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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00920959 | Advair Pediatric Once-Daily | PHASE3 | COMPLETED | 908 | — | — | Nov 1, 2001 | Jan 1, 2004 | Sep 15, 2016 | 149 | United States, Argentina +3 |
| NCT01248975 | Safety and Efficacy Study Adding GSK2190915 to Mid-dose Inhaled Corticosteroid/Long Acting Beta Agonist Combination Treatment for Asthma | PHASE2 | COMPLETED | 145 | — | — | Dec 1, 2010 | Oct 1, 2011 | Nov 25, 2016 | 19 | Bulgaria, Poland +1 |
| Arm | Type | Description |
|---|---|---|
| Fluticasone propionate/salmeterol combination | EXPERIMENTAL | study drug |
| Fluticasone propionate | EXPERIMENTAL | study drug |
| Placebo | EXPERIMENTAL | placebo |
| FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM) | EXPERIMENTAL | FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM) |
| FP/SAL 250/50mcg BID plus montelukast 10mg QD (PM) | ACTIVE_COMPARATOR | FP/SAL 250/50mcg BID plus montelukast 10mg QD (PM) |
| FP/SAL 250/50mcg BID plus placebo BID | PLACEBO_COMPARATOR | P/SAL 250/50mcg BID plus placebo BID |
| Name | Type | Description |
|---|---|---|
| FP 100mcg | DRUG | Once-daily dosing |
| FSC 100/50mcg | DRUG | Once-daily dosing |
| Placebo | DRUG | Once-daily dosing |
| FP/SAL 250/50mcg BID | DRUG | FP/SAL 250/50mcg BID |
| GSK2190915 200mg QD (AM) | DRUG | GSK2190915 200mg QD (AM) |
| GSK2190915 100mg QD (AM) | DRUG | GSK2190915 100mg QD (AM) |
| Montelukast 10mg QD (PM) | DRUG | Montelukast 10mg QD (PM) |
| Placebo tablets (2) (AM) | DRUG | Placebo tablets (2) (AM) |
| Placebo capsule (PM) | DRUG | Placebo capsule (PM) |
Inclusion Criteria: * Out-patients * Asthma diagnosis * Reversibility * Short-acting beta-agonist or asthma controlled medication use Exclusion Criteria: * Life-threatening asthma * Specified asthma medications * Chickenpox * Drug allergy * Respiratory infections * Tobacco use * Clinical laborato...