The Effect Of AVANDIA On The Late Asthmatic Response
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Avandia (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
This study is to investigate the effects of AVANDIA on the asthmatic response.
Clinical Details
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.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study
Primary outcome: 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: The early asthmatic response to allergen, bronchial challenge, nitric oxide, markers of inflammation and safety/tolerability.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
GSK Clinical Trials Call Center, Wellington 6004, New Zealand
Additional Information
Starting date: May 2005
Last updated: April 20, 2007
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