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Trial registered on ANZCTR


Registration number
ACTRN12610000039088
Ethics application status
Approved
Date submitted
12/01/2010
Date registered
13/01/2010
Date last updated
10/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Lung function measurement to predict the response to changes in the dose of inhaled corticosteroids among asthmatic patients taking combination therapy
Scientific title
Lung function measurement to predict the response to changes in the dose of inhaled corticosteroids among asthmatic patients taking combination therapy
Secondary ID [1] 1267 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 256508 0
Lung function 256509 0
Condition category
Condition code
Respiratory 256676 256676 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Measurement of lung function at baseline and at review (spirometry, lung volumes).
Measurement of lung biomarkers at baseline and at review (exhaled nitric oxide, multiple breath nitrogen washout, forced oscillation device, sputum induction).
Dose adjustment of inhaled corticosteroids based on baseline level of asthma control. The frequency of the medication treatment remains the same for each individual patient as it was prior to entry into the study:
If patients are not well-controlled at baseline, then the inhaled corticosteroid dose will be doubled over the 8-week period.
If patients are well-controlled at baseline, the inhaled corticosteroid dose will be halved in the first 4 weeks and quartered over the subsequent 4 weeks. Patients are reviewed at the end of the 8-week period. If patients remain well-controlled after the initial 8-week period, then patients can stop their inhaled corticosteroid and continue to be monitored over another 8-week period.

Patients can return for review if their asthma control worsens at any stage during the study. This is an end-point for the study. In this instance, patients are treated as clinically indicated and will return to the care of their usual treating doctor after the study.
Intervention code [1] 255788 0
Treatment: Drugs
Comparator / control treatment
This is an open label physiological study. Subjects will continue to take the same brand of inhaled corticosteroids during the study as they did prior to entry into the study. The dose adjustment of the inhaled corticosteroids is the only intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257564 0
To detect a change in the level of asthma control during the study period measured by the Asthma Control Questionnaire (ACQ).
Timepoint [1] 257564 0
8 or 16 weeks from baseline
Primary outcome [2] 257570 0
To compare the sensitivity and specificity of the following baseline measurements:
Severity of airway hyperresponsiveness to mannitol, measured by forced oscillation device (FOT) or spirometry;
Ventilation heterogeneity, measured by multiple breath nitrogen washout;
Exhaled nitric oxide; and
Sputum inflammatory cells
to predict:
a) optimization of asthma control following 8 weeks of increased treatment with combination therapy
b) loss of asthma control over 8 weeks when the dose of combination therapy is reduced
Timepoint [2] 257570 0
8 or 16 weeks from baseline
Secondary outcome [1] 262810 0
The baseline measurements will be repeated at the end of the study period to provide alternative measures of asthma control, to be used in secondary analyses.
Timepoint [1] 262810 0
8 or 16 weeks from baseline

Eligibility
Key inclusion criteria
Adult
Physician-diagnosed asthma
Not currently smoking
Active asthma requiring preventor medication
Minimum age
17 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Smoking
Intubation due to severe asthma exacerbation

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)
This is a non-randomised trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dose adjustment of the inhaled corticosteroid at baseline is based on baseline asthma control in accordance with current clinical guidelines.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is an open label physiological study in asthma.
The frequency of the medication treatment remains the same for each individual patient as it was prior to entry into the study:
If patients are not well-controlled at baseline, then the inhaled corticosteroid dose will be doubled over the 8-week period.
If patients are well-controlled at baseline, the inhaled corticosteroid dose will be halved in the first 4 weeks and quartered over the subsequent 4 weeks. Patients are reviewed at the end of the 8-week period. If patients remain well-controlled after the initial 8-week period, then patients can stop their inhaled corticosteroid and continue to be monitored over another 8-week period.

Patients can return for review if their asthma control worsens at any stage during the study. This is an end-point for the study. In this instance, patients are treated as clinically indicated and will return to the care of their usual treating doctor after the study.
Phase
Not Applicable
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2381 0
2139

Funding & Sponsors
Funding source category [1] 256273 0
Other Collaborative groups
Name [1] 256273 0
Coperative Research Center (CRC) for Asthma and Airways
Country [1] 256273 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Woolcock Institute of Medical Research
Address
Airway Physiology Group
431 Glebe Point Road, Glebe NSW 2037
Mailing Address:
PO Box M77
Missenden Rd, Camperdown, NSW 2050
Australia
Country
Australia
Secondary sponsor category [1] 251599 0
None
Name [1] 251599 0
Address [1] 251599 0
Country [1] 251599 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258363 0
Northern Sydney Central Coast Area Health Service (NSCCAHS)
Ethics committee address [1] 258363 0
The Research Office
Level 2, Building 51
Royal North Shore Hospital
St Leonards, NSW, 2065
Ethics committee country [1] 258363 0
Australia
Date submitted for ethics approval [1] 258363 0
28/10/2008
Approval date [1] 258363 0
13/02/2009
Ethics approval number [1] 258363 0
0812-253M

Summary
Brief summary
The aim of the study is to evaluate the ability of various physiological and inflammatory markers to predict changes in asthma control following changes in the dose of combination therapy. The direction and magnitude of the dose changes are determined for each patient by their baseline level of asthma control. If the baseline variables, either alone or in combination, can predict future benefit or risk from change in treatment then the study will provide new insights into the clinical management of asthma.
Trial website
http://www.woolcock.org.au/PDF/Current_clinical_trials/Airways/09_Apr_AsthmaLF_A4_WIMR.pdf
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30683 0
Address 30683 0
Country 30683 0
Phone 30683 0
Fax 30683 0
Email 30683 0
Contact person for public queries
Name 13930 0
Dr Claude Farah
Address 13930 0
Airway Physiology Group
PO Box M77
Missenden Road, Camperdown, NSW, 2050
Country 13930 0
Australia
Phone 13930 0
+61 2 91140149
Fax 13930 0
+61 2 91140014
Email 13930 0
cfarah@med.usyd.edu.au
Contact person for scientific queries
Name 4858 0
Dr Claude Farah
Address 4858 0
Airway Physiology Group
PO Box M77
Missenden Road, Camperdown, NSW, 2050
Country 4858 0
Australia
Phone 4858 0
+61 2 91140149
Fax 4858 0
+61 2 91140014
Email 4858 0
cfarah@med.usyd.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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAssociation between peripheral airway function and neutrophilic inflammation in asthma.2015https://dx.doi.org/10.1111/resp.12550
N.B. These documents automatically identified may not have been verified by the study sponsor.