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

This study has been withdrawn prior to enrollment.
(Failed to recruit)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00446667
First Posted: March 13, 2007
Last Update Posted: September 28, 2016
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.
Information provided by:
Pharmaxis
  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: None (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 ]

Enrollment: 0
Study Start Date: October 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: mannitol
400mg BD for 2 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pneumonia
  • CO2 retention
  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): 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

ClinicalTrials.gov Identifier: NCT00446667     History of Changes
Other Study ID Numbers: DPM-COPD-HIP-101b
First Submitted: March 12, 2007
First Posted: March 13, 2007
Last Update Posted: September 28, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs