NCT00446667

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

September 28, 2016

Status Verified

September 1, 2016

Enrollment Period

1.7 years

First QC Date

March 12, 2007

Last Update Submit

September 26, 2016

Conditions

COPDExacerbation

Outcome Measures

Primary Outcomes (1)

  • FEV1

    2 days

Secondary Outcomes (1)

  • safety

    2 days

Study Arms (1)

1

EXPERIMENTAL
Drug: mannitol

Interventions

mannitolDRUG

400mg BD for 2 days

1

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pneumonia
  • CO2 retention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal Prince Alfred Hospital

Sydney, New South Wales, 2087, Australia

Location

St George Hospital

Sydney, New South Wales, Australia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Mannitol

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • David Barnes, MBBS FRACP

    Royal Prince Alfred Hospital NSW Australia

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 12, 2007

First Posted

March 13, 2007

Study Start

October 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

September 28, 2016

Record last verified: 2016-09

Locations

AU(2)