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The primary objective of this study is to evaluate the efficacy and safety of adding GSK2190915 100mg, GSK2190915 300mg or placebo tablets administered once daily to fluticasone propionate 100mcg inhalation administered twice daily in uncontrolled asthmatic subjects > or = 12 years of age over the course of 6 weeks treatment.
The secondary objectives are to undertake an exploratory analysis of the efficacy and safety of adding montelukast 10mg administered once daily or salmeterol 50mcg administered twice daily to fluticasone propionate 100mcg inhalation administered twice daily and to investigate the pharmacokinetics and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects > or = 12 years of age over the course of 6 weeks treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FP 100mcg BID plus GSK2190915 100mg QD (AM) | Experimental | FP 100mcg BID plus GSK2190915 100mg QD (AM) |
|
| FP 100mcg BID plus GSK2190915 300mg QD (AM) | Experimental | FP 100mcg BID plus GSK2190915 300mg QD (AM) |
|
| FP 100mcg BID plus montelukast 10mg QD (PM) | Active Comparator | FP 100mcg BID plus montelukast 10mg QD (PM) |
|
| FP 100mcg BID plus placebo BID | Active Comparator | FP 100mcg BID plus placebo BID |
|
| FP/SAL 100/50mcg BID plus placebo BID | Active Comparator | FP/SAL 100/50mcg BID plus placebo BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FP 100 | Drug | FP 100mcg BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically using spirometry, prior to study medication and any rescue albuterol (bronchodilator) use. At the end of the 6-week treatment period, FEV1 was measured approximately 24 hours after the participant's last morning dose of study medication and approximately 12 hours after the evening dose of study medication. Trough FEV1 was analyzed using mixed effect analysis of covariance (ANCOVA) model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effect of participant. Intent-to-Treat Population is defined as all participants who were randomized and received at least one dose of study drug. | End of Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Trough (Morning Pre-dose and Pre-rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Averaged Over the Last 3 Weeks of the 6-week Treatment Period | The PEF is a measure of lung function and measures how fast a person can breathe out. Trough PEF was measured every morning prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily electronic diary (eDiary). Daily trough morning PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. |
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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 |
|---|---|---|---|
| 24010736 | Derived | Snowise NG, Clements D, Ho SY, Follows RM. Addition of a 5-lipoxygenase-activating protein inhibitor to an inhaled corticosteroid (ICS) or an ICS/long-acting beta-2-agonist combination in subjects with asthma. Curr Med Res Opin. 2013 Dec;29(12):1663-74. doi: 10.1185/03007995.2013.842163. Epub 2013 Sep 19. |
| 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 |
|---|---|---|---|
| 114255 | Statistical Analysis Plan | 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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Par. meeting screening criteria, self-administered open-label fluticasone propionate 100 micrograms (µg) twice daily for 14-28 days. Eligible par. were assigned to 1 of 10 treatment sequences, receiving 4 of 5 double-blind treatments. Par. aged 12-14 years did not receive montelukast. Rescue medication (albuterol inhalation) was provided.
A total of 341 participants (par.) were screened, and 162 participants were randomized. A protocol amendment necessitated withdrawal of all male participants and further enrollment of female participants only.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Treatments Combined | In a total of 4 treatment periods (each of 6 weeks - the first 3 weeks considered as active washout), participants received 4 of the 5 possible treatments (A/B/C/D/E) in a double-blind double-dummy, cross-over manner. Fluticasone propionate (FP) 100 µg oral inhalation was a part of each treatment. Added regimen were, A: GSK2190915 100 milligrams (mg) once daily (OD), B: GSK2190915 300 mg OD, C: montelukast 10 mg OD, D: placebo twice daily (BID), E: salmeterol 50 µg and placebo BID. Albuterol aerosol was provided as a rescue inhalation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| GSK2190915 100 | Drug | GSK2190915 100mg QD (AM) |
|
| GSK2190915 300 | Drug | GSK2190915 300mg QD (AM) |
|
| montelukast | Drug | montelukast 10mg QD (PM) |
|
| placebo | Drug | placebo BID |
|
| FP/SAL 100/50 | Drug | FP/SAL 100/50mcg BID |
|
| Week 4 to Week 6 |
| Daily Evening PEF Averaged Over the Last 3 Weeks of the 6-week Treatment Period | The PEF is a measure of lung function and measures how fast a person can breathe out. PEF was measured every evening prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily eDiary. Daily evening PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. | Week 4 to Week 6 |
| Daily (Average of Morning and Evening) PEF Averaged Over the Last 3 Weeks of the 6 -Week Treatment Period Between GSK2190915 and Montelukast Groups | The PEF is a measure of lung function and measures how fast a person can breathe out. PEF was measured every morning and evening prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily eDiary. Daily average of morning and evening PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. This outcome measure explored the efficacy between GSK2190915 and montelukast due to the dosing time difference. | Week 4 to Week 6 |
| Daily Asthma Symptom Score Averaged Over the Last 3 Weeks of the 6-week Treatment Period | Daytime and night time asthma symptoms were recorded every evening at bedtime and every morning upon rising, respectively, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on scales ranging from '0' (implying no symptoms) to either 5 (for daytime symptoms) or 4 (for night time symptoms) (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. 24-hour period asthma symptom scores were averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. | Week 4 to Week 6 |
| Daily Rescue Short-acting beta2-agonist (SABA) Use Averaged Over the Last 3 Weeks of the 6-week Treatment Period | A SABA (albuterol) was provided to participants as a rescue medication, to use as needed for symptomatic relief of asthma symptoms. Participants were required to record their albuterol use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The daily rescue SABA use was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. | Week 4 to Week 6 |
| Percentage of Symptom-free Days During the Last 3 Weeks of the 6-week Treatment Period | Daytime asthma symptoms were recorded every evening at bedtime, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 6-point scale ranging from '0' (implying no symptoms) to 5 (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. The number of days when symptoms were not experienced ("symptom-free days") during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. | Week 4 to Week 6 |
| Percentage of Symptom-free Nights During the Last 3 Weeks of the 6 Week Treatment Period | Night time asthma symptoms were recorded every morning upon rising, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 5-point scale ranging from '0' (implying no symptoms) to 4 (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. The number of nights when symptoms were not experienced ("symptom-free nights") during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. | Week 4 to Week 6 |
| Percentage of Rescue-free Days During the Last 3 Weeks of the 6-week Treatment Period | Albuterol was provided as a rescue medication, and participants were required to record rescue medication use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The number of days when rescue medication was not used ("rescue-free days") during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. | Week 4 to Week 6 |
| Percentage of Rescue-free Nights During the Last 3 Weeks of the 6-week Treatment Period | Albuterol was provided as a rescue medication, and participants were required to record rescue medication use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The number of nights when rescue medication was not used ("rescue-free nights") during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. | Week 4 to Week 6 |
| Percentage of Nights Without Awakenings Due to Asthma During the Last 3 Weeks of the 6-week Treatment Period | Night time asthma symptoms were recorded every morning upon rising, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 5-point scale: 0 = no symptoms during the night, 1 = symptoms causing to wake once, 2 = symptoms causing to wake twice or more, 3 = symptoms causing to be awake most of the night, 4 = could not sleep due to severe symptoms. Participants recorded the symptoms in a daily eDiary. The number of nights with no awakenings due to asthma during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. | Week 4 to Week 6 |
| Number of Participants Withdrawn Due to Lack of Efficacy During the Last 3 Weeks of the 6-week Treatment Period | Participants were withdrawn if they met any of the following three criteria for 'lack of efficacy': 1) Clinic FEV1 below the FEV1 'Stability Limit' value, 2) During any consecutive 7-day period, the participant experienced PEF fallen below the PEF 'Stability Limit' for more than 3 days, or if >= 12 inhalations per day of albuterol were used for more than 2 days, and 3) Ashtma exacerbation. The number of withdrawals due to lack of efficacy were summarized for each treatment and Fisher's Exact test was used for comparison with placebo add-on. Withdrawals occurring during active washout periods are not included. | Week 4 to Week 6 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| GSK Investigational Site | Huntington Beach | California | 92647 | United States |
| GSK Investigational Site | Los Angeles | California | 90048 | United States |
| GSK Investigational Site | Vista | California | 92083 | United States |
| GSK Investigational Site | Coral Gables | Florida | 33134 | United States |
| GSK Investigational Site | Miami | Florida | 33173 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46208 | United States |
| GSK Investigational Site | Lenexa | Kansas | 66215 | 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 | St Louis | Missouri | 63110 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Bellevue | Nebraska | 68123-4303 | United States |
| GSK Investigational Site | Ocean City | New Jersey | 07712 | United States |
| GSK Investigational Site | Wilmington | North Carolina | 28401 | United States |
| GSK Investigational Site | Canton | Ohio | 44718 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45231 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73103 | United States |
| GSK Investigational Site | Bethlehem | Pennsylvania | 18020 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15241 | United States |
| GSK Investigational Site | Orangeburg | South Carolina | 29118 | United States |
| GSK Investigational Site | Austin | Texas | 78750 | United States |
| GSK Investigational Site | Dallas | Texas | 75230 | United States |
| GSK Investigational Site | Houston | Texas | 77054 | United States |
| GSK Investigational Site | Plano | Texas | 75024 | United States |
| GSK Investigational Site | Waco | Texas | 76712 | United States |
| GSK Investigational Site | South Burlington | Vermont | 05403 | United States |
| GSK Investigational Site | Madison | Wisconsin | 53792 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114255 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114255 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114255 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114255 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114255 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114255 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Treatments Combined | In a total of 4 treatment periods (each of 6 weeks - the first 3 weeks considered as active washout), participants received 4 of the 5 possible treatments (A/B/C/D/E) in a double-blind double-dummy, cross-over manner. Fluticasone propionate (FP) 100 µg oral inhalation was a part of each treatment. Added regimen were, A: GSK2190915 100 milligrams (mg) once daily (OD), B: GSK2190915 300 mg OD, C: montelukast 10 mg OD, D: placebo twice daily (BID), E: salmeterol 50 µg and placebo BID. Albuterol aerosol was provided as a rescue inhalation. |
