The Effect Of AVANDIA On The Late Asthmatic Response

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318630
• Other study ID #: 104385
• Status: Completed
• Phase: Phase 1
• First received: April 25, 2006
• Last updated: September 21, 2017
• Start date: July 22, 2005
• Est. completion date: June 30, 2006

Study information

• Verified date: September 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 30, 2006
• Est. primary completion date: June 30, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Rosiglitazone
Rosiglitazone will be given as immediate release tablet of 4 milligrams administered orally for 28 days.
• Placebo
Subjects will also receive placebo oral tablet.

Locations

Country	Name	City	State
New Zealand	GSK Investigational Site	Wellington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

New Zealand, 

References & Publications (1)

This study has not been published in the scientific literature.

Outcome

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

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study 104385 can be found on the GSK Clinical Study Register.