Table 1.
Baseline demographic and clinical characteristics of enrolled patients
| AKL1 (N=20)
|
Placebo (N=13)
|
|||
|---|---|---|---|---|
| n | Mean (SD) or n (%) | n | Mean (SD) or n (%) | |
| Age (years) | 20 | 66.9 (11.1) | 13 | 67.3 (6.5) |
| Male sex n (%) | 20 | 12 (60) | 13 | 7 (54) |
| Body mass index (kg/m2) | 20 | 27.0 (4.3) | 13 | 30.0 (6.6) |
| Smoking status n (%) | 20 | 13 | ||
| Current smoker | 10 (50) | 5 (39) | ||
| Ex-smoker | 9 (45) | 7 (54) | ||
| Nonsmoker | 1 (5) | 1 (8) | ||
| Baseline spirometry, post-bronchodilatora | ||||
| FEV1 (L) | 18 | 1.5 (0.7) | 12 | 1.6 (0.6) |
| FEV1 (%predicted) | 19 | 57.9 (17.2) | 12 | 57.3 (16.3) |
| 6-minute walk distance (m) | 20 | 294 (181) | 13 | 347 (145) |
| Leicester Cough Questionnaire score | 19 | 12.1 (3.0) | 13 | 14.6 (2.5) |
| SGRQ total score, units | 17 | 62.5 (14.7) | 11 | 54.3 (16.2) |
| SGRQ – symptoms domain | 75.7 (16.1) | 65.0 (17.7) | ||
| SGRQ – activity domain | 79.9 (17.1) | 68.9 (21.6) | ||
| SGRQ – impact domain | 48.8 (16.5) | 42.4 (16.1) | ||
| Clinical COPD Questionnaire score | 20 | 3.3 (1.0) | 13 | 2.9 (1.1) |
| Modified MRC dyspnea score | 20 | 3.0 (0.6) | 12 | 3.2 (0.4) |
| Medications at baseline n (%) | 20 | 13 | ||
| SABA only | 1 (5) | 1 (8) | ||
| ICS only | 1 (5) | 2 (15) | ||
| LABA only | 1 (5) | 0 | ||
| LAMA only | 3 (15) | 2 (15) | ||
| ICS + LABA | 6 (30) | 3 (23) | ||
| ICS + LABA + LAMA | 6 (30) | 2 (15) | ||
| Missing | 2 (10) | 3 (23) | ||
Notes: Values expressed as means (SD) unless otherwise noted.
a
All patients had an FEV1/FVC ratio of <0.7 at visit 2 (baseline).
Abbreviations: FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; ICS, inhaled corticosteroid; LABA, long-acting β-agonist; LAMA, long-acting muscarinic antagonist; MRC, Medical Research Council; SABA, short-acting β-agonist; SD, standard deviation; SGRQ, St George’s Respiratory Questionnaire.