Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01156792 | Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age | PHASE2 | COMPLETED | 162 | — | — | Sep 1, 2010 | Oct 1, 2011 | Apr 5, 2017 | 32 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| FP 100 | DRUG | FP 100mcg BID |
| 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 |
Inclusion Criteria: * Age: 12 years of age or older * Non-, former or current smokers with a documented smoking history of ≤ 10 pack years * Asthma diagnosis as defined by the National Institutes of Health * Best FEV1 of 50% to \<80% of the predicted normal value * Post-albuterol FEV1/FVC ratio of ...