Table 2 Results for primary, secondary and selected other endpoints (intent-to-treat population)
Endpoint | Placebo OD PM (N = 111) | FF 50 mcg OD PM (N = 111) | ||||
|---|---|---|---|---|---|---|
n | Mean (SE) | n | Mean (SE) | Difference (95% CI) | ||
Pre-dose evening FEV1a, L | Primary | 106 | 0.038 (0.0333) | 108 | 0.157 (0.0330) | 0.120* (0.026, 0.213) |
Rescue-free 24-h periodsb, % | Secondary (powered) | 110 | 17.1 (2.78) | 111 | 28.7 (2.77) | 11.6*(3.8, 19.4) |
Evening PEFb, L/min | Secondary | 110 | 19.5 (3.72) | 111 | 22.8 (3.70) | 3.3 (−7.2, 13.7) |
Morning PEFb, L/min | Secondary | 110 | 22.9 (3.65) | 111 | 34.5 (3.64) | 11.6 (1.4, 21.9) |
Symptom-free 24-h periodsb, % | Secondary | 110 | 14.0 (2.49) | 111 | 22.6 (2.47) | 8.6 (1.6, 15.6) |
Number of patients | Number of patients | |||||
Withdrawal due to lack of efficacyb, % | Secondary | 14 | 6 | |||
n | Mean (SE) | n | Mean (SE) | Difference (95% CI) | ||
Asthma Control Test™ (ACT) scorea | Other | 92 | 4.0 (0.39) | 100 | 6.2 (0.38) | 2.2 (1.1, 3.3) |
n | Number of patients | n | Number of patients | Odds Ratio (95% CI) | ||
Patients with ACT score ≥20a, % | Other | 92 | 55 | 100 | 69 | 1.88 (0.97, 3.65) |
n | Mean (SE) | n | Mean (SE) | Difference (95% CI) | ||
Total Asthma Quality of Life Questionnaire (AQLQ) + 12 scorea | Other | 92 | 0.84 (0.097) | 100 | 1.30 (0.093) | 0.45 (0.18, 0.72) |