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OpenTrials
Completed

NCT Number: NCT00318630

The Effect Of AVANDIA On The Late Asthmatic Response

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

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Wellington, 6035, New Zealand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rosiglitazone

Drug

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

Placebo

Drug

Subjects will also receive placebo oral tablet.

Primary outcomes

  1. 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.

    Time frame: Up to 43 days

Secondary outcomes

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

    Time frame: Up to 43 days

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Apr 27, 2006
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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