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. 2021 Jan 15;2021(1):CD013198. doi: 10.1002/14651858.CD013198.pub2

Banerjee 2005.

Study characteristics
Methods Design: randomised, double‐blind, placebo‐controlled, parallel‐group design.
Duration: 13 weeks
Location: 2 UK hospital clinics
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
Interventions
  • Clarithromycin (long‐acting Klaricid XL 500 mg/d)

  • Placebo


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.
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
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