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Trial registered on ANZCTR


Registration number
ACTRN12605000686606
Ethics application status
Approved
Date submitted
16/09/2005
Date registered
24/10/2005
Date last updated
20/12/2018
Date data sharing statement initially provided
20/12/2018
Date results information initially provided
20/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised, controlled trial of two different algorithms for maintaining asthma control during down titration on long acting bronchodilators and inhaled corticosteroids (CRC P7S3)
Scientific title
A randomised, controlled trial of two different algorithms for maintaining asthma control during down titration on long acting bronchodilators and inhaled corticosteroids
Secondary ID [1] 204 0
CRC for Asthma
Universal Trial Number (UTN)
Trial acronym
CRC P7 S3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 834 0
Condition category
Condition code
Respiratory 902 902 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project is to assess the relative effectiveness of two clinically applicable algorithms to guide titration of ICS therapy in subjects with asthma. The effectiveness of the algorithm will be assessed in terms of its capacity to minimise long-term ICS (and oral steroid) usage while maintaining optimal asthma control (asthma-free days and quality of life).Down titration of ICS according to pre-set clinical criteria for well controlled asthma (usual care) or levels of exhaled nitric oxide (eNo).
Intervention code [1] 631 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1167 0
Asthma free days
Timepoint [1] 1167 0
Participants will visit the clinic to be evaluted every 2 months for 8 months.
Primary outcome [2] 1168 0
Quality of life
Timepoint [2] 1168 0
Participants will visit the clinic to be evaluted every 2 months for 8 months.
Secondary outcome [1] 2140 0
Total exacerbations
Timepoint [1] 2140 0
Over 8 months
Secondary outcome [2] 2141 0
Mean steroid dose (oral and inhaled)
Timepoint [2] 2141 0
Measured every 2 months for 8 months.
Secondary outcome [3] 2142 0
Asthma control questionnaire score
Timepoint [3] 2142 0
Measured every 2 months for 8 months.
Secondary outcome [4] 2143 0
Clinic FEV1
Timepoint [4] 2143 0
Measured every 2 months for 8 months.
Secondary outcome [5] 2144 0
Mean morning PEF
Timepoint [5] 2144 0
2 weeks before and after dose changes
Secondary outcome [6] 2145 0
AHR
Timepoint [6] 2145 0
Measured every 2 months for 8 months.
Secondary outcome [7] 2146 0
eNo
Timepoint [7] 2146 0
Measured every 2 months for 8 months.
Secondary outcome [8] 2147 0
Symptom score
Timepoint [8] 2147 0
Measured every 2 months for 8 months.
Secondary outcome [9] 2148 0
Reliever use.
Timepoint [9] 2148 0
Measured every 2 months for 8 months.

Eligibility
Key inclusion criteria
Asthma must be well controlled over the two weeks prior to entry on ICS > 100 mcgs fluticasone or equivalent daily + LABA (salmeterol or formoterol), with medication dose stable for four weeks prior to entry. a.FEV1 criterion for well controlled asthma at entry: FEV1 must be within 10% of the best within the last 2 years, and equal to or above 65% of predicted FEV1 b.Maximum reliever use must be 3 times weekly (excluding prophylactic use for exercise) at Visit 1.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This will be achieved by the research assistant or investigator at each site providing the results of the assessment of control for both algorithms to a third person not directly involved in the study. This person will consult the randomisation code and a medical practitioner will submit a request to pharmacy for the appropriate study medication based on the subject's allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software SAS-Randomized 1:1 within each site (4 sites) and the packs were randomly numbered in blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 994 0
Other
Name [1] 994 0
Woolcock Institute of Medical Research
Address [1] 994 0
Country [1] 994 0
Australia
Funding source category [2] 995 0
Other Collaborative groups
Name [2] 995 0
CRC for Asthma
Address [2] 995 0
Country [2] 995 0
Australia
Primary sponsor type
Other
Name
CRC for Asthma
Address
Country
Australia
Secondary sponsor category [1] 856 0
Other
Name [1] 856 0
Woolcock Institute of Medical Research
Address [1] 856 0
Country [1] 856 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2299 0
The Alfred Hospital
Ethics committee address [1] 2299 0
Ethics committee country [1] 2299 0
Date submitted for ethics approval [1] 2299 0
01/03/2005
Approval date [1] 2299 0
01/03/2005
Ethics approval number [1] 2299 0
Ethics committee name [2] 2300 0
John Hunter Hospital
Ethics committee address [2] 2300 0
Ethics committee country [2] 2300 0
Date submitted for ethics approval [2] 2300 0
01/03/2005
Approval date [2] 2300 0
01/03/2005
Ethics approval number [2] 2300 0
Ethics committee name [3] 2301 0
Liverpool Hospital
Ethics committee address [3] 2301 0
Ethics committee country [3] 2301 0
Date submitted for ethics approval [3] 2301 0
01/03/2005
Approval date [3] 2301 0
Ethics approval number [3] 2301 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Estimate - details unknown
Public notes

Contacts
Principal investigator
Name 35454 0
Address 35454 0
Country 35454 0
Phone 35454 0
Fax 35454 0
Email 35454 0
Contact person for public queries
Name 9820 0
Ms Wendy Taylor
Address 9820 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9820 0
Australia
Phone 9820 0
+61 2 95156578
Fax 9820 0
+61 2 95505065
Email 9820 0
volunteers@woolcock.org.au
Contact person for scientific queries
Name 748 0
Professor Christine Jenkins
Address 748 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 748 0
Australia
Phone 748 0
+61 2 95157928
Fax 748 0
+61 2 95505865
Email 748 0
crj@woolcock.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary