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

Wang 2017.

Study characteristics
Methods Design: randomised, controlled, parallel‐group trial
Duration: 26 weeks
Location: Zhengzhou Hospital, China
Participants Population: 86 adults with moderate to severe COPD were randomly assigned to azithromycin (n = 43) or placebo (n = 43)
Baseline characteristics: age (mean years): 71.4 (SD 8.2), % male (mean): 59, FEV₁ (mean): 0.67 L (SD 0.095); exacerbation history: not reported
Inclusion criteria: 45 years of age with history of severe COPD diagnosed with pulmonary function test and tracheostomy
Exclusion criteria: allergy to macrolides, life expectancy < 1 year
Interventions
  • Azithromycin 250 mg once daily plus simvastatin 20 mg once daily

  • Placebo: simvastatin 20 mg once daily


Allowed co‐medications: cough relief medication, aminophylline, beta2 receptor agonist
Outcomes Blood gas analysis, FEV₁, FVC, 6MWT, pulmonary arterial pressure
Notes Funding: "Grant Support & Financial Disclosures: None"
Identifier: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "randomly divided into an observation group and a control group using random number table, 43 in each group"
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
Blinding of outcome assessment (detection bias)
All outcomes High risk No blinding of outcome assessors was described. Study was assumed to be open‐label
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No further information was provided
Selective reporting (reporting bias) High risk No prospective trial registration or protocol was identified. Dyspnoea grade was reported as measured in the abstract but was not described in the methods. It is not clear if FEV₁ and FVC variance are SDs or SEs
Other bias Low risk No other bias was identified

Abbreviations

6MWT: six‐minute walk test; AE: adverse event; AECOPD: acute exacerbation of chronic obstructive pulmonary disease; bpm: beats per minute; BTS: British Thoracic Society; CAT: COPD assessment test; COPD: chronic obstructive pulmonary disease; ED: emergency department; FEV: forced expiratory volume in one second; FVC: forced vital capacity; GOLD: Global Initiative for Chronic Obstructive Lung Disease; HRQoL: health‐related quality of life; ICS: inhaled corticosteroid; ITT: intention‐to‐treat; LABA: long‐acting beta‐agonist; LAMA: long‐acting muscarinic antagonist; LCQ: Leicester Cough Questionnaire; NR: not reported; OCS: oral corticosteroids; QT: uncorrected QT interval (measurement of electrical properties of the heart); QTc: corrected QT interval; SABA: short‐acting beta‐agonist; SAE: serious adverse event; SAMA: short‐acting muscarinic antagonist; SD: standard deviation; SE: standard error; SF36: short form 36; SGRQ: St George's Respiratory Questionnaire; ULN: upper limit of normal.