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Sponsored by: |
Pharmaxis |
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Information provided by: | Pharmaxis |
ClinicalTrials.gov Identifier: | NCT00446667 |
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 |
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COPD Exacerbation |
Drug: mannitol |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | A Pilot Safety Study of Inhaled Dry Powder Mannitol in Acute Exacerbations of COPD |
Estimated Enrollment: | 25 |
Study Start Date: | October 2006 |
Study Completion Date: | June 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: mannitol
400mg BD for 2 days
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Ages Eligible for Study: | 35 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia, New South Wales | |
Royal Prince Alfred Hospital | |
Sydney, New South Wales, Australia, 2087 | |
St George Hospital | |
Sydney, New South Wales, Australia |
Principal Investigator: | David Barnes, MBBS FRACP | Royal Prince Alfred Hospital NSW Australia |
Study ID Numbers: | DPM-COPD-HIP-101b |
Study First Received: | March 12, 2007 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00446667 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Lung Diseases, Obstructive Respiratory Tract Diseases Mannitol Lung Diseases Pulmonary Disease, Chronic Obstructive |
Natriuretic Agents Therapeutic Uses Diuretics, Osmotic Physiological Effects of Drugs |
Diuretics Cardiovascular Agents Pharmacologic Actions |