Fluticasone and N-acetylcysteine in primary care patients with COPD or chronic bronchitis

SummaryBackgroundIncreased oxidative stress and bronchial inflammation are important mechanisms in the pathophysiology of COPD.AimTo investigate whether treatment with the inhaled corticosteroid fluticasone propionate (FP) or the anti-oxidative agent N-acetylcysteine (NAC) are effective in primary care patients.MethodsThe study was a 3-year placebo-controlled randomised controlled trial preceded by a 3-month washout and 2-week prednisolone pre-treatment. Patients were (ex-)smokers with chronic bronchitis or COPD. Interventions were inhaled FP 500 μg b.i.d., oral NAC 600 mg o.d., or placebo. Exacerbation rate and quality of life measured with the Chronic Respiratory Questionnaire (CRQ) were the primary outcomes, FEV1 decline and respiratory symptoms secondary outcomes.Results286 patients recruited from 44 general practices were randomised. Exacerbation rate was 1.35 times higher for NAC (p = 0.054) and 1.30 times higher for FP (p = 0.095) compared with placebo. CRQ total scores did not differ between NAC (p = 0.306) or FP (p = 0.581) treatment compared to placebo. Annual postbronchodilator FEV1 decline was 64 mL [SD 5.4] for NAC [p = 0.569 versus placebo], 59 mL [SD 5.7] for FP [p = 0.935], and 60 mL [SD 5.4] for placebo.ConclusionNo beneficial treatment effects for either high-dosed inhaled fluticasone propionate or oral N-acetylcysteine were observed in our study population of patients with COPD or chronic bronchitis.