| 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 |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically using spirometry, prior to study medication and any rescue albuterol (bronchodilator) use. At the end of the 6-week treatment period, FEV1 was measured approximately 24 hours after the participant's last morning dose of study medication and approximately 12 hours after the evening dose of study medication. Trough FEV1 was analyzed using mixed effect analysis of covariance (ANCOVA) model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effect of participant. Intent-to-Treat Population is defined as all participants who were randomized and received at least one dose of study drug. | ITT Population. Only those participants available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | Liters (L) | End of Week 6 |
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| Secondary | Daily Trough (Morning Pre-dose and Pre-rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Averaged Over the Last 3 Weeks of the 6-week Treatment Period | The PEF is a measure of lung function and measures how fast a person can breathe out. Trough PEF was measured every morning prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily electronic diary (eDiary). Daily trough morning PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. | ITT Population. Only those participants available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | Liters/minute (L/min) | Week 4 to Week 6 |
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| Secondary | Daily Evening PEF Averaged Over the Last 3 Weeks of the 6-week Treatment Period | The PEF is a measure of lung function and measures how fast a person can breathe out. PEF was measured every evening prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily eDiary. Daily evening PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. | ITT Population. Only those participants available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | L/min | Week 4 to Week 6 |
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| Secondary | Daily (Average of Morning and Evening) PEF Averaged Over the Last 3 Weeks of the 6 -Week Treatment Period Between GSK2190915 and Montelukast Groups | The PEF is a measure of lung function and measures how fast a person can breathe out. PEF was measured every morning and evening prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily eDiary. Daily average of morning and evening PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. This outcome measure explored the efficacy between GSK2190915 and montelukast due to the dosing time difference. | ITT Population. Only those participants available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | L/min | Week 4 to Week 6 |
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| Secondary | Daily Asthma Symptom Score Averaged Over the Last 3 Weeks of the 6-week Treatment Period | Daytime and night time asthma symptoms were recorded every evening at bedtime and every morning upon rising, respectively, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on scales ranging from '0' (implying no symptoms) to either 5 (for daytime symptoms) or 4 (for night time symptoms) (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. 24-hour period asthma symptom scores were averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. | ITT Population. Only those participants available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | Score on a scale | Week 4 to Week 6 |
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| Secondary | Daily Rescue Short-acting beta2-agonist (SABA) Use Averaged Over the Last 3 Weeks of the 6-week Treatment Period | A SABA (albuterol) was provided to participants as a rescue medication, to use as needed for symptomatic relief of asthma symptoms. Participants were required to record their albuterol use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The daily rescue SABA use was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. | ITT Population. Only those participants available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | Number of inhalations | Week 4 to Week 6 |
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| Secondary | Percentage of Symptom-free Days During the Last 3 Weeks of the 6-week Treatment Period | Daytime asthma symptoms were recorded every evening at bedtime, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 6-point scale ranging from '0' (implying no symptoms) to 5 (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. The number of days when symptoms were not experienced ("symptom-free days") during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. | ITT Population. Only those participants available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | Percentage of days | Week 4 to Week 6 |
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| Secondary | Percentage of Symptom-free Nights During the Last 3 Weeks of the 6 Week Treatment Period | Night time asthma symptoms were recorded every morning upon rising, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 5-point scale ranging from '0' (implying no symptoms) to 4 (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. The number of nights when symptoms were not experienced ("symptom-free nights") during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. | ITT Population. Only those participants available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | Percentage of nights | Week 4 to Week 6 |
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| Secondary | Percentage of Rescue-free Days During the Last 3 Weeks of the 6-week Treatment Period | Albuterol was provided as a rescue medication, and participants were required to record rescue medication use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The number of days when rescue medication was not used ("rescue-free days") during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. | ITT Population. Only those participants available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | Percentage of days | Week 4 to Week 6 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Rescue-free Nights During the Last 3 Weeks of the 6-week Treatment Period | Albuterol was provided as a rescue medication, and participants were required to record rescue medication use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The number of nights when rescue medication was not used ("rescue-free nights") during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. | ITT Population. Only those participants available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | Percentage of nights | Week 4 to Week 6 |
