Bachh 2007.
Methods | Randomised, single‐blind, placebo‐controlled, parallel, single‐centre. Follow‐up 12 months, although treatment given for only 4 months | |
Participants | 100 outpatients with smoking‐related COPD. Age > 50 years; post‐bronchodilator FEV₁ 30% to 80% predicted; reversibility < 12%; FEV₁/FVC < 70%. Stable medications and ICS permitted at steady dose
Exclusions: intolerance of NAC, continuous treatment with OCS, NAC for 3/12 or more, asthma or atopy, other respiratory diseases, NYHA Class II or greater heart failure. Non‐compliance in taking medication Mean age: 61 (SD 7) years; 78% male. Mean duration of disease 6.4 years. Mean number of exacerbations in 2 years before study, 4.7. Mean FEV₁ 52% (SD 10) predicted and reversibility 6% (SD3). 18/100 (18%) were using ICS No dropouts recorded |
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Interventions | NAC 600 mg once daily or placebo for 4 months | |
Outcomes | Exacerbations, hospital admissions, pulmonary function tests, adverse effects | |
Notes | Indian study | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Information not available |
Allocation concealment (selection bias) | High risk | Single‐blind |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Single‐blind; investigators not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Single‐blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts recorded |
Selective reporting (reporting bias) | Low risk | Main outcomes reported |