The Effect Of AVANDIA On The Late Asthmatic Response

NCT00318630 | Completed Phase 1

• 1 other identifier: 104385
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

Asthma AVANDIA Inflammation

Outcome Measures

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.

  Up to 43 days

Secondary Outcomes (1)

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

  Up to 43 days

Study Arms (2)

Subjects receiving treatment 1

EXPERIMENTAL

Eligible subjects will receive rosiglitazone immediate release tablet with a dose of 4 milligrams twice daily administered orally for 28 days followed by placebo oral tablet.

Drug: Rosiglitazone; Drug: Placebo

Subjects receiving treatment 2

EXPERIMENTAL

Eligible subjects will receive placebo oral tablet followed by rosiglitazone immediate release tablet with a dose of 4 milligrams twice daily for 28 days.

Drug: Rosiglitazone; Drug: Placebo

Interventions

Rosiglitazone DRUG

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

Subjects receiving treatment 1; Subjects receiving treatment 2

Placebo DRUG

Subjects will also receive placebo oral tablet.

Subjects receiving treatment 1; Subjects receiving treatment 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Mild asthmatic treated with short-acting beta agonists only, non-smoker.

You may not qualify if:

• Inability to abstain from medications other than short-acting beta agonists and paracetamol.
• Recent administration of steroids.
• Recent respiratory infection or exacerbation of asthma.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Wellington, 6035, New Zealand

Location

Related Publications (2)

• This study has not been published in the scientific literature.

  BACKGROUND

• Richards DB, Bareille P, Lindo EL, Quinn D, Farrow SN. Treatment with a peroxisomal proliferator activated receptor gamma agonist has a modest effect in the allergen challenge model in asthma: a randomised controlled trial. Respir Med. 2010 May;104(5):668-74. doi: 10.1016/j.rmed.2009.11.006. Epub 2009 Nov 26.

  PMID: 19944580 DERIVED

Related Links

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

MeSH Terms

Conditions

Asthma

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2006
• First Posted: April 27, 2006
• Study Start: July 22, 2005
• Primary Completion: June 30, 2006
• Study Completion: June 30, 2006
• Last Updated: September 25, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share

Locations

NZ (1)