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
ACTRN12605000313639
Ethics application status
Approved
Date submitted
1/09/2005
Date registered
6/09/2005
Date last updated
6/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bronchoscopy and Airway Disease in Children
Scientific title
An observational cohort study of the severity of respiratory illness in children with malacia defined quantitatively by bronchoscopy
Secondary ID [1] 138 0
Floppy airways study
Universal Trial Number (UTN)
Trial acronym
FAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malacia disorders of childhood 401 0
Condition category
Condition code
Respiratory 472 472 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Bronchoscopic measurement of airway lesions and 2 year observational followup with questionnaire.
Intervention code [1] 329 0
Prevention
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 536 0
Quantification of airway lesions at study entry
Timepoint [1] 536 0
Primary outcome [2] 537 0
Associated clincal progress over 2 years
Timepoint [2] 537 0
Secondary outcome [1] 1142 0
Morbidity associated with malacia disorders
Timepoint [1] 1142 0
Defined at the end of the 2 yr follow-up.

Eligibility
Key inclusion criteria
Children with chronic cough, stirdor and wheeze
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with Cystic Fibrosis.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Case control
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 532 0
University
Name [1] 532 0
University of Queensland: PhD program
Country [1] 532 0
Australia
Primary sponsor type
University
Name
University of Queensland: PhD program
Address
Country
Australia
Secondary sponsor category [1] 432 0
University
Name [1] 432 0
University of Queensland: PhD program
Address [1] 432 0
Country [1] 432 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1532 0
Royal Children's Hospital Department of Child Health
Ethics committee address [1] 1532 0
Ethics committee country [1] 1532 0
Australia
Date submitted for ethics approval [1] 1532 0
Approval date [1] 1532 0
Ethics approval number [1] 1532 0

Summary
Brief summary
Project is Dr Masters PhD work on airway disease( malacia disorders) in children
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36195 0
Address 36195 0
Country 36195 0
Phone 36195 0
Fax 36195 0
Email 36195 0
Contact person for public queries
Name 9518 0
Dr IB Masters
Address 9518 0
Department of Respiratory Medicine
Royal Childrens Hospital
Herston Rd
Herston QLD 4029
Country 9518 0
Australia
Phone 9518 0
+61 7 36369047
Fax 9518 0
+61 7 36361958
Email 9518 0
[email protected]
Contact person for scientific queries
Name 446 0
Dr IB Masters
Address 446 0
Department of Respiratory Medicine
Royal Childrens Hospital
Herston Rd
Herston QLD 4029
Country 446 0
Australia
Phone 446 0
+61 7 36369047
Fax 446 0
+61 7 36361958
Email 446 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.