The Effect Of AVANDIA On The Late Asthmatic Response

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00318630

Enrollment

Registered

2006-04-27

Start date

2005-07-22

Completion date

2006-06-30

Last updated

2017-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma AVANDIA Inflammation

Brief summary

This study is to investigate the effects of AVANDIA on the asthmatic response.

Interventions

DRUGRosiglitazone

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

DRUGPlacebo

Subjects will also receive placebo oral tablet.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* Mild asthmatic treated with short-acting beta agonists only, non-smoker.

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.

Design outcomes

Primary

Measure	Time frame
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.	Up to 43 days

Secondary

Measure	Time frame
The early asthmatic response to allergen, bronchial challenge, nitric oxide, markers of inflammation and safety/tolerability.	Up to 43 days

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026