Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000016538
Ethics application status
Approved
Date submitted
6/12/2005
Date registered
10/01/2006
Date last updated
10/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
COAST study
Scientific title
Chronic Obstructive Pulmonary Disease (COPD) Observational and Surveillance Trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 977 0
Condition category
Condition code
Respiratory 1052 1052 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
NIL
Intervention code [1] 789 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 1407 0
Assemble a prospective cohort of patients with COPD in Victoria
Timepoint [1] 1407 0
Secondary outcome [1] 2487 0
Provide information on the prevalence of virus infections in health and during exacerbations.
Will yield new knowledge about mechanisms implicated in the progressive loss of lung function in COPD
Timepoint [1] 2487 0

Eligibility
Key inclusion criteria
COPD diagnosisFEV1 < 70% predictedReversibility following SABA on predicted FEV1of <10% and/or 200mls.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to tolerate any study procedures.Inability to attend clinic and fill out daily diary.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1149 0
Self funded/Unfunded
Name [1] 1149 0
Country [1] 1149 0
Primary sponsor type
Individual
Name
A/Professor Peter Holmes
Address
Country
Secondary sponsor category [1] 1006 0
Individual
Name [1] 1006 0
A/Prof Philip Bardin
Address [1] 1006 0
Country [1] 1006 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2472 0
Monash Medical Centre Department of Respiratory and Sleep Medicine
Ethics committee address [1] 2472 0
Level 2, 246 Clayton Rd, Clayton, VIC, 3168
Ethics committee country [1] 2472 0
Australia
Date submitted for ethics approval [1] 2472 0
Approval date [1] 2472 0
Ethics approval number [1] 2472 0

Summary
Brief summary
This study over a 2 year period will aim to identify viruses during COPD attacks and try to understand whether they also damage the airway in the process. This is done by assessing lung function, nasal and sputum samples both when well and during an exacerbation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36369 0
Address 36369 0
Country 36369 0
Phone 36369 0
Fax 36369 0
Email 36369 0
Contact person for public queries
Name 9978 0
Ms Joanne McKenzie
Address 9978 0
Department of Respiratory and Sleep Medicine
Monash Medical Centre
Level 2
246 Clayton Rd
Clayton VIC 3168
Country 9978 0
Australia
Phone 9978 0
+61 3 95942279
Fax 9978 0
+61 3 95947877
Email 9978 0
[email protected]
Contact person for scientific queries
Name 906 0
Associate Professor Peter Holmes
Address 906 0
Department of Respiratory and Sleep Medicine
Monash Medical Centre
Level 2
246 Clayton Rd
Clayton VIC 3168
Country 906 0
Australia
Phone 906 0
+61 3 95942907
Fax 906 0
+61 3 95947877
Email 906 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.