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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01061333 | Early Airway Response to Allergen in Asthmatics (MK-0000-176) | PHASE1 | COMPLETED | 16 | — | — | Jun 1, 2010 | Mar 1, 2011 | Sep 4, 2015 | - | — |
Maximal percent drop in FEV1 at 20 minutes post allergen challenge
Fold change over baseline of plasma 9P at 5 minutes post-allergen challenge
Fold change over baseline of plasma 9P at 20 minutes post-allergen challenge
| Arm | Type | Description |
|---|---|---|
| Placebo | EXPERIMENTAL | Placebo |
| Montelukast | EXPERIMENTAL | Montelukast |
| Nedocromil | EXPERIMENTAL | Nedocromil |
| Mometasone | EXPERIMENTAL | Mometasone |
| Name | Type | Description |
|---|---|---|
| Nedocromil | DRUG | Nedocromil 4 mg, as metered dose inhaler 1 hour prior to allergen challenge |
| Comparator: Montelukast | DRUG | Montelukast single 10 mg tablet administered 2 hours prior to allergen challenge |
| Comparator: Mometasone | DRUG | Mometasone furoate 400 mcg by twisthaler, administered 2 hours prior to allergen challenge |
| Placebo | DRUG | Mometasone placebo twisthaler, Nedocromil placebo metered dose inhaler, Montelukast placebo tablet |
Inclusion Criteria: * History of mild to moderate Asthma * In good general health (except for asthma) * Stable and free of respiratory infection * Nonsmoker * Females highly unlikely to conceive (surgically sterilized, postmenopausal, or agrees to use 2 acceptable methods of birth control) Exclusi...