EMBRACE: New Zealand | BLESS: Australia | BAT: Netherlands | ||||
Placebo | Azithromycin 500 mg three times per week | Placebo | Erythromycin 400 mg twice daily | Placebo | Azithromycin 250 mg once daily | |
Subjects n | 70 | 71 | 58 | 59 | 40 | 43 |
Male % | 29 | 32 | 43 | 36 | 30 | 42 |
Mean age years | 59.0 | 60.9 | 63.5 | 61.1 | 64.6 | 59.9 |
Baseline data | ||||||
FEV1 % predicted at baseline | 67.3 | 67.1 | 70.1 | 66.9 | 82.7 | 77.7 |
Exacerbation rate pre-trial | 3.93 (mean) | 3.34 (mean) | Not reported | Not reported | 4.0 (median) | 5.0 (median) |
SGRQ | 36.6 | 31.9 | 38.1 | 36.7 | 40.2 | 40.6 |
Outcomes | ||||||
Change in FEV1 with treatment | −0.04 | 0 | −4.0 | −1.6# | −0.10 | 1.03# |
Change in SGRQ from baseline | −1.92 | −5.17 | −1.3 | −3.9 | −4.12 | −12.18# |
Total exacerbations in 12 months during trial n | 178 | 109 | 114 | 76 | 78 | 39 |
Mean exacerbation rate during trial (per patient) | 2.54 | 1.54¶ | 1.97 | 1.27# | 1.95 | 0.91¶ |
SGRQ: St. George's Respiratory Questionnaire. #: p<0.05 compared with placebo. ¶: p<0.001 compared with placebo group.