| Randomized Placebo | Randomized Azithromycin | Open-label Azithromycin | P, Placebo vs Randomized Azithromycin | P, Placebo vs Open-Label | |
|---|---|---|---|---|---|
| Change in overall asthma symptoms, from baseline | |||||
| Week 6 | −0.60 (1.07) (n=30) | −0.15 (0.83) (n=33) | −0.88 (0.81) (n=16) | .071/.071† | .333/.428† |
| Week 12 | −0.48 (1.16) (n=23) | −0.31 ((0.74) (n=32) | −1.0 (1.37) (n=16) | .551/.580† | .223/.723† |
| Week 18 | −0.15 (1.13) (n=27) | 0.10 (0.75) (n=31) | −0.94 (1.12) (n=16) | .344/.178† | .034/.161† |
| Week 24 | −0.08 (0.95) (n=25) | −0.10 (0.96) (n=30) | −1.0 (1.17) (n=17) | .939/.599† | .012/.013† |
| Week 30 | −0.05 (1.09) (n=22) | −0.34 (1.01) (n=29) | −0.81 (1.17) (n=16) | .322/.280† | .048/.870† |
| Week 36 | −0.21 (1.14) (n=24) | −0.22 (0.70) (n=27) | −1.27 (0.70) (n=15) | .959/.942† | .001/.017† |
| Week 42 | −0.04 (0.88) (n=23) | −0.12 (0.93) (n=25) | −1.21 (0.70) (n=14) | .770/.858† | <.001/.001† |
| Week 48 | −0.10 (1.07) (n=20) | −0.07 (0.88) (n=29) | −1.07 (0.95) (n=13) | .916/.758† | .011/.067† |
| Change in AQL, from baseline | |||||
| Week 12 | 0.50 (0.95) (n=22) | 0.67 (1.10) (n=26) | 1.54 (1.91) (n=15) | .584/.682† | .067/.180† |
| Week 24 | 0.31 (1.36) (n=22) | 0.49 (1.11) (n=27) | 1.36 (1.75) (n=17) | .618/.382† | .049/.151† |
| Week 36 | 0.23 (1.02) (n=23) | 0.58 (1.04) (n=22) | 2.05 (1.40) (n=15) | .261/.342† | <.001/.001† |
| Week 48 | 0.40 (1.33) (n=19) | 0.50 (1.10) (n=25) | 1.70 (1.42) (n=13) | .784/.929† | .015/.068† |
| Change in asthma control, from baseline | |||||
| Week 6 | −0.37 (0.88) (n=30) | −0.46 (0.60) (n=33) | −1.24 (1.14) (n=16) | .634/.654† | .014/.009† |
| Week 12 | −0.41 (1.01) (n=23) | −0.40 (0.80) (n=32) | −1.38 (1.87) (n=16) | .946/.998† | .075/.324† |
| Week 18 | −0.40 (1.05) (n=27) | −0.28 (0.88) (n=31) | −1.18 (1.53) (n=16) | .637/.573† | .085/.179† |
| Week 24 | −0.37 (1.12) (n=25) | −0.34 (1.03) (n=30) | −1.35 (1.69) (n=17) | .925/.536† | .045/.034† |
| Week 30 | −0.25 (1.22) (n=22) | −0.56 (0.81) (n=29) | −1.04 (1.38) (n=16) | .307/.281† | .078/.163† |
| Week 36 | −0.39 (1.00) (n=24) | −0.39 (0.79) (n=27) | −1.63 (1.41) (n=15) | 1.000/.852† | .007/.015† |
| Week 42 | −0.22 (1.32) (n=23) | −0.38 (0.72) (n=25) | −1.42 (1.41) (n=14) | .604/.817† | .016/.068† |
| Week 48 | −0.45 (1.00) (n=20) | −0.34 (0.88) (n=29) | −1.08 (1.20) (n=13) | .692/.525† | .132/.379† |
| AQL improved ≥1 unit, n/N (%) | |||||
| Week 12 | 5/22 (23) | 11/26 (42) | 9/15 (60) | .221/.136‡ | .038/.098‡ |
| Week 24 | 6/22 (27) | 8/27 (30) | 11/17 (65) | 1.000/.745‡ | .026/.048‡ |
| Week 36 | 5/23 (22) | 6/22 (27) | 12/15 (80) | .738/.738‡ | .001/.003‡ |
| Week 48 | 4/19 (21) | 9/25 (36) | 7/13 (54) | .335/.386‡ | .072/.116‡ |
| Asthma control improved ≥1 unit, n/N (%) | |||||
| Week 6 | 6/30 (20) | 4/33 (12) | 9/16 (56) | .498 /.421‡ | .021/.010‡ |
| Week 12 | 7/23 (30) | 7/32 (22) | 11/16 (69) | .539/.531‡ | .025/.045‡ |
| Week 18 | 7/27 (26) | 4/31 (13) | 9/16 (56) | .315/.437‡ | .059/.054‡ |
| Week 24 | 6/25 (24) | 10/30 (33) | 10/17 (59) | .556/.144‡ | .029/.017‡ |
| Week 30 | 5/22 (23) | 9/29 (31) | 8/16 (50) | .546/.502‡ | .098/.105‡ |
| Week 36 | 5/24 (21) | 6/27 (22) | 10/15 (67) | 1.000/.875‡ | .007/.009‡ |
| Week 42 | 6/23 (26) | 7/25 (28) | 8/14 (57) | 1.000/.862‡ | .085/.152‡ |
| Week 48 | 5/20 (25) | 8/29 (28) | 5/13 (38) | 1.000/.980‡ | .461/.998‡ |
All values are mean (SD) unless otherwise indicated.
↵* See Methods for definitions.
↵† Univariate (t test)/multivariate (analysis of variance); controlled for age, sex, and ever-smoking at each time point, as well as for controller medication use at weeks 12, 24, 36, and 48 (controller data is unavailable for other time points).
↵‡ Univariate (Fisher exact test)/multivariate (logistic regression); controlled for age, sex, and ever-smoking at each time point, as well as for controller medication use at weeks 12, 24, 36, and 48 (controller data is unavailable for other time points).
AQL, asthma quality of life.