Secondary outcomes in COPD patients 3 and 6 months after an inhaled corticosteroid or placebo
| Outcome measure | Baseline5-150 (after prednisone) | At 3 months change from baseline5-151 | Treatment difference5-151 | At 6 months change from baseline5-151 | Treatment difference5-151 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Budesonide (n=39) | Placebo (n=40) | Budesonide (n=38) | Placebo (n=34) | Budesonide (n=36) | Placebo (n=30) | ||||||||
| Exercise capacity: | |||||||||||||
| 6-min walking test5-152 (m) | 311 (61) | 272 (59) | −22 (−35 to −8) | −6 (−21 to 8) | −16 (−35 to 4) | −15 (−26 to −3) | 13 (−1.0 to 27) | −28 (−45 to −10) | |||||
| Dyspnoea with exertion5-153 (m) | 5.1 (1.7) | 5.6 (1.9) | 0.8 (0 to 1.6) | 1.0 (0.3 to 1.8) | −0.2 (−1.3 to 0.8) | 0.7 (−0.1 to 1.5) | 0.6 (−0.1 to 1.4) | 0.1 (−1.0 to 1.1) | |||||
| Quality of life5-155: | |||||||||||||
| Dyspnoea | 19.9 (6.2) | 19.5 (5.8) | −1.7 (−3.0 to 0.5) | −0.8 (−3.7 to 2.2) | −0.9 (−4.4 to 2.5) | −1.8 (−3.9 to 0.2) | −0.5 (−2.3 to −1.3) | −1.3 (−4.1 to 1.5) | |||||
| Emotion | 37.9 (6.9) | 36.2 (9.6) | 1.1 (−1.2 to 3.5) | −1.3 (−4.3 to 1.8) | 2.4 (−1.3 to 6.0) | −1.9 (−5.3 to 1.4) | −0.6 (−3.4 to 2.2) | −1.3 (−5.7 to 3.1) | |||||
| Fatigue | 20.7 (3.6) | 19.3 (5.6) | −1.6 (−3.2 to 0) | −1.8 (−3.7 to 0.2) | 0.2 (−2.2 to 2.6) | −3.0 (−4.9 to −1.2) | −1.4 (−3.1 to 0.3) | −1.6 (−4.1 to 0.9) | |||||
| Mastery | 21.4 (4.2) | 21.7 (5.8) | 0.5 (−1.1 to 2.1) | −1.4 (−3.2 to 0.3) | 1.9 (−0.4 to 4.2) | −0.5 (−2.4 to 1.4) | −1.3 (−3.0 to 0.5) | 0.8 (−1.8 to 3.4) | |||||
↵5-150 Values presented are the mean and SD in parentheses.
↵5-151 Values presented are the mean and the 95% CI in parentheses.
↵5-152 Values presented are the maximum distance that the patient can walk in 6 min.
↵5-153 Dyspnoea was assessed immediately after the 6-min walking test using a 10-cm VAS anchored by the terms “extremely short of breath” (a score of 0) and “no shortness of breath” (a score of 10).
↵5-155 Scores for quality of life are from worst to best: dyspnoea, 5 to 35; fatigue, 4 to 28; emotion, 7 to 49; mastery, 4 to 28.