Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis

Exclusion Criteria

• •1. Be investigators, site personnel directly affiliated with this study, or their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.
• •2. Have bronchiectasis as a consequence of cystic fibrosis or focal endobronchial lesion or otherwise curable causes (e.g. foreign body aspiration)
• •3. Be considered "terminally ill" or listed for transplantation
• •4. Be using hypertonic saline in the 14 days prior to commencing Visit 0B or thereafter at any time during the study
• •5. Have previously used inhaled mannitol (Bronchitol) for more than a day
• •6. Have had a significant episode of hemoptysis (\>60 mL) in the previous 6 months
• •7. Have had rescue antibiotics in the 4 weeks prior to V0B (chronic background antibiotic therapy accepted)
• •8. Have smoked within the last 3 months and must not smoke during their participation in the study
• •9. Have had a myocardial infarction in the three months prior to Visit 0A
• •10. Have had a cerebral vascular accident in the three months prior to Visit 0A
• •11. Have had major ocular surgery in the three months prior to Visit 0A
• •12. Have had major abdominal, chest or brain surgery in the three months prior to Visit 0A
• •13. Have a known cerebral, aortic or abdominal aneurysm
• •14. Have actively treated Mycobacterium tuberculosis
• •15. Have actively treated or unstable nontuberculous mycobacterial (NTM)infection or be under consideration for NTM treatment in the next 12 months
• •16. Have unstable Allergic bronchopulmonary aspergillosis (ABPA) requiring steroid therapy (≤5mg dose oral steroids in stable ABPA accepted)
• •17. Have end stage interstitial lung disease
• •18. Have active malignancy including melanoma (other skin carcinomas exempted). Remissions from any malignancy ≥2 years also exempted
• •19. Be breast feeding or pregnant, or plan to become pregnant while in the study
• •20. Be using an unreliable form of contraception (female subjects at risk of pregnancy only)
• •21. Be participating in another investigational drug study, parallel to, or within 4 weeks of Visit 0A
• •22. Have a known intolerance to mannitol or β2-agonists
• •23. Have uncontrolled hypertension - e.g. for adults: systolic blood pressure (BP) \> 190 and or diastolic BP \> 100
• •24. Subject has a condition or is in a situation which in the Investigator's opinion may put the subject at significant risk, may confound results or may interfere significantly with the patient's participation in the study
• •25. Have previously been screen failed for the study (exceptions - see section 3.3.2 Eligibility Criteria - Rescreening)