Study Title: A phase III multicenter, randomized, parallel group, controlled, double blind study to investigate the safety and efficacy of inhaled mannitol over 12 months in treatment of bronchiectasis
Short Title: Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis
Sponsor: Pharmaxis Ltd.
Principal Investigator: Anne O’Donnell, MD
To examine the efficacy and safety of 52 weeks treatment with inhaled mannitol in subjects with non-cystic fibrosis bronchiectasis. Previous studies have shown patients with bronchiectasis who have been treated with mannitol have shown an improvement in quality of life, less need for antibiotics and are able to clear more mucus from their lungs. The information from this study may help to treat people with bronchiectasis in the future.
Study participants will receive either inhaled mannitol or placebo-control (a “dummy” study medication, that is, although it looks and tastes like mannitol, it will not have an effect on respiratory symptoms). The study consists of 9 visits over 57- 63 weeks.
Key Inclusion Criteria
- Age between 18 and 80 years
- Diagnosed with (non-cystic fibrosis) bronchiectasis
- Documented history of at least 2 pulmonary exacerbations, each requiring antibiotic therapy, in the last 12 months prior to study entry and an average of at least 4 in the last 2 years prior to study entry
Key Exclusion Criteria
- Have bronchiectasis as a consequence of cystic fibrosis or otherwise curable causes (e.g. foreign body aspiration)
- Be considered “terminally ill” or listed for transplantation
For more information regarding eligibility:
Please see ClinicalTrials.gov (Identifier: NCT00669331)
Or call Michele Cooney at 202-444-4982