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High Dose Inhaled Mannitol Study

This study has been completed.
Sponsor:
Information provided by:
Pharmaxis
ClinicalTrials.gov Identifier:
NCT01076491
First received: November 11, 2009
Last updated: February 24, 2010
Last verified: February 2010
History of Changes
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

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

Further study details as provided by Pharmaxis:

Primary Outcome Measures:
  • emitted dose [ Time Frame: single measure ] [ Designated as safety issue: No ]

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076491

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

No publications provided

Responsible Party: Dr Brett Charlton, Pharmaxis
ClinicalTrials.gov Identifier: NCT01076491     History of Changes
Other Study ID Numbers: DPM-DEV-102b, DPM-DEV-102b
Study First Received: November 11, 2009
Last Updated: February 24, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on May 22, 2013