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

Blasi 2010.

Study characteristics
Methods Design: randomised, uncontrolled, open‐label, parallel‐group design
Duration: 26 weeks
Location: 5 centres across Italy
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
Interventions
  • Azithromycin (500 mg daily 3 times a week) plus standard care

  • Standard care (not stated)


Allowed co‐medications: not stated
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
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