RT Journal Article
SR Electronic
T1 Inhaled mannitol for non-cystic fibrosis bronchiectasis: Results of a 12 month, multi-centre, double-blind, controlled study
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 1966
VO 42
IS Suppl 57
A1 Diana Bilton
A1 Gregory Tino
A1 Alan Barker
A1 Daniel Chambers
A1 Anthony De Soyza
A1 Lieven Dupont
A1 Conor O'Dochartaigh
A1 Eric van Haren
A1 Luis Otero Vidal
A1 Tobias Welte
A1 Howard Fox
A1 Jian Wu
A1 Brett Charlton
YR 2013
UL http://erj.ersjournals.com/content/42/Suppl_57/1966.abstract
AB Bronchiectasis, characterised by abnormal bronchial dilatation, is associated with increased sputum production, impaired mucocilliary clearance, mucus accumulation, cough, & recurrent bacterial infection. Inhaled dry powder mannitol (M), an osmotic agent increases mucus clearance acutely & over 24hrs in patients with bronchiectasis, however long term data are needed.Aim: The primary study aim was to evaluate the difference in pulmonary exacerbations over 12mths between M & control (C). Secondary endpoints included: Time to first exacerbation, antibiotic use, SGRQ, 24hr sputum volume, Epworth Sleepiness Scale, lung function & safety.Methods: A randomised, double-blind, multicentre, phase III study in patients (18-85yr) with a confirmed diagnosis of non-CF bronchiectasis, FEV1 (40-85% predicted) & ≥ 1.0L. 485 patients (62.7% F), mean age (SD) 59.8 (13.6) were randomised (1:1) to M (400mg bd) or C (50 mg bd). Mean (SD) baseline FEV1% was 62.3% (13.5).Results: There was a non-significant 8% reduction (Rate ratio 0.92, p=0.31) in the rate of defined pulmonary exacerbations for patients treated with M vs. C. However there was a statistically significant 28% delay in time to first exacerbation (Hazard Ratio: 0.78, p=0.022) & a 24% reduction in days on antibiotics (Rate ratio 0.76, p=0.0496). SGRQ was significantly improved (-2.4, p=0.046).There was no difference in the number of patients experiencing adverse events (AEs) or serious AEs in the two groups.Conclusion: Although the primary endpoint failed to reach significance there are sufficient significant improvements in secondary endpoints to indicate the need for further evaluation of M in bronchiectasis.