Secondary efficacy outcomes
| At 10 weeks after randomisation | At 26 weeks after randomisation | |||||||
|---|---|---|---|---|---|---|---|---|
| Outcome | Placebo (N=45–50)Mean (SD) | Azithromycin (N=50–53)Mean (SD) | DifferenceMean (95% CI) | p Value | Placebo (N=45–50)Mean (SD) | Azithromyc0in (N=47–53)Mean (SD) | DifferenceMean (95% CI) | p Value |
| Change in ACQ score, baseline to week 10 or 26 | −0.04 (0.76) | −0.05 (0.98) | −0.01 (−0.35 to 0.33) | 0.940 | −0.12 (0.70) | −0.24 (0.93) | −0.12 (−0.44 to 0.21) | 0.485 |
| Change in AQLQ total score, baseline to week 10 or 26 | 0.15 (0.63) | 0.24 (0.84) | 0.09 (−0.19 to 0.38) | 0.509 | 0.20 (0.73) | 0.32 (0.89) | 0.12 (−0.20 to 0.44) | 0.467 |
| Absolute change in morning PEF, baseline to week 10 or 26 (l/min) | −1.72 (49.97) | −3.30 (42.10) | −1.58 (−20.08 to 16.92) | 0.866 | −5.77 (48.20) | −1.81 (45.27) | 3.96 (−15.40 to 23.32) | 0.686 |
| Absolute change in evening PEF, baseline to week 10 or 26 (l/min) | −7.98 (44.66) | −4.11 (36.10) | 3.88 (−12.38 to 20.13) | 0.637 | −4.65 (78.68) | −0.81 (48.47) | 3.84 (−23.10 to 30.78) | 0.778 |
| Change in pre-BD FEV1, baseline to week 10 or 26 (%) | 0.92 (9.88) | 0.64 (9.99) | −0.28 (−4.11 to 3.54) | 0.884 | −0.90 (11.79) | −0.02 (10.06) | 0.88 (−3.44 to 5.19) | 0.688 |
| Change in post-BD FEV1, baseline to week 10 or 26 (%) | 1.17 (8.88) | 0.91 (7.61) | −0.26 (−3.45 to 2.92) | 0.870 | −0.66 (8.84) | 1.29 (12.50) | 1.95 (−2.42 to 6.33) | 0.378 |
| Change in use of rescue medication (number of puffs per day) | 0.26 (2.19) | 0.13 (1.18) | −0.13 (−0.83 to 0.56) | 0.706 | 0.24 (2.11) | 0.08 (1.14) | −0.16 (−0.88 to 0.55) | 0.655 |
| Change in FeNO (ppb), median (Q1; Q3) | 2 (−4.5; 5.0) | 0 (−4.5; 7.1) | −2 | 0.676 | 2.1 (−4.2; 6.0) | 0.5 (−6.7; 6.7) | −1.6 | 0.666 |
ACQ, Asthma Control Questionnaire; AQLQ, Asthma Quality of Life Questionnaire; BD, bronchodilator; FeNO, fraction of exhaled nitric oxide; FEV1, forced expiratory volume in 1 s; PEF, peak expiratory flow.