Wang 2017.
Study characteristics | ||
Methods |
Design: randomised, controlled, parallel‐group trial Duration: 26 weeks Location: Zhengzhou Hospital, China |
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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 |
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Interventions |
Allowed co‐medications: cough relief medication, aminophylline, beta2 receptor agonist |
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Outcomes | Blood gas analysis, FEV₁, FVC, 6MWT, pulmonary arterial pressure | |
Notes |
Funding: "Grant Support & Financial Disclosures: None" Identifier: not reported |
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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; FEV₁: 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.