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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00245570 | Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction (0476-316) | PHASE3 | COMPLETED | 47 | — | — | Dec 1, 2005 | Sep 1, 2006 | Feb 2, 2022 | - | — |
In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Montelukast - Salmeterol - Placebo |
| 2 | EXPERIMENTAL | Montelukast - Placebo - Salmeterol |
| 3 | EXPERIMENTAL | Salmeterol - Montelukast - Placebo |
| 4 | EXPERIMENTAL | Salmeterol - Placebo - Montelukast |
| 5 | EXPERIMENTAL | Placebo - Montelukast - Salmeterol |
| 6 | EXPERIMENTAL | Placebo - Salmeterol - Montelukast |
| Name | Type | Description |
|---|---|---|
| Comparator: Montelukast | DRUG | 1 dose montelukast 10 mg tablet given orally in one of three treatment periods |
| Comparator: Salmeterol | DRUG | 1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods |
| Comparator: Placebo (montelukast) | DRUG | 1 dose matching-image placebo to montelukast tablet in two of three treatment periods |
| Comparator: Placebo (salmeterol) | DRUG | 1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods |
Inclusion Criteria: * Physician-diagnosed exercise-induced bronchospasm Exclusion Criteria: * Patient is, other than asthma, not in good, stable health. The Primary Investigator will evaluate whether there are other reasons why the patient may not participate.