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The Effect Of AVANDIA On The Late Asthmatic Response

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ClinicalTrials.gov Identifier: NCT00318630
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

Condition or disease Intervention/treatment Phase
Asthma Drug: Rosiglitazone Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
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
Actual Study Start Date : July 22, 2005
Primary Completion Date : June 30, 2006
Study Completion Date : June 30, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

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



Primary Outcome Measures :
  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 Outcome Measures :
  1. The early asthmatic response to allergen, bronchial challenge, nitric oxide, markers of inflammation and safety/tolerability. [ Time Frame: Up to 43 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00318630


Locations
New Zealand
GSK Investigational Site
Wellington, New Zealand, 6035
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Publications:
This study has not been published in the scientific literature.

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 104385
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 104385
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 104385
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 104385
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 104385
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 104385
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 104385
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00318630     History of Changes
Other Study ID Numbers: 104385
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://

Keywords provided by GlaxoSmithKline:
Asthma AVANDIA Inflammation

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs