Jung 2012.
| Methods | Design: a randomised, open‐label, multi‐centre, 2‐arm, parallel study from April 2009 to March 2010. The trial was conducted at 30 academic hospital‐based pulmonary clinics in Korea | |
| Participants |
Population: 479 participants with COPD Baseline characteristics: mean age 67 years. Moderate to very severe COPD with mean FEV1 predicted of 50.8%. 98% men Inclusion criteria: participants diagnosed with COPD who had a post‐bronchodilator FEV1/FVC ratio < 0.70 and FEV1 < 65% of predicted value in the past 1 year or at screening. Eligible participants were 40 to 80 years of age and had a smoking history of 10 or more pack‐years Exclusion criteria: a history of physician‐diagnosed asthma or a chronic respiratory disorder other than COPD that was clinically significant; any uncontrollable or serious disease that might affect participation in the study; use of systemic corticosteroids or immunosuppressants within 4 weeks before study entry; any malignant disease; a history of severe glaucoma, urinary tract obstruction or previous lung volume reduction surgery; women who were pregnant or lactating; known hypersensitivity or intolerance to tiotropium or FSC |
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| Interventions | • Tiotropium (Spiriva HandiHaler (Boehringer Ingelheim Pharma, Ingelheim, Germany)), 18 mcg once daily • Tiotropium 18 mcg once daily + FSC (Seretide Diskus (GlaxoSmithKline, Brentford, UK)), 250/50 mcg/puff, 1 puff twice daily |
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| Outcomes |
Primary: change in pre‐bronchodilator FEV1 (L) from baseline to week 24 Secondary: mean changes in pre‐bronchodilator FEV1 (L) from baseline to weeks 4, 8 and 16; mean changes in pre‐bronchodilator inspiratory capacity (IC); FVC and percent predicted (% pred) values for FEV1; mean changes in HRQoL; frequency of COPD exacerbations; exacerbations requiring hospitalisations, emergency room visits or outpatient clinic visits; hospitalisation rates for all causes |
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| Notes |
Co‐medication: All participants were provided with a salbutamol inhalation aerosol and were instructed to use it when necessary to relieve symptoms. Before the run‐in period, participants stopped their usage of ICA and long‐acting bronchodilators, but therapy with other regular medications such as oxygen, mucolytics and methylxanthines was allowed throughout the study for all participants This study was supported by a grant from the Korea Healthcare Technology R&D Project, Ministry for Health and Welfare, Republic of Korea (A102065), and from GlaxoSmithKline Korea |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was done in a 1:1 ratio through a computerised random‐number generator |
| Allocation concealment (selection bias) | Low risk | Neither research staff nor participants were aware of treatment assignment until randomised |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | No details |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Drop‐out rates were 14% in the tiotropium + placebo group and 13% in the tiotropium + LABA/ICS comb group |
| Selective reporting (reporting bias) | Low risk | Results were reported for all listed primary and secondary outcomes |