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

NCT ID: NCT00446667

Last Updated: 2016-09-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-06-30

Brief 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.

Conditions

COPD; Exacerbation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

mannitol

Intervention Type: DRUG

400mg BD for 2 days

Interventions

mannitol

400mg BD for 2 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Pneumonia
• CO2 retention

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syntara

INDUSTRY

Sponsor Role: lead

Principal Investigators

David Barnes, MBBS FRACP

Role: PRINCIPAL_INVESTIGATOR

Royal Prince Alfred Hospital NSW Australia

Locations

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

St George Hospital

Sydney, New South Wales, Australia

Countries

Australia

Other Identifiers

DPM-COPD-HIP-101b

Identifier Type: -

Identifier Source: org_study_id