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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00446667




Registration number
NCT00446667
Ethics application status
Date submitted
12/03/2007
Date registered
13/03/2007
Date last updated
28/09/2016

Titles & IDs
Public title
A Pilot Safety Study of Inhaled Dry Powder Mannitol in Acute Exacerbations of COPD
Scientific title
A Pilot Safety Study of Inhaled Dry Powder Mannitol in Acute Exacerbations of COPD
Secondary ID [1] 0 0
DPM-COPD-HIP-101b
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 0 0
Exacerbation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - mannitol

Experimental: 1 -


Treatment: Drugs: mannitol
400mg BD for 2 days

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
FEV1
Timepoint [1] 0 0
2 days
Secondary outcome [1] 0 0
safety
Timepoint [1] 0 0
2 days

Eligibility
Key inclusion criteria
- FEV1 > 35% predicted

- COPD

- Exacerbation

- Inpatient
Minimum age
35 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pneumonia

- CO2 retention

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [2] 0 0
St George Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2087 - Sydney
Recruitment postcode(s) [2] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pharmaxis
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00446667
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Barnes, MBBS FRACP
Address 0 0
Royal Prince Alfred Hospital NSW Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00446667