The Effect Of AVANDIA On The Late Asthmatic Response

This study has been completed.

First Received on April 25, 2006. Last Updated on December 10, 2009 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00318630

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: Avandia	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

The early asthmatic response to allergen, bronchial challenge, nitric oxide, markers of inflammation and safety/tolerability.

Estimated Enrollment:	34
Study Start Date:	July 2005

Intervention Details:

Other Name: Avandia

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318630

Locations

New Zealand
GSK Investigational Site
Wellington, New Zealand, 6035

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00318630 History of Changes
Other Study ID Numbers:	104385
Study First Received:	April 25, 2006
Last Updated:	December 10, 2009
Health Authority:	New Zealand: Medsafe

Keywords provided by GlaxoSmithKline:

Asthma AVANDIA Inflammation

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate

Hypersensitivity
Immune System Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012