Patient-reported symptoms and use of as-needed salbutamol over 12 weeks
| Study 1 | Study 2 | |||
| Indacaterol + tiotropium | Tiotropium + placebo | Indacaterol + tiotropium | Tiotropium + placebo | |
| Baseline* symptom score† | ||||
| Full 24 h | 11.9 (5.98) | 10.8 (5.77) | 11.6 (5.91) | 11.7 (5.42) |
| Daytime | 6.2 (2.97) | 5.7 (2.90) | 6.1 (2.94) | 6.1 (2.71) |
| Night-time | 5.6 (3.16) | 5.2 (3.03) | 5.5 (3.06) | 5.5 (2.86) |
| Change from baseline symptom score (full 24 h) during treatment | −2.1 (0.20) | −1.6 (0.21) | −2.2 (0.21) | −1.5 (0.21) |
| Difference between treatments | −0.5 (−0.9 to −0.08) | −0.6 (−1.1 to −0.2) | ||
| Change from baseline symptom score (daytime) during treatment | −1.2 (0.10) | −0.9 (0.10) | −1.1 (0.12) | −0.8 (0.12) |
| Difference between treatments | −0.3 (−0.5 to −0.06) | −0.4 (−0.6 to −0.1) | ||
| Change from baseline symptom score (night-time) during treatment | −1.0 (0.10) | −0.8 (0.10) | −1.0 (0.12) | −0.7 (0.12) |
| Difference between treatments | −0.2 (−0.4 to −0.03) | −0.3 (−0.5 to −0.1) | ||
| Baseline† salbutamol use (puffs/day) | 5.5 (4.24) (n=538) | 5.0 (4.45) (n=538) | 4.9 (3.91) (n=555) | 4.5 (3.97) (n=543) |
| Change from baseline salbutamol use during treatment (puffs/day) | −2.5 (0.17) | −1.3 (0.17) | −2.1 (0.17) | −1.4 (0.17) |
| Difference between treatments | −1.1 (−0.8 to −1.5) | −0.7 (−1.0 to −0.4) | ||
| Days during baseline† with no salbutamol use (%) | 16.1 (30.95) (n=532) | 21.9 (35.35) (n=521) | 14.4 (28.64) (n=545) | 19.3 (32.55) (n=536) |
| Days during treatment with no salbutamol use (%) | 43.2 (1.91) | 34.2 (1.93) | 38.7 (1.94) | 33.6 (1.92) |
| Difference between treatments | 9.0 (5.1 to 12.8) | 5.1 (1.4 to 8.8) | ||
Baseline values are raw means (SD). Changes from baseline are least square means (SE) and treatment comparisons are least square means (95% CI).
All treatment contrasts significant at p<0.03.
↵* Measured during 14-day run-in.
↵† Composite of scores for cough, wheeze, sputum production/colour and breathlessness, each measured twice daily on a four-point scale of increasing severity.