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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00318630




Registration number
NCT00318630
Ethics application status
Date submitted
25/04/2006
Date registered
27/04/2006

Titles & IDs
Public title
The Effect Of AVANDIA On The Late Asthmatic Response
Scientific title
A Randomised Double-blind Two-period Crossover Study to Investigate the Effect of Treatment With Repeat Doses of a PPAR Gamma Agonist on the Allergen-induced Late Asthmatic Response in Subjects With Mild Asthma Compared With Repeat Doses of Placebo
Secondary ID [1] 0 0
104385
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rosiglitazone
Treatment: Drugs - Placebo

Experimental: Subjects receiving treatment 1 - Eligible subjects will receive rosiglitazone immediate release tablet with a dose of 4 milligrams twice daily administered orally for 28 days followed by placebo oral tablet.

Experimental: Subjects receiving treatment 2 - Eligible subjects will receive placebo oral tablet followed by rosiglitazone immediate release tablet with a dose of 4 milligrams twice daily for 28 days.


Treatment: Drugs: Rosiglitazone
Rosiglitazone will be given as immediate release tablet of 4 milligrams administered orally for 28 days.

Treatment: Drugs: Placebo
Subjects will also receive placebo oral tablet.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The effect of repeat oral doses of AVANDIA for 28 days on the late asthmatic response to inhaled allergen. Measured as lung function 4-10 hours after allergen challenge after 28 days dosing.
Timepoint [1] 0 0
Up to 43 days
Secondary outcome [1] 0 0
The early asthmatic response to allergen, bronchial challenge, nitric oxide, markers of inflammation and safety/tolerability.
Timepoint [1] 0 0
Up to 43 days

Eligibility
Key inclusion criteria
Inclusion criteria:

* Mild asthmatic treated with short-acting beta agonists only, non-smoker.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Inability to abstain from medications other than short-acting beta agonists and paracetamol.
* Recent administration of steroids.
* Recent respiratory infection or exacerbation of asthma.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/07/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2006
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00318630