The Use of Rosiglitazone to Treat Asthma

September 1, 2011 updated by: Tammy Wichman, Creighton University

The Effects of the PPARy Agonist Rosiglitazone on Airway Hyperreactivity

Asthma is a common chronic disease characterized by airway inflammation and bronchoconstriction. This study utilizes the drug rosiglitazone (Avandia)to treat the effects of airway inflammation in patients with asthma.

The study will be conducted on 14 adult steroid naive patients with asthma. Patients with qualifying pulmonary function testing values will be eligible for enrollment. Enrolled subjects will be treated with rosiglitazone orally at 2mg dose for 4 weeks. Patients will be reassessed and dosing will increase in 4 week increments up to 8mg.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The current standard-of-care utilizes corticosteroids to down-regulate the inflammatory state in patients with asthma. However, corticosteroids have many side effects and are not universally effective. New safe anti-inflammatory agents are needed to help modulate the disease. Peroxisome proliferator-activated receptor agonists are widely used to manage diabetes mellitus, another common chronic disease. These agents have been study models and have been shown to have anti-inflammatory effects in lung tissue. Case reports have noted improvement in asthma symptoms in patients being treated with these agents. These agents are ideally placed for human research given their long record of safe use in the treatment of type 2 diabetes.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University Medical Center, Department of Pulmonology and Critical Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to comprehend and grant a witnessed, written informed consent
  • Must be greater than 19 years old
  • Must be able to swallow a tablet
  • Female participants must have a negative urine pregnancy test at visit 1 and throughout duration of the study
  • Must have a history of physician diagnosed asthma
  • Must have a baseline FEV1 >60% predicted
  • Must be able to perform pulmonary function testing
  • Must have methacholine-induced decrease in FEV1 of 20%
  • Must be capable of withholding medications that may affect the methacholine challenge test
  • Must be able to withstand a 30 day washout period for all inhaled corticosteroids
  • Must be able to attend all office visits, 4 weeks apart for 12 weeks. Each visit will last approximately 2-3 hours

Exclusion Criteria:

  • Age 18 or younger
  • FEV1 <60% predicted value
  • History or presence of significant renal, hepatic,neurologic, cardiovascular, hematologic, cerebrovascular, respiratory, endocrine, gastrointestinal, or collagen vascular disorder that in the Investigator's opinion could interfere with the study or require medical attention that would interfere with the study.
  • History of cancer other than basal cell skin cancer
  • History of hypoglycemia
  • Current smokers, greater than 10 pack year history, or patients quitting less than 1 year prior to screening
  • History within the past year of excessive alcohol intake or drug addiction
  • History of respiratory infection requiring treatment with an antibiotic within 2 week prior to visit 1
  • Chronic intermittent use of inhaled, oral, intra-muscular, topical or intravenous corticosteroids within 4 weeks of visit 1
  • Inability to perform consistent spirometry or nitric oxide exhalation
  • Treatment with an experimental, non-approved drug, or investigational drug within the past 30 days
  • Known hypersensitivity to rosiglitazone
  • History of noncompliance to medical regimens and participants who are considered to be potentially unreliable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Subjects took rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
Drug: rosiglitazone
2mg, 4mg, 8mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Methacholine Responsiveness as Assessed by PC20,
Time Frame: patients were assessed at baseline and at 12 weeks
PC20 is the concentration of methacholine at which patients had a decrease in Forced Expiratory Volume in one second (FEV1) of 20%
patients were assessed at baseline and at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exhaled Nitric Oxide in Parts Per Billion (Ppb), Parts Per Billion
Time Frame: patients were assessed at baseline and 12 weeks
Fraction Exhaled Nitric oxide was measured on each visit prior to bronchoprovocation by chemiluminescence using an analyzer.
patients were assessed at baseline and 12 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: patients were assessed at baseline and 12 weeks
FEV1 in liters
patients were assessed at baseline and 12 weeks
Forced Expiratory Volume in One Second (FEV1) Percent Predicted
Time Frame: patients were assessed at baseline and 12 weeks
Spirometry was performed on each visit according to American Thoracic Society guidelines. FEV1 percent predicted was measured.
patients were assessed at baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Investigators

  • Principal Investigator: Tammy Wichman, MD, Creighton University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

January 31, 2008

First Submitted That Met QC Criteria

February 12, 2008

First Posted (Estimate)

February 13, 2008

Study Record Updates

Last Update Posted (Estimate)

September 2, 2011

Last Update Submitted That Met QC Criteria

September 1, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-14592

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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