Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000602628
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
5/10/2005
Date last updated
5/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of CF Patient Perception of Symptom Improvement Following Inhaled Antibiotic Treatment
Scientific title
Evaluation of CF Patient Perception of Symptom Improvement Following Inhaled Antibiotic Treatment
Universal Trial Number (UTN)
Trial acronym
MCID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis (CF) 731 0
Condition category
Condition code
Human Genetics and Inherited Disorders 809 809 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of Inhaled Tobramycin Solution (TOBI) for a period of 28 days.
Intervention code [1] 578 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1037 0
To determine the responsiveness of the Cystic Fibrosis Questionnaire-Revised (CFQ-R) by determination of the minimal clinically important difference score (MCID) in children/parents and adolescents/adults with CF receiving Tobramycin solution for inhalation (TOBI).
Timepoint [1] 1037 0
Measured upon completion of a 28 day course of Tobramycin, and again 14 days post completion.
Secondary outcome [1] 1932 0
To correlate change in clinical symptoms as measured by the CFQ-R with change in pulmonary function and the Global Rating of Change Questionnaire.
Timepoint [1] 1932 0
This will be measured upon completion of a 28 day course of Tobramycin, and again 14 days post completion.

Eligibility
Key inclusion criteria
Diagnosis of CF and chronic PA infection (defined as cultures positive for PA for > 6 months, including most recent culture). Have adequate understanding of English to give informed consent and follow study procedures. Patient must have completed their most recent course of TOBI or aerosolized tobramycin solution or any other aerosolized antibiotic at least 28 days prior to study entry. Parent/guardian of children 6 to 13 years old must agree to complete the CFQ-R and Global Rating of Change Questionnaires. Patient's physician must have decided to prescribe a 28 day course of TOBI for treatment of clinical symptoms (increased cough, increased sputum production/chest congestion, decreased exercise tolerance, or decreased appetite).
Minimum age
6 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/07/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 895 0
Commercial sector/Industry
Name [1] 895 0
Corus Pharma
Country [1] 895 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Corus Pharma
Address
Country
Denmark
Secondary sponsor category [1] 757 0
None
Name [1] 757 0
N/A
Address [1] 757 0
Country [1] 757 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2180 0
Royal Children's Hospital and Health Service District,
Ethics committee address [1] 2180 0
Ethics committee country [1] 2180 0
Australia
Date submitted for ethics approval [1] 2180 0
Approval date [1] 2180 0
Ethics approval number [1] 2180 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35366 0
Address 35366 0
Country 35366 0
Phone 35366 0
Fax 35366 0
Email 35366 0
Contact person for public queries
Name 9767 0
Mr Aaron Buckner
Address 9767 0
Sir Albert Sakzewski Virus Research Centre
Royal Children's Hospital and Health Service District
Herston Road
Herston QLD 4029
Country 9767 0
Australia
Phone 9767 0
+61 7 36361567
Fax 9767 0
+61 7 36365371
Email 9767 0
[email protected]
Contact person for scientific queries
Name 695 0
Dr Claire Wainwright
Address 695 0
Respiratory Department
Royal Children's Hospital and health Service District
3rd Floor
Woolworths Building
Herston Road
Herston QLD 4029
Country 695 0
Australia
Phone 695 0
+61 7 36368111 pager 58971
Fax 695 0
+61 7 36361958
Email 695 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
SourceTitleYear of PublicationDOI
EmbaseDetermination of the minimal clinically important difference scores for the cystic fibrosis questionnaire-revised respiratory symptom scale in two populations of patients with cystic fibrosis and chronic Pseudomonas aeruginosa airway infection.2009https://dx.doi.org/10.1378/chest.08-1190
N.B. These documents automatically identified may not have been verified by the study sponsor.