Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000354684
Ethics application status
Approved
Date submitted
7/09/2005
Date registered
9/09/2005
Date last updated
9/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical Application of exhaled Nitric Oxide measurements in PrimarY care
Scientific title
Assessing the utility of exhaled nitric oxide measurements in the diagnosis of asthma and the monitoring of inhaled steroid treatment in primary care
Universal Trial Number (UTN)
Trial acronym
CANOPY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 448 0
Condition category
Condition code
Respiratory 525 525 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Algorithms based on previous research are used to guide diagnostic and treatment decision making in patients with asthma in primary care. Patients will be followed up at 3 month intervals for one year using the algorithm to guide clinical decisions making regarding inhaled steroid dose.
Intervention code [1] 395 0
None
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 602 0
Change in asthma control questionnaire scores.
Timepoint [1] 602 0
At baseline and at the end of one year.
Primary outcome [2] 603 0
Change in asthma quality of life questionnaire scores.
Timepoint [2] 603 0
At baseline and at the end of one year.
Secondary outcome [1] 1265 0
Change in overall dose of inhaled corticosteroid prescribed.
Timepoint [1] 1265 0
Secondary outcome [2] 1266 0
Total use of oral steroids.
Timepoint [2] 1266 0
The total steroid doses will be compared for the year prior to study entry and the year of participation in the study.

Eligibility
Key inclusion criteria
Diagnostic arm: Inclusion - patients over 12yrs old with wheeze, cough or dyspnoea for >6weeks duration. Treatment arm: Inclusion - asthmatic patients >12yrs old.
Minimum age
12 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion for both arms current or recent ex-smokers (<6months).

Study design
Purpose of the study
Diagnosis
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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 182 0
New Zealand
State/province [1] 182 0

Funding & Sponsors
Funding source category [1] 584 0
University
Name [1] 584 0
University of Otago
Country [1] 584 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 473 0
Hospital
Name [1] 473 0
Mornington Health Centre Dunedin
Address [1] 473 0
Country [1] 473 0
New Zealand

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35650 0
Address 35650 0
Country 35650 0
Phone 35650 0
Fax 35650 0
Email 35650 0
Contact person for public queries
Name 9584 0
Dr Richard Hewitt
Address 9584 0
Otago Respiratory Research Group
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin
Country 9584 0
New Zealand
Phone 9584 0
+64 3 4740999 (Ext. 8785)
Fax 9584 0
Email 9584 0
[email protected]
Contact person for scientific queries
Name 512 0
Professor D Robin Taylor
Address 512 0
Otago Respiratory Research Group
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin
Country 512 0
New Zealand
Phone 512 0
+64 3 4740999 (Ext. 8785)
Fax 512 0
Email 512 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.