| Methods |
Type: Parallel group. Duration: 6 weeks. Pre‐randomisation run‐in period: 1 week. Randomisation method: Not stated. Blinding: Double‐blind. Co‐interventions allowed: Inhaled corticosteroid, oral corticosteroid (doses fixed throughout study period), short‐acting B‐agonist PRN. Co‐interventions NOT allowed: ipratropium, long‐acting B‐agonist, oral B‐agonist, theophylline. Confounders: None noted. Assessment score: 3 |
| Participants |
Setting: Outpatients in UK+Netherlands, referral population. Inclusion criteria: Prior diagnosis of COPD (ATS), FEV1 25‐65% predicted, ratio <=70%, age >40 years, smoking history > 10 pack years. Exclusion criteria: asthma, allergic rhinitis, atopy, total eosinophil count >= 600/mm³, COPD exacerbation in prior 4 weeks, significant disease other than COPD. Number recruited: 121 Mean age: 66 years Gender: 75% male Baseline FEV1: 1.1 +/‐ 0.4 L; FVC 2.2 +/‐ 0.7 L; Ratio 41 +/‐ 12 %. Baseline co‐interventions allowed during trial: short‐acting B‐agonist 85%; inhaled corticosteroid 78%; oral corticosteroid 2%. Baseline co‐interventions NOT allowed during trial: ipratropium 39%; long‐acting B‐agonist ‐‐ not reported; oral B‐agonist 9%; theophylline 4%. |
| Interventions |
Experimental1: tiotropium 18 ug qAM by handihaler. Experimental2: tiotropium 18 ug qPM by handihaler. Control: Placebo. |
| Outcomes |
Analysed: Cumulative incidence of exacerbations, hospitalisations; change in FEV1 and FVC for groups. |
| Notes |
The original report showed no difference in clinical outcomes between intervention groups receiving morning and evening tiotropium; these groups were therefore combined for analyses of clinical outcomes. For analyses of spirometric indices, data were included for morning tiotropium and placebo groups only. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
