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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Agents
Diuretics
Diuretics, Osmotic
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014