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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00284856 | Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED) | PHASE3 | COMPLETED | 1,640 | — | — | May 1, 2006 | Apr 1, 2010 | May 10, 2024 | - | — |
An asthma-control day, computed from daily diaries, was any day with no unscheduled visit for asthma care, no use of \> than 2 puffs of β-agonist, no use of other asthma rescue medication, and no nocturnal awakening. The percentage of asthma-control days was the number of days with asthma-control divided by the total number of days with non-missing values for this endpoint. The patient diary had questions concerning daytime and nighttime symptoms, morning (AM) and evening (PM) peak expiratory flow rate (PEFR), β-agonist use, asthma attacks and smoking activity.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Arm 1: Montelukast |
| 2 | ACTIVE_COMPARATOR | Arm 2: Fluticasone |
| 3 | PLACEBO_COMPARATOR | Arm 3: Placebo |
| Name | Type | Description |
|---|---|---|
| montelukast sodium | DRUG | montelukast 10 mg tablet once daily, 6 month treatment period |
| Comparator: Placebo | DRUG | fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period |
| Comparator: fluticasone | DRUG | fluticasone propionate 250 mcg twice daily, 6 month treatment period |
Inclusion Criteria: * Participants with chronic asthma who actively smoke at least 0.5 to no more than 2 packs of cigarettes a day Exclusion Criteria: * Participant cannot have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or emphysema.