Tan 2016.
Study characteristics | ||
Methods |
Design: randomised, placebo‐controlled, parallel‐group design Duration: 52 weeks Location: outpatient department at a medical university hospital |
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Participants |
Population: 49 adults with COPD (GOLD stages 2 to 4) were randomly assigned to erythromycin (n = 36) or control (n = 18) Baseline characteristics: age (mean years): 68.4 (SD 6.6); % male: 89; % FEV₁ predicted (mean): 44.4 (SD 13.8); pack‐years (mean): 41.3 (SD 25.8); exacerbation history: not reported Inclusion criteria: stable COPD diagnosis according to GOLD guidelines, FEV₁ < 80% predicted, FEV₁‐to‐FVC < 70%; no acute exacerbation, no change in therapeutic treatment, no antibiotic treatment in the last 4 weeks Exclusion criteria: bronchial asthma; primary bronchiectasis; diffuse pan bronchiolitis; active tuberculosis; lung cancer; pneumoconiosis; other lung disease with restrictive ventilatory impairment; cardiovascular, nervous system, or endocrine disease; blood, hepatic, or kidney disease; malignant tumour, inability to communicate, serious adverse reaction to erythromycin |
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Interventions |
Allowed co‐medications: supplemental oxygen, theophylline, inhaled bronchodilators and corticosteroids. Other macrolides, histamine antagonists, non‐steroidal anti‐inflammatory drugs, and oral glucocorticosteroids were not allowed |
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Outcomes | Concentrations of IL‐17 and IL‐23 in peripheral blood and induced sputum, 6‐minute walk distance, serious adverse events | |
Notes |
Funding: National Nature Science Foundation of China (81460009) and Guangxi Natural Science Foundation Identifier: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomly divided"; no other details were provided |
Allocation concealment (selection bias) | Unclear risk | No further information was provided |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of participants or personnel was described. Study was assumed to be open‐label (although abstract states double‐blind). Study authors have been contacted; we await clarification response |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of outcome assessors was described. Study was assumed to be open‐label (although abstract states double‐blind). Study authors have been contacted; we await clarification response |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Dropout was low and balanced, but details of how many people were analysed at each time point were not given |
Selective reporting (reporting bias) | Unclear risk | No prospective trial registration or protocol was identified, so it is not clear if outcomes of interest for this review may have been collected but not reported (e.g. serious adverse events, exacerbations, quality of life) |
Other bias | Low risk | No other bias was identified |