Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000353695
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
Tolerance 3
Scientific title
The effects of repeated bronchoconstriction on response to "reliever" medication in asthma.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 447 0
Condition category
Condition code
Respiratory 524 524 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised, placebo-controlled, cross-over investigation. There will be two phases during which beta agonist will or will not be given on a regular basis. Each phase will last a month, with a 1-2 week washout period inbetween. At each visit, 2 bronchial challenges will be administered and either placebo, anti-cholinergic or beta-agonist relief will be given.
Intervention code [1] 393 0
None
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 599 0
To confirm that the recovery to normal lung function, within 15 minutes, is impaired to a greater extent following repeated bronchoconstriction
Timepoint [1] 599 0
Primary outcome [2] 600 0
To distinguish if any impairment is specific for beta-agonist or also occurs with anti-cholinergic medication
Timepoint [2] 600 0
Primary outcome [3] 601 0
To assess if any of these effects are modified by regular bronchodilator
Timepoint [3] 601 0
Secondary outcome [1] 1264 0
None
Timepoint [1] 1264 0

Eligibility
Key inclusion criteria
Asthma (according to the ATS), Non-smokers.
Minimum age
12 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, high dose ICS, history of life-threatening asthma, unable to tolerate ipratropium as a reliever inhaler, recent use of oral steroids, LRTI.

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)
The inhalers were blinded and labelled by a party not recording response and dispensed by the same party according to the randomisation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was by Latin Sqaure.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 180 0
New Zealand
State/province [1] 180 0

Funding & Sponsors
Funding source category [1] 583 0
Charities/Societies/Foundations
Name [1] 583 0
Otago Medical Research Foundation
Country [1] 583 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Otago Medical Research Foundation
Address
Country
New Zealand
Secondary sponsor category [1] 472 0
Individual
Name [1] 472 0
Professor Robin Taylor
Address [1] 472 0
Dunedin School of Medicine
Country [1] 472 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35504 0
Address 35504 0
Country 35504 0
Phone 35504 0
Fax 35504 0
Email 35504 0
Contact person for public queries
Name 9582 0
Dr Tim Sutherland
Address 9582 0
Respiratory Research Unit
Department of Medical and Surgical Sciences
Dunedin Hospital
PO Box 913
Dunedin
Country 9582 0
New Zealand
Phone 9582 0
+64 3 4740999 (Ext. 8785)
Fax 9582 0
Email 9582 0
[email protected]
Contact person for scientific queries
Name 510 0
Professor Robin Taylor
Address 510 0
Respiratory Research Unit
Department of Medical and Surgical Sciences
Dunedin Hospital
PO Box 913
Dunedin
Country 510 0
New Zealand
Phone 510 0
+64 3 4740999 (Ext. 8785)
Fax 510 0
Email 510 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.