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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00730977
First Posted: August 8, 2008
Last Update Posted: September 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pharmaxis
  Purpose
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.

Condition Intervention Phase
Healthy Bronchiectasis Drug: dry powder inhaled mannitol Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
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.

Resource links provided by NLM:


Further study details as provided by Pharmaxis:

Primary Outcome Measures:
  • tolerability [ Time Frame: immediately and 10 mins post dose ]

Secondary Outcome Measures:
  • respiratory symptoms, FEV1 [ Time Frame: pre-dose, immediately and 10 mins post dose ]

Enrollment: 15
Study Start Date: August 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single
single arm, open label, 4 doses tested.
Drug: dry powder inhaled mannitol
single doses of 40 mg, 70 mg and 100 mg

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy or bronchiectatic; 18 years and over

Exclusion Criteria:

  • uncontrolled asthma, unstable
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00730977


Locations
Australia
Royal Prince Alfred Hospital
Sydney, Australia
Sponsors and Collaborators
Pharmaxis
  More Information

Responsible Party: Brett Charlton, Pharmaxis Ltd
ClinicalTrials.gov Identifier: NCT00730977     History of Changes
Other Study ID Numbers: DPM-DEV-101b
First Submitted: August 5, 2008
First Posted: August 8, 2008
Last Update Posted: September 18, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs