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The Use of Rosiglitazone to Treat Asthma

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

rosiglitazone

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Avandia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Creighton University Medical Center, Department of Pulmonology and Critical Care

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Subjects took rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks

Outcomes

Primary Outcome Measures

Methacholine Responsiveness as Assessed by PC20,

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

Fraction Exhaled Nitric oxide was measured on each visit prior to bronchoprovocation by chemiluminescence using an analyzer.

Forced Expiratory Volume in 1 Second (FEV1)

FEV1 in liters

Forced Expiratory Volume in One Second (FEV1) Percent Predicted

Spirometry was performed on each visit according to American Thoracic Society guidelines. FEV1 percent predicted was measured.

Full Information

NCT ID

NCT00614874

First Posted

January 31, 2008

Last Updated

September 1, 2011

Sponsor

Creighton University

1. Study Identification

Unique Protocol Identification Number

NCT00614874

Brief Title

The Use of Rosiglitazone to Treat Asthma

Official Title

The Effects of the PPARy Agonist Rosiglitazone on Airway Hyperreactivity

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Creighton University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, Avandia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Subjects took rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks

Intervention Type

Drug

Intervention Name(s)

rosiglitazone

Intervention Description

2mg, 4mg, 8mg

Primary Outcome Measure Information:

Title

Methacholine Responsiveness as Assessed by PC20,

Description

PC20 is the concentration of methacholine at which patients had a decrease in Forced Expiratory Volume in one second (FEV1) of 20%

Time Frame

patients were assessed at baseline and at 12 weeks

Secondary Outcome Measure Information:

Title

Exhaled Nitric Oxide in Parts Per Billion (Ppb), Parts Per Billion

Description

Fraction Exhaled Nitric oxide was measured on each visit prior to bronchoprovocation by chemiluminescence using an analyzer.

Time Frame

patients were assessed at baseline and 12 weeks

Title

Forced Expiratory Volume in 1 Second (FEV1)

Description

FEV1 in liters

Time Frame

patients were assessed at baseline and 12 weeks

Title

Forced Expiratory Volume in One Second (FEV1) Percent Predicted

Description

Spirometry was performed on each visit according to American Thoracic Society guidelines. FEV1 percent predicted was measured.

Time Frame

patients were assessed at baseline and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tammy Wichman, MD

Organizational Affiliation

Creighton University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Creighton University Medical Center, Department of Pulmonology and Critical Care

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

10195695

Citation

Matsuura H, Adachi H, Smart RC, Xu X, Arata J, Jetten AM. Correlation between expression of peroxisome proliferator-activated receptor beta and squamous differentiation in epidermal and tracheobronchial epithelial cells. Mol Cell Endocrinol. 1999 Jan 25;147(1-2):85-92. doi: 10.1016/s0303-7207(98)00214-7.

Results Reference

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PubMed Identifier

11704601

Citation

Benayoun L, Letuve S, Druilhe A, Boczkowski J, Dombret MC, Mechighel P, Megret J, Leseche G, Aubier M, Pretolani M. Regulation of peroxisome proliferator-activated receptor gamma expression in human asthmatic airways: relationship with proliferation, apoptosis, and airway remodeling. Am J Respir Crit Care Med. 2001 Oct 15;164(8 Pt 1):1487-94. doi: 10.1164/ajrccm.164.8.2101070.

Results Reference

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PubMed Identifier

12900517

Citation

Woerly G, Honda K, Loyens M, Papin JP, Auwerx J, Staels B, Capron M, Dombrowicz D. Peroxisome proliferator-activated receptors alpha and gamma down-regulate allergic inflammation and eosinophil activation. J Exp Med. 2003 Aug 4;198(3):411-21. doi: 10.1084/jem.20021384.

Results Reference

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PubMed Identifier

16815147

Citation

Lee KS, Kim SR, Park SJ, Park HS, Min KH, Jin SM, Lee MK, Kim UH, Lee YC. Peroxisome proliferator activated receptor-gamma modulates reactive oxygen species generation and activation of nuclear factor-kappaB and hypoxia-inducible factor 1alpha in allergic airway disease of mice. J Allergy Clin Immunol. 2006 Jul;118(1):120-7. doi: 10.1016/j.jaci.2006.03.021. Epub 2006 May 19.

Results Reference

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PubMed Identifier

14695339

Citation

Hammad H, de Heer HJ, Soullie T, Angeli V, Trottein F, Hoogsteden HC, Lambrecht BN. Activation of peroxisome proliferator-activated receptor-gamma in dendritic cells inhibits the development of eosinophilic airway inflammation in a mouse model of asthma. Am J Pathol. 2004 Jan;164(1):263-71. doi: 10.1016/s0002-9440(10)63116-1.

Results Reference

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PubMed Identifier

16150927

Citation

Kim SR, Lee KS, Park HS, Park SJ, Min KH, Jin SM, Lee YC. Involvement of IL-10 in peroxisome proliferator-activated receptor gamma-mediated anti-inflammatory response in asthma. Mol Pharmacol. 2005 Dec;68(6):1568-75. doi: 10.1124/mol.105.017160. Epub 2005 Sep 8.

Results Reference

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PubMed Identifier

15131570

Citation

Honda K, Marquillies P, Capron M, Dombrowicz D. Peroxisome proliferator-activated receptor gamma is expressed in airways and inhibits features of airway remodeling in a mouse asthma model. J Allergy Clin Immunol. 2004 May;113(5):882-8. doi: 10.1016/j.jaci.2004.02.036.

Results Reference

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PubMed Identifier

14718259

Citation

Ward JE, Gould H, Harris T, Bonacci JV, Stewart AG. PPAR gamma ligands, 15-deoxy-delta12,14-prostaglandin J2 and rosiglitazone regulate human cultured airway smooth muscle proliferation through different mechanisms. Br J Pharmacol. 2004 Feb;141(3):517-25. doi: 10.1038/sj.bjp.0705630. Epub 2004 Jan 12.

Results Reference

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PubMed Identifier

11415933

Citation

Wang AC, Dai X, Luu B, Conrad DJ. Peroxisome proliferator-activated receptor-gamma regulates airway epithelial cell activation. Am J Respir Cell Mol Biol. 2001 Jun;24(6):688-93. doi: 10.1165/ajrcmb.24.6.4376.

Results Reference

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PubMed Identifier

11815521

Citation

Hashimoto Y, Nakahara K. Improvement of asthma after administration of pioglitazone. Diabetes Care. 2002 Feb;25(2):401. doi: 10.2337/diacare.25.2.401. No abstract available.

Results Reference

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PubMed Identifier

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Citation

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Citation

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Results Reference

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The Use of Rosiglitazone to Treat Asthma

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