The Effect Of AVANDIA On The Late Asthmatic Response

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-22

Study Completion Date

2006-06-30

Brief Summary

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

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Study Groups

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Subjects receiving treatment 1

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.

Group Type EXPERIMENTAL

Rosiglitazone

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Subjects will also receive placebo oral tablet.

Subjects receiving treatment 2

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

Group Type EXPERIMENTAL

Rosiglitazone

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Subjects will also receive placebo oral tablet.

Interventions

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Rosiglitazone

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

Intervention Type DRUG

Placebo

Subjects will also receive placebo oral tablet.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Wellington, , New Zealand

Site Status

Countries

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New Zealand

References

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This study has not been published in the scientific literature.

Reference Type 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.

Reference Type DERIVED

PMID: 19944580 (View on PubMed)

Study Documents

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