Banerjee 2005.
Study characteristics | ||
Methods |
Design: randomised, double‐blind, placebo‐controlled, parallel‐group design. Duration: 13 weeks Location: 2 UK hospital clinics |
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Participants |
Population: 67 adults with COPD were randomly assigned to clarithromycin (n = 31) or placebo (n = 36) Baseline characteristics: mean age 65.1 (clarithromycin) vs 68.1 years (placebo); mean FEV₁ 1.12 L (clarithromycin) vs 1.13 L (placebo); severity of COPD moderate or worse according to BTS guidelines. All patients were taking ICS; exacerbation history was not reported Inclusion criteria: patients enrolled from hospital clinics; no acute exacerbations of COPD over the past 6 weeks Exclusion criteria: previous documented allergies to macrolides; clinical history of lung cancer, asthma, or bronchiectasis |
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Interventions |
Allowed co‐medications: participants were allowed to take their medication as prescribed by their primary care doctor. All participants were taking ICS, LABA (18%), inhaled anticholinergics (63%). Equal numbers of participants in each treatment arm were taking both LABA and anticholinergics. |
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Outcomes | Health‐related quality of life, infective exacerbation rate, shuttle walk test, serum C‐reactive protein level, sputum bacterial quantities load | |
Notes |
Funding: Abbott Pharmaceuticals Identifier: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block randomisation was carried out |
Allocation concealment (selection bias) | Low risk | Patient randomisation was not known to trial staff. Randomisation was carried out by the Birmingham Hospital Pharmacy Department |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind study |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Trial staff were unaware of randomisation, but blinding of outcome assessors was not clearly described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcome data were described |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes were reported |
Other bias | Low risk | No other bias was identified |