High Dose Inhaled Mannitol Study

Phase 1

Completed

• Conditions: Bronchiectasis

• Registration Number: NCT01076491
• Lead Sponsor: Syntara

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-03
• Study Completion: 2009-04
• Study First Submitted: 2009-11-11
• Status Verified: 2010-02
• Study First Submitted QC: 2010-02-24
• Last Update Submitted: 2010-02-24
• Study First Posted: 2010-02-26
• Last Update Posted: 2010-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
emitted dose	single measure

Trial Locations

Locations (1)

Royal Prince Alfred Hospital; 🇦🇺 Sydney, New South Wales, Australia