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High Dose Inhaled Mannitol Study

This study has been completed.
Information provided by:
Pharmaxis Identifier:
First received: November 11, 2009
Last updated: February 24, 2010
Last verified: February 2010
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 Intervention Phase
Bronchiectasis Drug: mannitol Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Pharmaxis:

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

Estimated Enrollment: 10
Study Start Date: January 2009
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: mannitol
    inhaled mannitol - single doses of either 70 mg or 90 mg

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01076491

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

Responsible Party: Dr Brett Charlton, Pharmaxis Identifier: NCT01076491     History of Changes
Other Study ID Numbers: DPM-DEV-102b
DPM-DEV-102b ( Other Identifier: Pharmaxis Ltd )
Study First Received: November 11, 2009
Last Updated: February 24, 2010

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs processed this record on August 23, 2017