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High Dose Inhaled Mannitol Study

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.
ClinicalTrials.gov Identifier: NCT01076491
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : February 26, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Drug: mannitol Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official 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
Study Start Date : January 2009
Primary Completion Date : March 2009
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Mannitol
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: mannitol
    inhaled mannitol - single doses of either 70 mg or 90 mg

Outcome Measures

Primary Outcome Measures :
  1. emitted dose [ Time Frame: single measure ]

Eligibility Criteria

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:   No
Criteria

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
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): NCT01076491


Locations
Australia, New South Wales
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Sponsors and Collaborators
Pharmaxis
More Information

Responsible Party: Dr Brett Charlton, Pharmaxis
ClinicalTrials.gov Identifier: NCT01076491     History of Changes
Other Study ID Numbers: DPM-DEV-102b
DPM-DEV-102b ( Other Identifier: Pharmaxis Ltd )
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: February 26, 2010
Last Verified: February 2010

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