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Randomized Controlled Trial Multicenter Study
Inhaled mannitol for non-cystic fibrosis bronchiectasis: a randomised, controlled trial.
- Diana Bilton, Gregory Tino, Alan F Barker, Daniel C Chambers, Anthony De Soyza, Lieven J A Dupont, Conor O'Dochartaigh, Eric H J van Haren, Luis Otero Vidal, Tobias Welte, Howard G Fox, Jian Wu, Brett Charlton, and B-305 Study Investigators.
- Department of Respiratory Medicine, Royal Brompton Hospital, London, UK.
- Thorax. 2014 Dec 1;69(12):1073-9.
RationaleBronchiectasis is characterised by excessive production of mucus and pulmonary exacerbations. Inhaled osmotic agents may enhance mucociliary clearance, but few long-term clinical trials have been conducted.ObjectivesTo determine the impact of inhaled mannitol on exacerbation rates in patients with non-cystic fibrosis (CF) bronchiectasis. Secondary endpoints included time to first exacerbation, duration of exacerbations, antibiotic use for exacerbations and quality of life (QOL) (St George's Respiratory Questionnaire, SGRQ).MethodsPatients with non-CF bronchiectasis and a history of chronic excess production of sputum and ≥2 pulmonary exacerbations in the previous 12 months were randomised (1:1) to 52 weeks treatment with inhaled mannitol 400 mg or low-dose mannitol control twice a day. Patients were 18-85 years of age, baseline FEV1 ≥40% and ≤85% predicted and a baseline SGRQ score ≥30.Main Results461 patients (233 in the mannitol and 228 in the control arm) were treated. Baseline demographics were similar in the two arms. The exacerbation rate was not significantly reduced on mannitol (rate ratio 0.92, p=0.31). However, time to first exacerbation was increased on mannitol (HR 0.78, p=0.022). SGRQ score was improved on mannitol compared with low-dose mannitol control (-2.4 units, p=0.046). Adverse events were similar between groups.ConclusionsMannitol 400 mg inhaled twice daily for 12 months in patients with clinically significant bronchiectasis did not significantly reduce exacerbation rates. There were statistically significant improvements in time to first exacerbation and QOL. Mannitol therapy was safe and well tolerated.Trial Registration NumberNCT00669331.Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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