The Effect Of AVANDIA On The Late Asthmatic Response

This study has been completed.

First Received: April 25, 2006 Last Updated: 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:	Treatment, Randomized, Double-Blind, Crossover Assignment, Pharmacodynamics Study
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

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

Eligibility

Criteria

Inclusion 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.

Contacts and Locations

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

Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

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

Keywords provided by GlaxoSmithKline:

Asthma AVANDIA Inflammation

Additional relevant MeSH terms:

Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Asthma
Pharmacologic Actions
Lung Diseases, Obstructive
Hypersensitivity

Hypoglycemic Agents
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Rosiglitazone
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010