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

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

Status
Withdrawn
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00446667
Enrollment
0
Registered
2007-03-13
Start date
2006-10-31
Completion date
2008-06-30
Last updated
2016-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Exacerbation

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.

Interventions

DRUGmannitol

400mg BD for 2 days

Sponsors

Syntara
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Pneumonia * CO2 retention

Design outcomes

Primary

MeasureTime frame
FEV12 days

Secondary

MeasureTime frame
safety2 days

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026