Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics - Full Text View

Sponsor:	University of Pittsburgh
Collaborators:	Takeda Global Research & Development Center, Inc. University of Vermont
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00634036

Purpose

Asthmatics who are significantly overweight tend to have more severe symptoms, more flare ups, and are more likely to have poorly-controlled asthma when compared to other asthmatics.

Researchers believe this occurs because excess adipose tissue (fat) in the body can cause higher-than-normal levels of leptin and lower-than-normal levels of adiponectin in the blood.

The researchers of this study are testing a medication called pioglitazone in overweight asthmatics because they believe it can help regulate leptin and adiponectin and that this may improve symptoms of asthma.

Condition	Intervention	Phase
Asthma	Drug: pioglitazone Drug: placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Placebo-Controlled Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics

Resource links provided by NLM:

MedlinePlus related topics: Asthma Obesity

Drug Information available for: Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Airway reactivity will be measured with methacholine challenge testing following ATS guidelines [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pulmonary function as measured by FEV1 and FVC following ATS guidelines [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Asthma symptoms and control will be objectively monitored using the Juniper Questionnaire, Asthma Quality of Life Questionnaire, and St. George Respiratory Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	October 2009
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Drug: pioglitazone pioglitazone tablets: 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months) Other Name: Actos
Placebo Comparator: 2	Drug: placebo matching placebo (inert tablet)

Detailed Description:

Participants in this study will be randomly assigned (like the flip of a coin) to pioglitazone or a placebo (an inactive pill). They will be given study medication to take everyday for 12 weeks (3 months).

Participants will complete a number of asthma-related questionnaires and a variety of pulmonary function tests. Participants will undergo physical exams, an electrocardiogram, and blood sampling to measure leptin, adiponectin, markers of inflammation, blood cell counts, glucose levels, BNP hormone levels, and liver function.

To monitor participants throughout the study, follow-up visits will be done at 2, 6, and 12 weeks after starting study drug. At these visits many of the pulmonary function tests and questionnaires will be repeated.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Asthma diagnosed by a physician at least 1 year prior to study enrollment
Poorly-controlled asthma at study enrollment
Non smokers (stopped smoking at least 1 year ago) and limited life-time history of smoking
Body mass index 30-60
Responds to methacholine challenge test with PC20 of <16 mg/ml
On a stable dose of inhaled corticosteroid for at least 4 weeks prior to study entry
FEV1 >60% predicted
Able to obtain weekly weights at home

Exclusion Criteria:

Systemic steroids within the past 4 weeks
Lung pathology other than asthma
Other significant non-pulmonary co-morbidities such as: coronary artery disease, peripheral vascular disease, cerebrovascular disease, congestive heart failure with an ejection fraction <50%, liver disease or elevated liver enzymes at baseline, malignancy (excluding non-melanoma skin cancers), AIDS, renal failure with serum creatinine >3.0, or disorders requiring steroid treatment such as vasculitis, lupus, rheumatoid arthritis
B-type natriuretic peptide (BNP) >400 pg/mL
Pregnant or lactating
Currently taking a beta blocker, a CYP2C8 inhibitor or inducer such as gemfibrozil or rifampin, a TZD (thiazolidinedione), or allergic to TZD
Taking antioxidants or nutritional supplements (stable dose of calcium, vitamin D, or multivitamin is OK)
Illicit drug use within the past year
Current/active upper respiratory infection (if active URI, wait until asymptomatic for 1 week to enroll)
Asthma exacerbation within the past 4 weeks (includes ER, urgent care, or hospital visits due to asthma resulting in an increase in asthma-related medications)
Undergoing evaluation for sleep apnea, or plans to institute treatment for sleep apnea (patients on a stable treatment regimen for sleep apnea for the last 3 months will be allowed to participate)
Clinically significant abnormalities present on screening 12-lead electrocardiogram
Women of childbearing potential using oral contraceptives who are not willing to use a second method of contraception during the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634036

Locations

United States, Pennsylvania
University of Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Laila Moore 412-647-9955 asthmainstitute@upmc.edu
Contact: Fernando Holguin, MD, MPH 412-692-2139 holguinf@upmc.edu
United States, Vermont
University of Vermont	Recruiting
Colchester, Vermont, United States, 05446
Contact: Laurianne Griffes, 802-847-3627 Laurianne.Griffes@vtmednet.org

Sponsors and Collaborators

University of Pittsburgh

Takeda Global Research & Development Center, Inc.

University of Vermont

Investigators

Principal Investigator:	Fernando Holguin, MD, MPH	University of Pittsburgh
Principal Investigator:	Anne E. Dixon, MD	University of Vermont

More Information

Additional Information:

Asthma informational website This link exits the ClinicalTrials.gov site

Publications:

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

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.

Responsible Party:	Fernando Holguin, MD, MPH, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00634036 History of Changes
Other Study ID Numbers:	GLITZ 001, 00001949
Study First Received:	March 5, 2008
Last Updated:	January 10, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:

Asthma
obesity
exacerbation
asthmatics
fat
overweight
adipose tissue
leptin

adiponectin
pioglitazone
Actos
wheezing
Pittsburgh
Pennsylvania
pulmonary
lung

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate

Hypersensitivity
Immune System Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2012