Change from baseline results of primary and secondary outcomes: intention-to-treat analysis with no imputation
| Outcome | Placebo | Co-trimoxazole | Unadjusted | Adjusted for baseline | ||||
|---|---|---|---|---|---|---|---|---|
| N | Mean (SD/%) | N | Mean (SD/%) | p Value | 95% CI | p Value | 95% CI | |
| FVC (ml) | 60 | −195.67 (288.82) | 63 | −182.22 (330.15) | 0.781 | 15.50 (−93.6 to 124.63) | 0.988 | 0.00 (−0.11 to 0.11) |
| FVC percent predicted (%) | 60 | −4.79 (8.70) | 63 | −4.65 (9.96) | 0.938 | 0·13 (−3·14 to 3·40) | 0.978 | 0.05 (−3.22 to 3.32) |
| TLC (ml) | 45 | −410.00 (1328.39) | 44 | −201.36 (582.69) | 0.127 | 307.98 (−87.42 to 703.38) | 0.943 | 0.01 (−0.30 to 0.32) |
| TLC percent predicted (%) | 45 | −5.70 (19.54) | 44 | −3.58 (9.87) | 0.212 | 3.74 (−2.14 to 9.62) | 0.972 | −0.08 (−4.73 to 4.57) |
| Dlco (mmol/min/kPa) | 50 | −0.22 (0.81) | 45 | −0.30 (0.68) | 0.429 | −0.12 (−0.41 to 0.17) | 0.480 | −0.11 (−0.40 to 0.19) |
| Dlco percent predicted (%) | 50 | −3.88 (10.75) | 45 | −3.67 (8.10) | 0.812 | −0.44 (−4.02 to 3.15) | 0.459 | −1.34 (−4.88 to 2.21) |
| SGRQ symptoms (units) | 53 | 0.76 (15.83) | 53 | −4.82 (16.37) | 0.067 | −5.73 (−11.86 to 0.40) | 0.009 | −6.88 (−12.06 to −1.70) |
| SGRQ activity (units) | 55 | 3.09 (13.27) | 52 | 0.43 (15.10) | 0.339 | −2.64 (−8.05 to 2.77) | 0.484 | −1.82 (−6.91 to 3.27) |
| SGRQ impact (units) | 54 | 0.99 (13.88) | 50 | 2.50 (18.68) | 0.643 | 1.50 (−4.83 to 7.83) | 0.690 | 1.24 (−4.86 to 7.34) |
| SGRQ total (units) | 52 | 1.78 (11.59) | 49 | 0.71 (13.96) | 0.658 | −1.13 (−6.16 to 3.89) | 0.599 | −1.30 (−6.13 to 3.54) |
| 6MWT distance (m) | 31 | −19.48 (86.49) | 20 | −18.70 (75.39) | 0.983 | 0.50 (−45.98 to 46.97) | 0.835 | −5.16 (−53.55 to 43.24) |
| 6MWT desaturation of ≥4% | 31/35 (88.6%) | 16/20 (80.0%) | 0.396 | 0.52 (0.11 to 2.36) | 0.634 | 0.87 (−2.37 to 4.10) | ||
| EQ5D-based utility | 73 | −0.18 (0.31) | 71 | −0.17 (0.35) | 0.801 | 0.01 (−0.09 to 0.12) | 0.920 | 0.10 (0.01 to 0.20) |
| MRC score (units) | 56 | 0.21 (0.82) | 54 | 0.07 (0.72) | 0.319 | −0.15 (−0.43 to 0.14) | 0.533 | 0.09 (−0.37 to 0.19) |
| Hospital days | 59 | 0.81 (1.92) | 54 | 3.06 (12.48) | 0.329 | 0.64* (0.26 to 1.56) | 0.329 | 0.64 (0.26 to 1.56) |
| Death | 19/86 (22.1%) | 18/95 (19.0%) | 0.379 | 0.74* (0.38 to 1.45) | ||||
| Medicine increase | 22/65 (33.9%) | 12/57 (21.1%) | 0.122 | 0.48 (0.19 to 1.21) | ||||
| Medicine decrease | 5/57 (8.8%) | 7/54 (13.0%) | 0.541 | 1.47 (0.43 to 5.04) | ||||
| Oxygen increase | 11/61 (18.0%) | 2/55 (3.6%) | 0.027 | 0.15 (0.03 to 0.80) | ||||
| Oxygen decrease | 0/56 (0.0%) | 0/54 (0.0%) | – | – | ||||
Units are number of patients unless indicated.
*HR.
Dlco, total lung diffusing capacity of carbon monoxide; EQ5D, EuroQol; FVC, forced expiratory volume; ml, millilitres; MRC score, Medical Research Council Dyspnoea Score; 6MWT, 6-minute walking test; SGRQ, St George's Respiratory Questionnaire; TLC, total lung capacity.