Baseline characteristics for the intention-to-treat (ITT, n=46) and Completer (Comp, n=33) populations, by treatment allocation group
| Baseline characteristic | ITT azithromycin n=23 | ITT placebo n=23 | Comp azithromycin n=16 | Comp placebo n=17 |
|---|---|---|---|---|
| Sex | ||||
| Female | 12 (52%) | 8 (35%) | 9 (56%) | 7 (41%) |
| Male | 11 (48%) | 15 (65%) | 7 (44%) | 10 (59%) |
| Age (years), median (IQR) | 51.0 (35–56) | 51.0 (44–59) | 53.5 (47.0–57.5) | 54.0 (45.0–62.0) |
| Pretransplant (Tx) disease | ||||
| Cystic fibrosis | 7 (30%) | 6 (26%) | 2 (13%) | 4 (24%) |
| Emphysema | 11 (48%) | 8 (35%) | 9 (56%) | 6 (35%) |
| Fibrosing alveolitis | 2 (9%) | 4 (17%) | 2 (13%) | 3 (18%) |
| Other* | 3 (13%) | 5 (22%) | 3 (19%) | 4 (24%) |
| Tx procedure | ||||
| Double lung | 14 (61%) | 13 (57%) | 7 (44%) | 9 (53%) |
| Single lung | 9 (39%) | 9 (39%) | 9 (56%) | 7 (41%) |
| Heart lung | 0 | 1 (4%) | 0 | 1 (6%) |
| Years between Tx and BOS | ||||
| Median (IQR) | 3.7 (1.3–7.4) | 2.2 (1.3–5.0)† | 4.2 (2.6–7.8) | 2.0 (1.3–4.0) |
| BOS stage | ||||
| 1 | 13 (57%) | 17 (74%) | 10 (63%) | 13 (77%) |
| 2 | 8 (35%) | 4 (17%) | 6 (38%) | 3 (18%) |
| 3 | 2 (9%) | 2 (9%) | 0 | 1 (6%) |
| FEV1 (litres), median (IQR) | 1.5 (1.2–2.4) | 1.7 (1.5–2.5) | 1.6 (1.2–2.4) | 1.7 (1.5–2.2) |
| FVC (L), median (IQR) | 3.0 (2.3–3.6) | 2.9 (2.2–3.6) | 2.7 (2.1–3.6) | 2.9 (2.1–3.5) |
| TBB A and B scores‡ | ||||
| Missing | 2 (9%) | 4 (17%) | 2 (13%) | 3 (18%) |
| Ax | 5 (22%) | 8 (35%) | 3 (19%) | 7 (41%) |
| A0 | 12 (52%) | 7 (30%) | 7 (44%) | 4 (24%) |
| A1 | 4 (17%) | 3 (13%) | 4 (25%) | 2 (12%) |
| A2 | 0 | 1 (4%) | 0 | 1 (6%) |
| Missing | 2 (9%) | 4 (17%) | 2 (13%) | 3 (18%) |
| Bx | 5 (22%) | 7 (30%) | 5 (31%) | 4 (24%) |
| B0 | 5 (22%) | 6 (26%) | 2 (13%) | 5 (29%) |
| B1R | 9 (39%) | 6 (26%) | 7 (44%) | 5 (29%) |
| B2R | 2 (9%) | 0 | 0 | 0 |
| BAL microbiology | ||||
| Missing | 2 (9%) | 2 (9%) | 2 (13%) | 1 (6%) |
| NPI | 11 (48%) | 14 (61%) | 8 (50%) | 11 (65%) |
| ‘Any’ organism | 10 (43%) | 7 (30%) | 6 (38%) | 5 (29%) |
| ‘Any’ includes: Pa | 5 | 4 | 3 | 3 |
| Asp Fum | 2 | 0 | 1 | 0 |
| Ca | 4 | 2 | 2 | 1 |
| Other | 2 | 1 | 1 | 1 |
*Other Pre Tx disease: Obliterative Bronchiolitis, Sarcoid, Congenital heart disease, Histiocytosis X, Silicosis.
†One patient randomised to the placebo arm >10 years post transplant (at 11.9 years).
‡ISHLT grades (ref 20) BAL Microbiology=Clinical microbiology. Other=Proteus mirabilis, Stenotrophomonas Maltophilia, Ralstonia Picketti, Candida species. Percentages for patients growing individual organisms are not given since some patients grew more than one organism.
Asp Fum, Aspergillus fumigatus; BAL, bronchoalveolar lavage; BOS, bronchiolitis obliterans syndrome; Ca, Candida albicans; NPI, no pathogens identified; Pa, Pseudomanas aeruginosa; TBB, transbronchial biopsy.