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NCT00730977 Clinical Trial

A Pilot Study to Investigate Administration of Mannitol Via a Novel Dry Powder Inhaler Device

Healthy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00730977
Other study ID # DPM-DEV-101b
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received August 5, 2008
Last updated September 17, 2009
Start date August 2008
Est. completion date September 2008

Study information
Verified date September 2009
Source Pharmaxis
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- healthy or bronchiectatic; 18 years and over

Exclusion Criteria:

- uncontrolled asthma, unstable

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• dry powder inhaled mannitol
single doses of 40 mg, 70 mg and 100 mg

Locations
Country Name City State
Australia Royal Prince Alfred Hospital Sydney

Sponsors (1)
Lead Sponsor Collaborator
Pharmaxis

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary tolerability immediately and 10 mins post dose Yes
Secondary respiratory symptoms, FEV1 pre-dose, immediately and 10 mins post dose Yes
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