Table 2

Baseline characteristics of BREATHE trial participants stratified by eligibility for inclusion

CharacteristicEligible randomised participants n=336Eligible analysed participants n=297Ineligible randomised and analysed participants n=11*
Placebo arm, n (%)170 (51)142 (48)4 (36)
AZM arm, n (%)166 (49)155 (52)7 (64)
Baseline FEV1 z-score, mean (SD)−2.05 (0.72)−2.05 (0.73)−0.67 (0.38)
48-week FEV1 z-score, mean (SD)−1.95 (0.90)−1.24 (0.84)
Zimbabwe site, n (%)241 (72)219 (74)0 (0)
Malawi site, n (%)95 (28)78 (26)11 (100)
Aged 6–10, n (%)44 (13)40 (13)3 (27)
Aged 11–15, n (%)152 (45)135 (45)6 (55)
Aged 16–19, n (%)140 (42)122 (41)2 (18)
Female sex, n (%)166 (49)142 (48)4 (36)
Male sex, n (%)170 (51)155 (52)7 (64)
Baseline log10 HIV viral load, mean (SD)†2.79 (1.61)2.72 (1.59)2.32 (1.95)
Baseline suppressed HIV viral load (<1000 copies/mL), n (%)†187 (56)171 (58)7 (64)
  • *All ineligible randomised participants were analysed for the primary outcome.

  • †N=2 missing values among eligible participants were imputed in the primary analysis using chained equations.

  • AZM, azithromycin; FEV1, forced expiratory volume in 1 second.