational Site | Newport Beach | California | 92663 | United States |
| GSK Investigational Site | San Diego | California | 92123 | United States |
| GSK Investigational Site | Tallahassee | Florida | 32308 | United States |
| GSK Investigational Site | Owensboro | Kentucky | 42301 | United States |
| GSK Investigational Site | Metairie | Louisiana | 70006 | United States |
| GSK Investigational Site | Bangor | Maine | 04401 | United States |
| GSK Investigational Site | Ypsilanti | Michigan | 48197 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55402 | United States |
| GSK Investigational Site | Columbia | Missouri | 65203 | United States |
| GSK Investigational Site | Rolla | Missouri | 65401 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Ocean City | New Jersey | 07712 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27607 | United States |
| GSK Investigational Site | Canton | Ohio | 44718 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73103 | United States |
| GSK Investigational Site | Medford | Oregon | 97504 | United States |
| GSK Investigational Site | Orangeburg | South Carolina | 29118 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Waco | Texas | 76712 | United States |
| GSK Investigational Site | Bellingham | Washington | 98225 | United States |
| GSK Investigational Site | Pleven | 5800 | Bulgaria |
| GSK Investigational Site | Plovdiv | 4003 | Bulgaria |
| GSK Investigational Site | Rousse | 7000 | Bulgaria |
| GSK Investigational Site | Sofia | 1000 | Bulgaria |
| GSK Investigational Site | Sofia | 1202 | Bulgaria |
| GSK Investigational Site | Sofia | 1407 | Bulgaria |
| GSK Investigational Site | Sofia | 1431 | Bulgaria |
| GSK Investigational Site | Stara Zagora | 6000 | Bulgaria |
| GSK Investigational Site | Varna | 9010 | Bulgaria |
| GSK Investigational Site | Chiba | 292-0805 | Japan |
| GSK Investigational Site | Fukuoka | 819-0006 | Japan |
| GSK Investigational Site | Fukuoka | 819-1102 | Japan |
| GSK Investigational Site | Hokkaido | 062-0034 | Japan |
| GSK Investigational Site | Hokkaido | 064-0801 | Japan |
| GSK Investigational Site | Ibaraki | 319-1113 | Japan |
| GSK Investigational Site | Kanagawa | 210-0852 | Japan |
| GSK Investigational Site | Osaka | 530-0001 | Japan |
| GSK Investigational Site | Osaka | 565-0853 | Japan |
| GSK Investigational Site | Saitama | 343-0851 | Japan |
| GSK Investigational Site | Tokyo | 102-0083 | Japan |
| GSK Investigational Site | Tokyo | 103-0027 | Japan |
| GSK Investigational Site | Tokyo | 103-0028 | Japan |
| GSK Investigational Site | Tokyo | 130-8587 | Japan |
| GSK Investigational Site | Tokyo | 153-0051 | Japan |
| GSK Investigational Site | Tokyo | 154-0024 | Japan |
| GSK Investigational Site | Tokyo | 158-0097 | Japan |
| GSK Investigational Site | Tokyo | 171-0014 | Japan |
| GSK Investigational Site | Tokyo | 190-0013 | Japan |
| GSK Investigational Site | Bialystok | 15-084 | Poland |
| GSK Investigational Site | Katowice | 40-018 | Poland |
| GSK Investigational Site | Krakow | 31-024 | Poland |
| GSK Investigational Site | Libiąż | 32-590 | Poland |
| GSK Investigational Site | Lodz | 93-329 | Poland |
| GSK Investigational Site | Poznan | 60-693 | Poland |
| GSK Investigational Site | Tarnów | 33-100 | Poland |
| GSK Investigational Site | Brasov | 500112 | Romania |
| GSK Investigational Site | Bucharest | 020125 | Romania |
| GSK Investigational Site | Bucharest | 022102 | Romania |
| GSK Investigational Site | Bucharest | 050159 | Romania |
| GSK Investigational Site | Cluj-Napoca | 400217 | Romania |
| GSK Investigational Site | Cluj-Napoca | 400371 | Romania |
| GSK Investigational Site | Deva | 330084 | Romania |
| GSK Investigational Site | Timișoara | 300310 | Romania |
| GSK Investigational Site | Dnipropetrovsk | 49006 | Ukraine |
| GSK Investigational Site | Dnipropetrovsk | 49027 | Ukraine |
| GSK Investigational Site | Dnipropetrovsk | 49051 | Ukraine |
| GSK Investigational Site | Donetsk | 83099 | Ukraine |
| GSK Investigational Site | Ivano-Frankivsk | 76018 | Ukraine |
| GSK Investigational Site | Kharkiv | 61002 | Ukraine |
| GSK Investigational Site | Kharkiv | 61037 | Ukraine |
| GSK Investigational Site | Kharkiv | 61124 | Ukraine |
| GSK Investigational Site | Kiev | 03680 | Ukraine |
| GSK Investigational Site | Kyiv | 02232 | Ukraine |
| GSK Investigational Site | Kyiv | 03115 | Ukraine |
| GSK Investigational Site | Kyiv | 03680 | Ukraine |
| GSK Investigational Site | Kyiv | 04107 | Ukraine |
| GSK Investigational Site | Kyiv | 04201 | Ukraine |
| GSK Investigational Site | Kyiv | Ukraine |
| GSK Investigational Site | Odesa | 65114 | Ukraine |
| GSK Investigational Site | Simferopol | 95043 | Ukraine |
| GSK Investigational Site | Yalta | 98603 | Ukraine |
| GSK Investigational Site | Zaporizhia | 69035 | Ukraine |
For additional information about this study please refer to the GSK Clinical Study Register |
| 112186 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112186 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112186 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112186 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112186 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112186 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | 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]). | Posted | Least Squares Mean | Standard Error | Liters | Baseline and Week 8 |