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| Secondary | Percentage of Nights Without Awakenings Due to Asthma During the Last 3 Weeks of the 6-week Treatment Period | Night time asthma symptoms were recorded every morning upon rising, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 5-point scale: 0 = no symptoms during the night, 1 = symptoms causing to wake once, 2 = symptoms causing to wake twice or more, 3 = symptoms causing to be awake most of the night, 4 = could not sleep due to severe symptoms. Participants recorded the symptoms in a daily eDiary. The number of nights with no awakenings due to asthma during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. | ITT Population. Only those participants available at the specified time point were analyzed. | Posted | Least Squares Mean | Standard Error | Percentage of nights | Week 4 to Week 6 |
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| Secondary | Number of Participants Withdrawn Due to Lack of Efficacy During the Last 3 Weeks of the 6-week Treatment Period | Participants were withdrawn if they met any of the following three criteria for 'lack of efficacy': 1) Clinic FEV1 below the FEV1 'Stability Limit' value, 2) During any consecutive 7-day period, the participant experienced PEF fallen below the PEF 'Stability Limit' for more than 3 days, or if >= 12 inhalations per day of albuterol were used for more than 2 days, and 3) Ashtma exacerbation. The number of withdrawals due to lack of efficacy were summarized for each treatment and Fisher's Exact test was used for comparison with placebo add-on. Withdrawals occurring during active washout periods are not included. | ITT Population. | Posted | Number | Number of participants | Week 4 to Week 6 |
|
On-treatment adverse events (AE) and serious adverse events (SAE) were collected from the start of treatment until the follow-up contact (a maximum of 178 days).
On-treatment AEs and SAEs are reported for 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 | FP + Placebo | Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation. | 0 | 104 | 8 | 104 | ||
| EG001 | FP + GSK2190915 100 mg | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. | 1 | 103 | 3 | 103 | ||
| EG002 | FP + GSK2190915 300 mg | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. | 0 | 96 | 4 | 96 | ||
| EG003 | FP + Montelukast | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation. | 0 | 99 | 1 | 99 | ||
| EG004 | FP / Salmeterol | Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. | 0 | 104 | 1 | 104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA 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 |
|---|---|
| C093875 | montelukast |
Not provided
Not provided
Not provided
| Asian - Central/South Asian Heritage |
|
| White - White/Caucasian/European Heritage |
|
| Mixed Race |
|
| Missing |
|
| Mean Difference (Final Values) |
| 0.042 |
| 2-Sided |
| 95 |
| -0.00 |
| 0.09 |
| Superiority or Other |
| Mixed Models Analysis | =0.017 | Mean Difference (Final Values) | 0.056 | 2-Sided | 95 | 0.01 | 0.10 | Superiority or Other |
| Mixed Models Analysis | =0.002 | Mean Difference (Final Values) | 0.074 | 2-Sided | 95 | 0.03 | 0.12 | Superiority or Other |
| OG002 | FP + GSK2190915 300 mg | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. |
| OG003 | FP + Montelukast | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation. |
| OG004 | FP / Salmeterol | Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. |
|
|
|
| OG002 | FP + GSK2190915 300 mg | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. |
| OG003 | FP + Montelukast | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation. |
| OG004 | FP / Salmeterol | Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. |
|
|
|
| OG002 | FP + Montelukast | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation. |
|
|
|
| OG002 | FP + GSK2190915 300 mg | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. |
| OG003 | FP + Montelukast | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation. |
| OG004 | FP / Salmeterol | Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. |
|
|
|
| OG002 | FP + GSK2190915 300 mg | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. |
| OG003 | FP + Montelukast | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation. |
| OG004 | FP / Salmeterol | Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. |
|
|
|
| OG002 | FP + GSK2190915 300 mg | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. |
| OG003 | FP + Montelukast | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation. |
| OG004 | FP / Salmeterol | Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. |
|
|
|
| OG002 | FP + GSK2190915 300 mg | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. |
| OG003 | FP + Montelukast | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation. |
| OG004 | FP / Salmeterol | Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. |
|
|
|
| OG002 | FP + GSK2190915 300 mg | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. |
| OG003 | FP + Montelukast | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation. |
| OG004 | FP / Salmeterol | Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. |
|
|
|
| OG002 | FP + GSK2190915 300 mg | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. |
| OG003 | FP + Montelukast | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation. |
| OG004 | FP / Salmeterol | Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. |
|
|
|
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. |
| OG002 | FP + GSK2190915 300 mg | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. |
| OG003 | FP + Montelukast | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation. |
| OG004 | FP / Salmeterol | Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. |
|
|
|
| OG002 | FP + GSK2190915 300 mg | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. |
| OG003 | FP + Montelukast | Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation. |
| OG004 | FP / Salmeterol | Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation. |
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