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Inhaled mannitol for non-cystic fibrosis bronchiectasis: a randomised, controlled trial
  1. Diana Bilton1,
  2. Gregory Tino2,
  3. Alan F Barker3,
  4. Daniel C Chambers4,5,
  5. Anthony De Soyza6,
  6. Lieven J A Dupont7,
  7. Conor O'Dochartaigh8,
  8. Eric H J van Haren9,
  9. Luis Otero Vidal10,
  10. Tobias Welte11,
  11. Howard G Fox12,
  12. Jian Wu12,
  13. Brett Charlton12
  14. for the B-305 Study Investigators
  1. 1Department of Respiratory Medicine, Royal Brompton Hospital, London, UK
  2. 2Department of Pulmonary, Allergy and Critical Care Division, University of Pennsylvania Medical Centre, Philadelphia, Pennsylvania, USA
  3. 3Division of Pulmonary and Critical Care Medicine, Oregon Health and Science University, Portland, Oregon, USA
  4. 4Queensland Lung Transplant Service, The Prince Charles Hospital, Chermside, Queensland, Australia
  5. 5School of Medicine, The University of Queensland, Herston, Queensland, Australia
  6. 6Institute of Cellular Medicine Newcastle University & Sir William Leech Centre, Freeman Hospital, Newcastle-upon-Tyne, UK
  7. 7UZL University Hospital Leuven, Leuven, Belgium
  8. 8Department of Respiratory Medicine, Middlemore Hospital, Auckland, New Zealand
  9. 9Atrium MC Pulmonology Department, Heerlen, The Netherlands
  10. 10Hospital Interzonal Especializado en Agudos y Cronicos "Dr Antonio A. Cetrangolo”, Partido de Vicente Lopez Provincia de Buenos Aires, Buenos Aires, Argentina
  11. 11Medizinische Hochschule Hannover, Klinik fur Pneumologie, Hannover, Germany
  12. 12Pharmaxis Ltd, Frenchs Forest, Sydney, NSW, Australia
  1. Correspondence to Professor Diana Bilton, Department of Respiratory Medicine, Royal Brompton Hospital, Sydney Street, London SW3 6NP, UK; d.bilton{at}rbht.nhs.uk

Abstract

Rationale Bronchiectasis 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.

Objectives To 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).

Methods Patients 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 results 461 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.

Conclusions Mannitol 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 number NCT00669331.

  • Bronchiectasis
  • Respiratory Infection

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