Blasi 2010.
Study characteristics | ||
Methods |
Design: randomised, uncontrolled, open‐label, parallel‐group design Duration: 26 weeks Location: 5 centres across Italy |
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Participants |
Population: 22 adults with severe COPD were randomly assigned to azithromycin (n = 11) or standard care (n = 11) Baseline characteristics: age (mean years): 72.5 (SD 7); % male (mean): 86; pack‐years (mean): 36 (SD 19.5); no current smokers, nearly all participants were former smokers (100% in the azithromycin group; 91% in the standard care group); exacerbation history: participants in each treatment arm had a mean of 3 exacerbations in the previous 12 months Inclusion criteria: 45 years of age with a history of severe COPD diagnosed with pulmonary function test and tracheostomy Exclusion criteria: allergy to macrolides; life expectancy < 1 year |
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Interventions |
Allowed co‐medications: not stated |
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Outcomes | Reduction in number of exacerbations, time to first exacerbation, reductions in number of hospitalisations, time to first hospitalisation, quality of life, SAEs, AEs | |
Notes |
Funding: Pfizer, University of Milan Identifier: NCT00323986 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was achieved using a computer‐generated block sequence |
Allocation concealment (selection bias) | Unclear risk | No further information was provided about methods to conceal allocation |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The study was open‐label, and participants and personnel would have been unblinded to treatment allocation |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The study was open‐label, and outcome assessors would not have been blinded to treatment allocation |
Incomplete outcome data (attrition bias) All outcomes | High risk | This was not an ITT analysis, so the analysis did not include participants who died. This may have led to overestimation of outcomes. More deaths occurred in the SC group than in the AZI group, but whether or not deaths were treatment related was not reported |
Selective reporting (reporting bias) | High risk | Outcomes reported in the publication are reported differently from those in the protocol at clinicaltrials.gov. Mortality, AEs, and SAEs are additional outcomes that were not reported at the website. Data for SAEs are reported only for the AZI group. It is not clear whether or not people in the SC group had any SAEs |
Other bias | Low risk | No other bias was identified |