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A Pilot Safety Study of Inhaled Dry Powder Mannitol in Acute Exacerbations of COPD

This study has been completed.
Sponsor:
Information provided by:
Pharmaxis
ClinicalTrials.gov Identifier:
NCT00446667
First received: March 12, 2007
Last updated: August 27, 2008
Last verified: August 2008
  Purpose

COPD is a major cause of ill health and death in Australia with 40,000 hospital admissions, and a national cost of $898,000,000 annually. The gold standard treatment of COPD is steroids for inflammation, antibiotics for infection and bronchodilators and oxygen for respiratory failure. However, associated mucus hypersecretion is responsible for much of the inflammation and infection. The use of pharmaceutical agents to assist in the early clearance of the retained mucus has been limited, primarily because of lack of demonstrated effect. There has been a recent development of interest in pursuing new therapies for improving mucociliary clearance and several studies have demonstrated that clinical outcomes can be improved when osmotic agents such as mannitol are added to standard treatments. The purpose of this study is to conduct a pilot safety study in patients with an acute exacerbation of COPD to determine if it is safe to administer inhaled mannitol for facilitating mucus clearance.


Condition Intervention Phase
COPD
Exacerbation
Drug: mannitol
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Safety Study of Inhaled Dry Powder Mannitol in Acute Exacerbations of COPD

Resource links provided by NLM:


Further study details as provided by Pharmaxis:

Primary Outcome Measures:
  • FEV1 [ Time Frame: 2 days ]

Secondary Outcome Measures:
  • safety [ Time Frame: 2 days ]

Estimated Enrollment: 25
Study Start Date: October 2006
Study Completion Date: June 2008
Arms Assigned Interventions
Experimental: 1 Drug: mannitol
400mg BD for 2 days

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • FEV1 > 35% predicted
  • COPD
  • Exacerbation
  • Inpatient

Exclusion Criteria:

  • Pneumonia
  • CO2 retention
  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: NCT00446667

Locations
Australia, New South Wales
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2087
St George Hospital
Sydney, New South Wales, Australia
Sponsors and Collaborators
Pharmaxis
Investigators
Principal Investigator: David Barnes, MBBS FRACP Royal Prince Alfred Hospital NSW Australia
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00446667     History of Changes
Other Study ID Numbers: DPM-COPD-HIP-101b
Study First Received: March 12, 2007
Last Updated: August 27, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on November 25, 2014