Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000305325
Ethics application status
Approved
Date submitted
20/06/2008
Date registered
24/06/2008
Date last updated
26/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Developing a questionnaire to help doctors customise asthma management to the needs of individual patients
Scientific title
A study of adolescents and adults with asthma who are taking inhaled corticosteroid/long-acting beta-2-agonist inhalers (ICS/LABA), to develop a questionnaire to identify factors predicting poor asthma control
Secondary ID [1] 287962 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 3292 0
Condition category
Condition code
Respiratory 3454 3454 0 0
Asthma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Inhaled salmeterol/fluticasone. Participants will continue to use this medication at the same frequency and dose (or equivalent dose) as was previously prescribed by their own doctor. The duration of observation will be 8 weeks.
Intervention code [1] 3030 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4351 0
Questionnaire items that are most strongly associated with poor asthma control (Asthma Control Test score <20)
Timepoint [1] 4351 0
Timepoint for questionnaire: Week 0. Timepoint for assessment of asthma control: weeks 5-8
Secondary outcome [1] 7333 0
Forced expiratory volume in 1 second (FEV1) % predicted, measured according to European Respiratory Society/American Thoracic Society guidelines for spirometry.
Timepoint [1] 7333 0
Week 8

Eligibility
Key inclusion criteria
1. Age =14 yrs
2. Doctor diagnosis of asthma
3. Current prescription for salmeterol/fluticasone or formoterol/budesonide
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Recent asthma exacerbation (hospitalisation, Emergency Department visit, or steroid tablets for asthma in the previous month)
2. Other major respiratory disease e.g. COPD, or serious uncontrolled medical condition;
3. Patients who are pregnant or lactating or planning pregnancy in the next 2 months
4. Symbicort as Maintenance and Reliever Therapy

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/06/2008
Actual
29/07/2008
Date of last participant enrolment
Anticipated
Actual
25/11/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 3500 0
Charities/Societies/Foundations
Name [1] 3500 0
Asthma Foundation NSW
Country [1] 3500 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Woolcock Institute of Medical Research
Address
PO Box M77 Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 3143 0
None
Name [1] 3143 0
Address [1] 3143 0
Country [1] 3143 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5538 0
Sydney SouthWest Area Health Service Ethics Review Committee (RPAH zone)
Ethics committee address [1] 5538 0
Level 8, Building 14, Royal Prince Alfred Hospital, Missenden Rd, Camperdown NSW 2050
Ethics committee country [1] 5538 0
Australia
Date submitted for ethics approval [1] 5538 0
Approval date [1] 5538 0
02/06/2008
Ethics approval number [1] 5538 0

Summary
Brief summary
This project will develop a simple questionnaire to allow health care professionals to identify features contributing to poor asthma control, in patients who are currently using inhaled corticosteroid/long-acting b2-agonist combination inhaler.
Trial website
Trial related presentations / publications
Foster JM, Smith L, Bosnic-Anticevich SZ, Usherwood T, Sawyer SM, Rand CS, et al. Identifying patient-specific beliefs and behaviours for conversations about adherence in asthma. Intern Med J. 2012;42(6):e136-44.
Public notes

Contacts
Principal investigator
Name 28686 0
A/Prof Helen
Address 28686 0
Woolcock Institute of Medical Research
PO Box M77, Missenden Rd Post Office, NSW 2050
Country 28686 0
Australia
Phone 28686 0
+61 2 9114 0437
Fax 28686 0
Email 28686 0
helen.reddel@sydney.edu.au
Contact person for public queries
Name 11843 0
A/Prof Helen Reddel
Address 11843 0
Woolcock Institute of Medical Research, PO Box M77, Missenden Rd Camperdown NSW 2050.
Country 11843 0
Australia
Phone 11843 0
+61 2 9114 0437
Fax 11843 0
+61 2 9114 0014
Email 11843 0
helen.reddel@sydney.edu.au
Contact person for scientific queries
Name 2771 0
A/Prof Helen Reddel
Address 2771 0
Woolcock Institute of Medical Research, PO Box M77, Missenden Rd Camperdown NSW 2050.
Country 2771 0
Australia
Phone 2771 0
+61 2 9114 0437
Fax 2771 0
+61 2 9114 0014
Email 2771 0
helen.reddel@sydney.edu.au

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
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Documents added automatically
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