High Dose Inhaled Mannitol Study

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.

Completed

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Key information

Conditions

Bronchiectasis Bronchial Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mannitol

Drug

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

Primary outcomes

emitted dose

Time frame: single measure

Sponsors and collaborators

Lead sponsor

Syntara

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Feb 26, 2010
Registry last updated: Feb 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed