The Use of Rosiglitazone to Treat Asthma

This study has been completed.

Study NCT00614874 Information provided by Creighton University

First Received on January 31, 2008. Last Updated on September 1, 2011 History of Changes

Results First Received: June 17, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Asthma
Intervention:	Drug: rosiglitazone

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was through pulmonary and allergy/immunology clinics from September 2008 to November 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
32 patients assessed for eligibility. 16 did not meet inclusion criteria. None of the 16 participants allocated to treatment were excluded before the study began.

Reporting Groups

	Description
Rosiglitazone	Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks

Participant Flow: Overall Study

	Rosiglitazone
STARTED	16
COMPLETED	14
NOT COMPLETED	2
Protocol Violation	1
Withdrawal by Subject	1

Baseline Characteristics

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Reporting Groups

	Description
Rosiglitazone	Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks

Baseline Measures

	Rosiglitazone
Number of Participants [units: participants]	16
Age [units: participants]
<=18 years	0
Between 18 and 65 years	16
>=65 years	0
Age [units: years] Mean ± Standard Deviation	34 ± 24
Gender [units: participants]
Female	10
Male	6
Region of Enrollment [units: participants]
United States	16

Outcome Measures

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1. Primary:

Methacholine Responsiveness as Assessed by PC20, [ Time Frame: patients were assessed at baseline and at 12 weeks ]

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2. Secondary:

Exhaled Nitric Oxide in Parts Per Billion (Ppb), Parts Per Billion [ Time Frame: patients were assessed at baseline and 12 weeks ]

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3. Secondary:

Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: patients were assessed at baseline and 12 weeks ]

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4. Secondary:

Forced Expiratory Volume in One Second (FEV1) Percent Predicted [ Time Frame: patients were assessed at baseline and 12 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size. Lack of placebo control arm.

Results Point of Contact:

Name/Title: Dr. Tammy Wichman
Organization: Creighton University School of Medicine
phone: 402-449-4486
e-mail: wichman@creighton.edu

Publications:

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.

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.

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.

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. Epub 2006 May 19.

Hammad H, de Heer HJ, Soullié 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.

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. Epub 2005 Sep 8.

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.

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. Epub 2004 Jan 12.

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.

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

Kharitonov SA, Gonio F, Kelly C, Meah S, Barnes PJ. Reproducibility of exhaled nitric oxide measurements in healthy and asthmatic adults and children. Eur Respir J. 2003 Mar;21(3):433-8.

Eder W, Ege MJ, von Mutius E. The asthma epidemic. N Engl J Med. 2006 Nov 23;355(21):2226-35. Review. No abstract available.

Responsible Party:	Tammy Wichman, 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