Table 1. Baseline Characteristics of Participants in a Study of the Effect of Co-trimoxazole vs Placebo on Death, Lung Transplant, or Hospital Admission in Patients With Idiopathic Pulmonary Fibrosis.
| Characteristic | Co-trimoxazole (n = 169a) | Placebo (n = 172a) |
|---|---|---|
| Sex, No. (%) | ||
| Men | 138 (81.7) | 157 (91.3) |
| Women | 31 (18.3) | 15 (8.7) |
| Age, mean (SD), y | 71.9 (7.8) | 70.7 (7.1) |
| Smoking status, No. (%) | ||
| Never | 59 (34.9) | 56 (32.6) |
| Ex-smoker | 109 (64.5) | 114 (66.3) |
| Current | 1 (0.6) | 2 (1.2) |
| Comorbidities, No. (%)b | ||
| Gastroesophageal reflux disease | 69 (40.8) | 62 (36.1) |
| Ischemic heart disease or angina | 38 (22.5) | 44 (25.6) |
| Diabetes | 40 (23.7) | 25 (14.5) |
| Anxiety or depression | 17 (10) | 23 (13.4) |
| Pulmonary hypertension | 13 (7.7) | 10 (5.8) |
| Osteoporosis | 11 (6.5) | 11 (6.4) |
| Chronic obstructive pulmonary disease | 6 (3.6) | 6 (3.5) |
| Bronchiectasis | 2 (1.2) | 7 (4.1) |
| Maintenance treatments, No. (%) | ||
| Proton pump inhibitor | 87 (51.5) | 78 (45.3) |
| Pirfenidone | 71 (42.0) | 66 (38.4) |
| Nintedanib | 56 (33.1) | 61 (35.5) |
| Prednisolone | 12 (7.1) | 10 (5.8) |
| N-acetylcysteine | 8 (4.7) | 7 (4.1) |
| Other antioxidant | 3 (1.8) | 5 (2.9) |
| Lung function, mean (SD)c | ||
| Absolute value | ||
| FVC, L | 2.2 (0.6) | 2.3 (0.5) |
| FEV1, L | 1.9 (0.5) | 1.9 (0.4) [n = 171] |
| FEV1/FVC ratio | 0.8 (0.1) | 0.8 (0.1) [n = 171] |
| DLCO, mmoL/min/kPa | 3.6 (1.8) [n = 123] | 3.7 (1.5) [n = 127] |
| Predicted value, % | ||
| FVC | 56.2 (8.9) | 55.2 (10.0) |
| FEV1 | 61.5 (9.3) | 60.0 (10.6) [n = 171] |
| DLCO | 43.3 (20.2) [n = 123] | 44.5 (18.0) [n = 127] |
| Outcome measures, mean (SD) | ||
| Medical Research Council dyspnea score, median (IQR)d | 3.0 (2.0-3.0) [n = 167] | 2.00 (2.00-3.00) [n = 171] |
| EQ-5D-5L utility scoree | 0.67 (0.20) [n = 168] | 0.69 (0.22) [n = 171] |
| Cough severity scoref | 39.5 (27.5) [n = 167] | 40.9 (26.6) [n = 168] |
| Leicester Cough Questionnaire scoresg | ||
| Total | 16.1 (3.6) [n = 161] | 15.8 (3.7) [n = 164] |
| Physical | 5.2 (1.1) [n = 161] | 5.1 (1.0) [n = 165] |
| Psychological | 5.4 (1.4) [n = 167] | 5.3 (1.5) [n = 166] |
| Social | 5.4 (1.4) [n = 167] | 5.4 (1.4) [n = 168] |
| King’s Brief Interstitial Lung Disease questionnaire scoresh | (n = 168) | (n = 171) |
| Total | 53.7 (9.7) | 53.6 (10.6) |
| Breathlessness | 37.7 (15.3) | 38.9 (14.3) |
| Chest | 62.9 (20.8) | 62.6 (20.7) |
| Psychological | 55.2 (14.9) | 54.9 (17.1) |
Abbreviations: DLCO, diffusing capacity for carbon monoxide; FEV1, forced expiratory volume in the first second of expiration; FVC, forced vital capacity; IQR, interquartile range.
These data exclude the individual who was excluded after randomization.
Comorbidities were as detailed in the medical records.
The lung function test values were obtained at screening.
Medical Research Council dyspnea score is a 5-point scale ranging from 1 to 5 (higher values represent increasing breathlessness); a value of 3 represents walking slower than contemporaries or having to stop when walking at own pace.
The 5-level Euroqol 5-dimension questionnaire (EQ-5D-5L) utility score ranges from −0.59 to 1 (higher score indicates better health utility); a value of 0.75 indicates that the quality of life–adjusted years has been reduced by a slight amount. Utilities are calculated by mapping to standard health state valuations.
The cough severity score is a cough severity visual analog scale ranging from 0 to 100 (higher scores represent greater cough severity); a value of 40 indicates that coughing is two-fifths of the maximum perceived cough severity.
The Leicester Cough Questionnaire is a cough-related quality of life score that ranges from 3 to 21 (domain scores range from 1-7; higher values represent better quality of life); a value of 15 suggests a cough that has affected life activities a small amount of the time over the past 2 weeks. It is calculated as the sum of the individual domains.
The King’s Brief Interstitial Lung Disease questionnaire total and domain scores range from 0 to 100 (higher values indicate better health status); a value of 50 indicates that idiopathic pulmonary fibrosis has affected life activities some of the time over the past 2 weeks. It is calculated using the logit-scoring method.