Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000397617
Ethics application status
Approved
Date submitted
7/09/2005
Date registered
14/09/2005
Date last updated
19/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Towards better assessment and treatment of exercise induced wheeze
Scientific title
Comprehensive assessment of patients with exercise induced wheeze using pulmonary function testing, bronchial challenge testing (methacholine and Mannitol) and exhaled nitric oxide. A comparison of either inhaled steroids or a cross-over study of cromoglycate, montelukast and formoterol
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise induced wheeze 502 0
Asthma 503 0
Condition category
Condition code
Respiratory 581 581 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following comprehensive assessment, patients with exercise induced symptoms will be divided into two groups according to their baseline exhaled nitric oxide levels (FeNO). Those with a high FeNO (>35ppb) will receive inhaled fluticasone for 6 weeks.
Intervention code [1] 392 0
None
Comparator / control treatment
Those with a low FeNO (<35ppb) will enter a random-order, placebo-controlled cross-over study of montelukast, cromoglycate and formoterol (2 weeks each with a 1 week wash out between treatments).
Control group
Placebo

Outcomes
Primary outcome [1] 674 0
Each treatment will be deemed a success if, compared to baseline: 1. There is a >50% attenuation of any fall in FEV1 following exertion. 2. there is a 1 point improvement in the patient's Borg breathlessness scale. 3. There is a 0.5% improvement in a patient's asthma control questionnaire score. Baseline measurements will be compared with measurements taken at the conclusion of each treatment period.
Timepoint [1] 674 0
At baseline and at the conclusion of each treatment
Secondary outcome [1] 1381 0
The predictive accuracy of each of the baseline measurements will be computed for each of the three primary outcome measures, this time measured as continuous variables. Positive and negative predictive values will be derived from ROC curve analyses.
Timepoint [1] 1381 0
Comparisons will be made between baseline data and data collected at the end of each treatment period.

Eligibility
Key inclusion criteria
Exercise induced wheeze, cough or dyspnoea are the primary symptoms.
Minimum age
12 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current or recent ex-smokers, patients taking oral or inhaled steroids in the previous 6 weeks.

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)
Unmarked inhaler and tablet will be given for each 2 week treatment period with only one containing active ingredient. Allocation sequence in the formoterol, montelukast, cromoglycate arm will be implemented using sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order of the cross-over study will be decided using a latin square randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 179 0
New Zealand
State/province [1] 179 0

Funding & Sponsors
Funding source category [1] 633 0
Government body
Name [1] 633 0
Lottery Grants Board NZ
Country [1] 633 0
New Zealand
Funding source category [2] 634 0
Charities/Societies/Foundations
Name [2] 634 0
Asthma and Respiratory Foundation of NZ
Country [2] 634 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 518 0
None
Name [1] 518 0
none
Address [1] 518 0
Country [1] 518 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35113 0
Address 35113 0
Country 35113 0
Phone 35113 0
Fax 35113 0
Email 35113 0
Contact person for public queries
Name 9581 0
Dr Richard Hewitt
Address 9581 0
Otago Respiratory Research Unit
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin
Country 9581 0
New Zealand
Phone 9581 0
+64 3 4740999 (Ext. 8785)
Fax 9581 0
+64 3 4776246
Email 9581 0
richard.hewitt@stonebow.otago.ac.nz
Contact person for scientific queries
Name 509 0
Professor D Robin Taylor
Address 509 0
Otago Respiratory Research Unit
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin
Country 509 0
New Zealand
Phone 509 0
+64 3 4740999 (Ext. 8785)
Fax 509 0
+64 3 4776246
Email 509 0
robin.taylor@stonebow.otago.ac.nz

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.