Patient characteristics
| Fluticasone±salmeterol for 30 months | Placebo for 30 months | Fluticasone for 6 months followed by placebo between 6 and 30 months | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 6 months | 30 months | Baseline | 6 months | 30 months | Baseline | 6 months | 30 months | |
| Number of included patients | 45 | 23 | 21 | ||||||
| Number of biopsies available at each time point | 37 | 39 | 31 | 21 | 17 | 17 | 21 | 21 | 17 |
| Male/female, n | 41/4 | 19/4 | 19/3 | ||||||
| Age, years | 62.4±7.2 | 60.2±7.8 | 63.1±7.4 | ||||||
| BMI | 25.5±3.7 | 24.2±3.9 | 25.4±3.6 | ||||||
| Current smokers, n (%) | 22 (59) | 20 (51) | 14 (45) | 14 (67) | 10 (59) | 8 (47) | 10 (48) | 9 (43) | 8 (47) |
| RIN score | 3.3±1.5 | 3.5±1.3 | 4.8±1.5** | 3.5±1.3 | 3.9±1.6 | 5.2±1.8** | 3.3±1.7 | 3.7±1.7 | 3.7±1.5 |
| FEV1, % predicted | 62.6±9.0 | 63.6±10.7 | 64.2±12.3 | 61.3±8.80 | 62.3±9.20 | 57.0±8.3 | 64.7±8.62 | 64.9±9.0 | 64.2±12.5 |
| Reversibility, % predicted FEV1 | 6.9±5.3 | 7.1±4.8 | 7.3±5.4 | ||||||
| PC20 methacholine, (mg/mL)‡ | 0.43 (0.01–14.45) | 0.95 (0.04–8.53) | 0.45 (0.04–76.80) | ||||||
| RV, % predicted | 147.1±37.3 | 140.5±29.3 | 135.1±34.5 | 146.0±25.9 | 144.9±31.0 | 139.3±20.9 | 145.2±36.4 | 137.0±34.5 | 134.2±34.6 |
| RV/TLC, % predicted | 123.2±19.0 | 119.9±18.6 | 116.3±25.0 | 125.2±16.9 | 123.6±16.8 | 120.4±14.0 | 124.7±19.1 | 120.6±19.5 | 118.6±21.1 |
| TLCO, % predicted | 65.9±20.0 | 68.7±19.9 | 63.5±19.8 | 58.6±18.0 | 59.8±16.0 | 59.4±14.0 | 68.9±24.5 | 69.2±25.3 | 71.0±25.3 |
| SGRQ | 29.4±12.4 | 28.7±15.5 | 26.8±14.6 | 30.6±18.6 | 32.8±21.0 | 33.4±20.1 | 27.6±15.6 | 26.8±15.0 | 22.12±15.2 |
| Bronchial biopsies, n/0.1 mm2 | |||||||||
| Macrophages† | 1.08±0.32 | 0.70±0.34** | 0.73±0.58** | 0.98±0.40 | 0.76±0.36 | 0.87±0.42 | 0.96±0.22 | 0.74±0.35* | 0.86±0.52 |
| Neutrophils† | 0.75±0.32 | 0.93±0.37* | 1.1±0.46** | 0.76±0.37 | 0.77±0.39 | 0.89±0.42 | 0.77±0.33 | 0.80±0.35 | 1.13±0.52* |
| Eosinophils† | 0.49±0.43 | 0.26±0.35* | 0.64±0.60 | 0.53±0.53 | 0.33±0.42 | 0.47±0.48 | 0.68±0.53 | 0.22±0.36** | 0.86±0.72 |
| CD4 cells† | 1.82±0.30 | 1.08±0.32** | 1.30±0.39** | 1.65±0.39 | 1.52±0.35 | 1.40±0.40 | 1.60±0.27 | 1.22±0.46** | 1.47±0.42 |
| CD8 cells† | 1.44±0.39 | 0.87±0.32** | 0.90±0.39** | 1.31±0.38 | 1.14±0.26 | 1.28±0.29 | 1.10±0.42 | 0.88±0.37 | 1.03±0.51 |
| Mast cells† | 1.42±0.23 | 0.77±0.33** | 0.61±0.41** | 1.41±0.17 | 1.02±0.18** | 1.15±0.18** | 1.49±0.21 | 0.79±0.30** | 1.03±0.25** |
| Intact epithelium, %† | 1.37±0.34 | 1.34±0.25 | 1.27±0.30 | 1.34±0.39 | 1.24±0.26 | 0.89±0.52** | 1.34±0.44 | 1.26±0.29 | 1.14±0.42 |
Data are presented as mean± SD unless stated otherwise. Differences in variables before and after treatment were analysed using a two-sided, paired, Student's t test.
*p<0.05 versus baseline, **p<0.01 versus baseline.
†Log transformed.
‡Geometric mean with range between brackets.
BMI, body mass index; FEV1, forced expiratory volume in one second; PC20, provocative concentration [or dose] causing a 20% fall in FEV1; RIN, RNA integrity number; RV, residual volume; SGRQ, Saint George Respiratory Questionnaire; TLC, total lung capacity; TLCO, transfer factor of the lung for carbon monoxide.