Overview

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