The Use of Rosiglitazone to Treat Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tammy Wichman, Creighton University
ClinicalTrials.gov Identifier:
NCT00614874
First received: January 31, 2008
Last updated: September 1, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: rosiglitazone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of the PPARy Agonist Rosiglitazone on Airway Hyperreactivity

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Methacholine Responsiveness as Assessed by PC20, [ Time Frame: patients were assessed at baseline and at 12 weeks ] [ Designated as safety issue: No ]
    PC20 is the concentration of methacholine at which patients had a decrease in Forced Expiratory Volume in one second (FEV1) of 20%


Secondary Outcome Measures:
  • Exhaled Nitric Oxide in Parts Per Billion (Ppb), Parts Per Billion [ Time Frame: patients were assessed at baseline and 12 weeks ] [ Designated as safety issue: No ]
    Fraction Exhaled Nitric oxide was measured on each visit prior to bronchoprovocation by chemiluminescence using an analyzer.

  • Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: patients were assessed at baseline and 12 weeks ] [ Designated as safety issue: No ]
    FEV1 in liters

  • Forced Expiratory Volume in One Second (FEV1) Percent Predicted [ Time Frame: patients were assessed at baseline and 12 weeks ] [ Designated as safety issue: No ]
    Spirometry was performed on each visit according to American Thoracic Society guidelines. FEV1 percent predicted was measured.


Enrollment: 16
Study Start Date: December 2008
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614874

Locations
United States, Nebraska
Creighton University Medical Center, Department of Pulmonology and Critical Care
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Tammy Wichman, MD Creighton University Medical Center
  More Information

Publications:

Responsible Party: Tammy Wichman, Associate Professor of Medicine, Creighton University
ClinicalTrials.gov Identifier: NCT00614874     History of Changes
Other Study ID Numbers: 07-14592
Study First Received: January 31, 2008
Results First Received: June 17, 2011
Last Updated: September 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
Asthma
Avandia

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

ClinicalTrials.gov processed this record on October 29, 2014