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
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 11, 2009
CompletedFirst Posted
Study publicly available on registry
February 26, 2010
CompletedFebruary 26, 2010
February 1, 2010
2 months
November 11, 2009
February 24, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
emitted dose
single measure
Interventions
inhaled mannitol - single doses of either 70 mg or 90 mg
Eligibility Criteria
You may qualify if:
- adult subjects with non-CF bronchiectasis
- FEV1 \> 50 % predicted and \> 1.0L
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Syntaralead
Study Sites (1)
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 11, 2009
First Posted
February 26, 2010
Study Start
January 1, 2009
Primary Completion
March 1, 2009
Study Completion
April 1, 2009
Last Updated
February 26, 2010
Record last verified: 2010-02