Clinical responses of primary and secondary outcome parameters compared with baseline data for 86 patients by intent-to-treat analysis
| Fluticasone group (n = 43, 23F) | Placebo group (n = 43, 34F) | |||||
|---|---|---|---|---|---|---|
| Clinical response after treatment | Clinical response after treatment | |||||
| Improvement n (%) | Deterioration n (%) | No change n (%) | Improvement n (%) | Deterioration n (%) | No change n (%) | |
| *p<0.05 when both treatment groups compared for the number of patients who showed improvement or otherwise (deterioration or no change) using χ2 or Fisher’s exact tests. | ||||||
| Primary outcome parameters | ||||||
| 24 hour sputum volume (ml)* | 28 (65.1) | 5 (11.6) | 10 (23.3) | 18 (41.9) | 10 (23.2) | 15 (34.9) |
| Exacerbation frequency(/year) | 22 (51.2) | 7 (16.2) | 14 (32.6) | 16 (37.2) | 11 (25.6) | 16 (37.2) |
| Secondary outcome parameters | ||||||
| Sputum purulence score | 13 (30.2) | 10 (23.3) | 20 (46.5) | 9 (20.9) | 15 (34.9) | 19 (44.2) |
| FEV1 % predicted | 2 (4.7) | 4 (9.3) | 37 (86.0) | 3 (7.0) | 3 (7.0) | 37 (86.0) |
| FVC % predicted | 4 (9.3) | 3 (7.0) | 36 (83.7) | 4 (9.3) | 1 (2.3) | 38 (88.4) |