A phase III multicenter, randomized, parallel, controlled, double blind study to investigate the safety and efficacy of inhaled mannitol over 12 months in the treatment of bronchiectasis.
- Conditions
- Bronchiectasis10006436
- Registration Number
- NL-OMON34341
- Lead Sponsor
- Pharmaxis Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
1. Have given a written informed consent to participate in this study in accordance with local regulations
2. Confirmed diagnosis of (non-cystic fibrosis) bronchiectasis (diagnosed by CT, HRCT, or bronchogram)
3. Aged 18*85 years, male and female
4. FEV1 >40 and *85 % predicted and > 1.0L
5. Clinician documented history of at least 2 pulmonary exacerbations, each requiring antibiotic therapy, in the last 12 months prior to Visit 0A and a total of at least 4 in the last 2 years prior to Visit 0A
6. Total SGRQ score of *30 at Visit 0B
7. 24 hour sputum weight *10g at Visit 0B
1. Have bronchiectasis as a consequence of cystic fibrosis or focal endobronchial lesion or otherwise curable causes (e.g. foreign body aspiration)
2. Be considered *terminally ill* or listed for transplantation
3. Be using hypertonic saline in the 14 days prior to commencing Visit 0B or thereafter at any time during the study
4. Have had rescue antibiotics in the 4 weeks prior to V0B (chronic background antibiotic therapy accepted)
5. Have smoked within the last 3 months and must not smoke during their participation in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint: Pulmonary exacerbation rates (graded exacerbations)</p><br>
- Secondary Outcome Measures
Name Time Method