Brief Title
A Pilot Study to Investigate Administration of Mannitol Via a Novel Dry Powder Inhaler Device
Official Title
A Pilot Study to Investigate the Tolerability of Inhaled Dry Powder Mannitol (IDPM) Administered Via a Novel Dry Powder Inhaler Device in Healthy Individuals and Subjects With Bronchiectasis.
Brief Summary
A novel dry powder inhaler device will be used to administer mannitol to healthy subjects and subjects with bronchiectasis in single doses higher than previously given.The main objective is to assess tolerability of these doses using the new device.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
tolerability
Secondary Outcome
respiratory symptoms, FEV1
Condition
Healthy
Intervention
dry powder inhaled mannitol
Study Arms / Comparison Groups
single
Description: single arm, open label, 4 doses tested.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
15
Start Date
August 2008
Completion Date
September 2008
Primary Completion Date
September 2008
Eligibility Criteria
Inclusion Criteria: - healthy or bronchiectatic; 18 years and over Exclusion Criteria: - uncontrolled asthma, unstable
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00730977
Organization ID
DPM-DEV-101b
Study Sponsor
Pharmaxis
Study Sponsor
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Verification Date
September 2009