Results for efficacy end points without baseline values
| End point | Placebo (n=308) | Montelukast 10 mg (n=317) | Effect difference | p value* |
|---|---|---|---|---|
| All patients were also receiving inhaled budesonide by Turbuhaler 400–1600 μg/day. | ||||
| *p value is for the montelukast v placebo. | ||||
| Nocturnal awakenings represent the percentage of patients who awoke during the night because of asthma. | ||||
| LS = least square. | ||||
| Median (95% CI) asthma exacerbation days (%) | 4.8% (3.5 to 6.3) | 3.1% (2.0 to 4.2) | 1.7% (1.2 to 6.3) | 0.03 |
| Median (95% CI) asthma free days (%) | 42.3% (32.7 to 51.2) | 66.1% (57.4 to 73.8) | 23.8% (10.9 to 41.2) | 0.001 |
| LS mean (95% CI) nocturnal awakenings (%) | 32.2% (25.9 to 38.5) | 25.6% (19.3 to 31.9) | 6.6% (1.9 to 13.7) | 0.01 |
| Discontinuation because of asthma, n (%) | 3 (1%) | 3 (1%) | 0% | 1.00 |