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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00446667
• Other study ID #: DPM-COPD-HIP-101b
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: March 12, 2007
• Last updated: September 26, 2016
• Start date: October 2006
• Est. completion date: June 2008

Study information

• Verified date: September 2016
• Source: Pharmaxis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• FEV1 > 35% predicted

• COPD

• Exacerbation

• Inpatient

Exclusion Criteria:

• Pneumonia

• CO2 retention

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Exacerbation

Intervention

Drug:
• mannitol
400mg BD for 2 days

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Sydney	New South Wales
Australia	St George Hospital	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Pharmaxis

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1		2 days
Secondary	safety		2 days