High Dose Inhaled Mannitol Study

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to investigate the safety and tolerability of high doses of inhaled mannitol in subjects with bronchiectasis to further direct development of an improved drug delivery system.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmaxis
• Treatments: Mannitol

Criteria

Inclusion Criteria:

• adult subjects with non-CF bronchiectasis

• FEV1 > 50 % predicted and > 1.0L

Exclusion Criteria:

• bronchiectasis due to CF or endobronchial lesion

• respiratory infection requiring IV antibiotics in last 4 weeks

• pregnancy

• significant haemoptysis in last 6 months

• active TB

• end stage ILD

• contraindications as determined by investigator