Table 2 Mean (SD) changes in FEV1 and FVC % predicted in the azithromycin and placebo groups during the study.
Azithromycin | Placebo | Azithromycin−placebo difference estimate (95% CI) | |
---|---|---|---|
FEV1 % predicted (%) | |||
Trend slope over the 12 months | |||
Total population | −4.9 (2.0) | −1.7 (2.0) | −3.2 (−8.9 to 2.3), NS |
Patients not infected with PA | −5.0 (2.5) | −1.8 (2.4) | −3.2 (−10.0 to 3.6), NS |
Patients infected with PA | −4.1 (3.2) | −1.2 (3.1) | −2.9 (−11.7 to 5.8), NS |
Relative change | |||
Total population | −4.3 (17.9) | −1.5 (15.4) | −2.8 (−10.1 to 4.5), NS |
Patients not infected with PA | −3.0 (19.3) | −1.1 (13.5) | −1.9 (−10.3 to 6.5), NS |
Patients infected with PA | −8.7 (11.5) | −2.7 (21.0) | −6.0 (−22.7 to 10.7), NS |
FVC % predicted (%) | |||
Trend slope over the 12 months | |||
Total population | −2.4 (1.7) | −3.6 (1.7) | 1.2 (−3.4 to 5.8), NS |
Patients not infected with PA | −2.2 (1.9) | −5.1 (1.9) | 2.9 (−2.3 to 8.2), NS |
Patients infected with PA | −3.2 (3.3) | 2.2 (3.2) | −5.4 (−14.5 to 3.7), NS |
Relative change | |||
Total population | −1.8 (13.6) | −4.5 (12.1) | 2.7 (−3.0 to 8.4), NS |
Patients not infected with PA | −1.0 (13.3) | −4.3 (9.2) | 3.3 (−2.4 to 9.1), NS |
Patients infected with PA | −4.3 (15.4) | −4.9 (19.4) | 1.0 (−16.6 to 17.6), NS |
CI, confidence interval; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; PA, Pseudomonas aeruginosa; NS, not significant; SD, standard deviation.
Sample sizes in the azithromycin and placebo groups were, respectively, 40 and 42 for the total population, 31 and 32 for patients not infected with PA, and 9 and 10 for patients infected with PA.