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| 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) | ITT Population. Only those participants with analyzable data at the indicated time point were assessed. | Posted | Least Squares Mean | Standard Error | Liters per minute | Baseline up to Week 8 |
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| 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). | ITT Population. Only those participants with analyzable data at the indicated time point were assessed. | Posted | Least Squares Mean | Standard Error | Liters per minute | Baseline up to Week 8 |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | Percentage of symptom-free days | Baseline up to Week 8 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | Percentage of symptom-free nights | Baseline up to Week 8 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | Percentage of rescue-free days | Baseline up to Week 8 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | Percentage of rescue-free nights | Baseline up to Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Least Squares Mean | Standard Error | Day-time symptom scores on a scale | Baseline up to Week 8 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | Night-time symptom scores on a scale | Baseline up to Week 8 |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | Day-time number of inhalations | Baseline up to Week |
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| 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). | 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. | Posted | Least Squares Mean | Standard Error | Night-time number of inhalations | Baseline up to Week 8 |
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| 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 (%). | ITT Population. Only those participants with analyzable data at the indicated time point were assessed. | Posted | Count of Participants | Participants | Upto 8 Weeks |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 100 | 0 | 100 | 10 | 100 |
| EG001 | GSK2190915 10mg | 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. | 0 | 99 | 1 | 99 | 13 | 99 |
| EG002 | 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. | 0 | 100 | 0 | 100 | 6 | 100 |
| EG003 | 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. | 0 | 100 | 1 | 100 | 9 | 100 |
| EG004 | 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. | 0 | 101 | 0 | 101 | 9 | 101 |
| EG005 | 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. | 0 | 103 | 1 | 103 | 14 | 103 |
| EG006 | 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. | 0 | 97 | 0 | 97 | 15 | 97 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cartilage injury | Injury, poisoning and procedural complications | 14.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | 14.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | 14.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 14.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | 14.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| C552410 | 3-(3-tert-butylsulfanyl-1-(4-(6-ethoxypyridin-3-yl)benzyl)-5-(5-methylpyridin-2-ylmethoxy)-1H-indol-2-yl)-2,2-dimethylpropionic acid |
| C093875 | montelukast |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG006 | 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. |
| ANCOVA | ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data. | 0.066 | The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg). | Mean Difference (Net) | 0.104 | 2-Sided | 95 | -0.01 | 0.22 | Superiority or Other |
| ANCOVA | ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data. | 0.224 | The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg). | Mean Difference (Net) | 0.069 | 2-Sided | 95 | -0.04 | 0.18 | Superiority or Other |
| ANCOVA | ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data. | 0.271 | The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg). | Mean Difference (Net) | 0.062 | 2-Sided | 95 | -0.05 | 0.17 | Superiority or Other |
| ANCOVA | ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data. | <0.001 | The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg). | Mean Difference (Net) | 0.189 | 2-Sided | 95 | 0.08 | 0.30 | Superiority or Other |
| ANCOVA | ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data. | 0.220 | The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg). | Mean Difference (Net) | 0.070 | 2-Sided | 95 | -0.04 | 0.18 | Superiority or Other |
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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
|
|
|
| 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
|
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
|
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
|
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
|
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
|
|
|
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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
|
|
|
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.
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
|
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
|
|
|
| OG002 | 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. |
| OG003 | GSK2190915 10 0mg | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
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| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
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