Mygind 2010.
Study characteristics | ||
Methods |
Design: randomised, placebo‐controlled, double‐blind study Duration: 156 weeks Location: NR |
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Participants |
Population: 575 adults with moderate to severe COPD were randomly assigned to azithromycin (n = 287) or placebo (n = 288) Baseline characteristics: age > 50 years; moderate to severe COPD; % FEV₁ predicted < 60; previous documented allergies to macrolides; clinical history of lung cancer, asthma, or bronchiectasis; exacerbation history: not reported Inclusion criteria: ≥ 1 admission to hospital with an exacerbation of COPD; ex‐smoker or current smoker Exclusion criteria: end‐stage COPD patients (if not expected to survive over 3 years) or bedridden patients; history of asthma, bronchiectasis, or other significant respiratory disease; history of azithromycin allergy; heart, liver, or renal insufficiency; already receiving prophylactic antibiotic |
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Interventions |
Allowed co‐medications: not reported |
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Outcomes | Rate of decline in lung function (FEV₁), frequency of exacerbation, health‐related quality of life, adverse events, mortality, duration of exacerbations, number of days of hospitalisation, frequency of hospitalisation | |
Notes |
Funding: not reported Identifier: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised but paucity of data was available on sequence generation |
Allocation concealment (selection bias) | Unclear risk | This was not explained well |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | This was a double‐blind study |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unknown. This study was double‐blind, but it is unclear whether outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | All outcome data were presented. Only 55% completed 3 years |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes were reported |
Other bias | Unclear risk | This was a conference presentation ‐ not a full publication. Attempts to contact study authors were not successful. Only limited data are available for evaluation of the risk of bias |