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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
Date last updated
25/09/2017

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
This study is to investigate the effects of AVANDIA on the asthmatic response.
Trial website
https://clinicaltrials.gov/study/NCT00318630
Trial related presentations / publications
This study has not been published in the scientific literature.
Richards DB, Bareille P, Lindo EL, Quinn D, Farrow SN. Treatment with a peroxisomal proliferator activated receptor gamma agonist has a modest effect in the allergen challenge model in asthma: a randomised controlled trial. Respir Med. 2010 May;104(5):668-74. doi: 10.1016/j.rmed.2009.11.006. Epub 2009 Nov 26.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00318630