High Dose Inhaled Mannitol Study

A Pilot Study to Investigate the Feasibility and Tolerability of Inhaling a High Dose of Dry Powder Mannitol (IDPM) Per Breath Administered Via a Dry Powder Inhaler Loaded With a Single Capsule in Subjects With Bronchiectasis

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01076491

Enrollment

Registered

2010-02-26

Start date

2009-01-31

Completion date

2009-04-30

Last updated

2010-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiectasis

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.

Interventions

DRUGmannitol

inhaled mannitol - single doses of either 70 mg or 90 mg

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
emitted dose	single measure

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026