Table 2.
Efficacy Results for Continuous Outcomes.*
| Outcome | Treatment (N = 227) | Placebo (N = 244) |
|---|---|---|
| Mean (95% CI) | ||
| Change in questionnaire results from baseline to week 12 | ||
| SGRQ score | −7.7 (−9.4 to −5.9) | −8.9 (−10.6 to −7.2) |
| CAT score | −4.8 (−5.8 to −3.9) | −4.5 (−5.4 to −3.5) |
| TDI score† | 0.93 (0.59 to 1.27) | 0.92 (0.59 to 1.26) |
| Change in pulmonary function from baseline to week 12 | ||
| Inspiratory capacity — liters | 0.12 (0.07 to 0.18) | 0.02 (−0.03 to 0.08) |
| FEV1 — liters | 0.04 (0.01 to 0.08) | −0.01 (−0.04 to 0.02) |
| Percent of predicted FEV1 — percentage points | 2.48 (1.49 to 3.47) | −0.09 (−1.06 to 0.89) |
| FEF25–75 — liters/sec | 0.07 (0.00 to 0.15) | −0.08 (−0.15 to 0.00) |
| AUC0–3hr for FEV1 at week 12 — liters | 8.09 (7.99 to 8.20) | 7.82 (7.72 to 7.92) |
| Outcomes from daily diary — % of days | ||
| Any symptoms or use of albuterol | 67.0 (59.0 to 75.0) | 63.6 (55.7 to 71.5) |
| Shortness of breath | 30.7 (23.6 to 37.7) | 32.5 (25.6 to 39.4) |
| Chest tightness | 21.2 (15.0 to 27.4) | 23.5 (17.4 to 29.6) |
| Wheezing | 23.5 (17.8 to 29.2) | 24.3 (18.7 to 29.8) |
| Cough | 53.1 (45.9 to 60.2) | 48.0 (41.1 to 54.9) |
| Sputum | 45.1 (37.7 to 52.5) | 43.4 (36.1 to 50.6) |
| Use of albuterol | 9.3 (5.0 to 13.6) | 9.7 (5.5 to 14.0) |
Participants received indacaterol (27.5 μg) plus glycopyrrolate (15.6 μg) or placebo twice daily for 12 weeks. Means and 95% confidence intervals are based on linear mixed-effects model estimates with baseline covariates set at the group mean. For all secondary and exploratory analyses, 95% confidence intervals have not been adjusted for multiplicity and therefore cannot be used in place of hypothesis tests. The results shown are for prespecified outcomes. Excluded is the FEV1 12-hour trough value at the final follow-up visit, which, although specified in the protocol, the authors judged to not truly be a “trough” given that the half-life of indacaterol–glycopyrrolate is longer than 12 hours. AUC0–3hr denotes area under the curve during the first 3 hours, and FEF25–75 forced expiratory flow between 25% and 75% of the forced vital capacity.
The TDI score is a measure of the change in dyspnea severity from the baseline value established by the BDI score; scores range from −9 to 9, with higher scores indicating greater decreases in dyspnea severity.