Table 2.
Demographic And Baseline Characteristics Of Patients (ITT population)
| Moderate COPDa (N=254) | Severe COPDb (N=191) | All RESTORE Patientsc (N=445) | ||||
|---|---|---|---|---|---|---|
| Erdosteine | Placebo | Erdosteine | Placebo | Erdosteine | Placebo | |
| Patients, n | 126 | 128 | 89 | 102 | 215 | 230 |
| Age, years | 64.8 (7.6) | 66.1 (7.3) | 62.9 (8.9) | 63.1 (8.8) | 63.8 (8.3) | 64.1 (8.2) |
| Male, % | 65.9 | 72.7 | 74.5 | 73.9 | 71.8 | 74.6 |
| BMI, kg/m2 | 27.6 (5.0) | 28.2 (5.6) | 27.0 (4.8) | 27.8 (5.1) | 27.2 (5.3) | 28.0 (5.4) |
| Smoking status, % | ||||||
| Current smoker | 31.7 | 28.9 | 25.8 | 27.5 | 27.1 | 28.0 |
| Ex-smoker | 68.3 | 71.1 | 74.2 | 72.5 | 72.9 | 72.0 |
| ICS,d n (%) | 88 (69.8) | 91 (71.1) | 80 (89.9)* | 94 (92.2)* | 165 (75.8) | 173 (75.2) |
| FEV1, L | 1.61 (0.35) | 1.68 (0.42) | 1.26 (0.39) | 1.23 (0.43) | 1.43 (0.40) | 1.46 (0.47) |
| FEV1, % predicted | 59.88 (6.3) | 61.08 (6.8) | 47.21 (10.83) | 46.72 (11.69) | 51.45 (12.82) | 54.38 (13.33) |
| FVC, L | 2.82 (0.66) | 2.89 (0.72) | 2.59 (0.99)* | 2.54 (0.97)* | 2.74 (0.93) | 2.74 (0.94) |
| Post-BD FEV1/FVC, ratio % | 58.76 (8.8) | 58.00 (8.1) | 51.92 (9.88)* | 50.81 (10.03)* | 54.01 (11.3) | 53.26 (10.8) |
Notes: Data are presented as mean (standard deviation) unless indicated otherwise. aModerate COPD group determined post hoc based on GOLD 2011 spirometry criteria (FEV1 50‒79% predicted); bSevere COPD group determined post hoc based on GOLD 2011 spirometry criteria (FEV1 30%‒49% predicted); cData from Dal Negro et al;23dICS alone or combined with adrenergic agents. *P<0.05 versus moderate COPD group. (Categorical variables have been compared as continuous depending on the distribution: if normal with t-tested for independent samples, if not normal with comparisons between treatment groups used the Mann–Whitney U-test). All comparisons between the erdosteine and placebo groups were non-significant.
Abbreviations: BD, bronchodilator; BMI, body mass index; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; ICS, inhaled corticosteroid; ITT, intention-to-treat; NS, not significant for comparison between treatment groups.