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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
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

Study type
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

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

Key inclusion criteria
Inclusion criteria:

- Mild asthmatic treated with short-acting beta agonists only, non-smoker.
Minimum age
18 Years
Maximum age
55 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Exclusion criteria:

- Inability to abstain from medications other than short-acting beta agonists and

- Recent administration of steroids.

- Recent respiratory infection or exacerbation of asthma.

Study design
Purpose of the study
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
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry

Ethics approval
Ethics application status

Brief summary
This study is to investigate the effects of AVANDIA on the asthmatic response.
Trial website
Trial related presentations / publications
This study has not been published in the scientific literature.
Public notes

Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
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

Summary results
Other publications