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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00666679 | Study of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma (0476-386) | PHASE2 | COMPLETED | 134 | — | — | May 1, 2008 | Feb 1, 2009 | May 10, 2024 | - | — |
To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | mometasone |
| 2 | PLACEBO_COMPARATOR | montelukast followed by placebo; or placebo followed by montelukast. |
| Name | Type | Description |
|---|---|---|
| Comparator: mometasone | DRUG | mometasone (inhalation powder, 220 mcg once-daily, for approximately 6 weeks) |
| Comparator: montelukast | DRUG | montelukast (inhalation powder, 1 mg once-daily, for approximately 2 weeks) |
| Comparator: placebo (unspecified) | DRUG | Placebo (Placebo once-daily, for approximately 2 weeks) |
Inclusion Criteria: * Patient has decreased breathing capacity (when not taking asthma medicine) that improves after taking a fast-acting asthma inhaler * Within one month of the first study visit, patient has been treated with a fast-acting asthma inhaler, and may be treated with a corticosteroid ...