Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics (Glitz Asthma)

NCT ID: NCT00787644

Last Updated: 2015-02-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2013-12-31

Brief Summary

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 bosy can cause higher-than-normal levels of leptin and lower 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.

Detailed Description

Participants in this study will be randomly assigned (like the flip of a coin) to pioglitazone or placebo (an inactive pill). They will be given study medication to take every day 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.

Conditions

Asthma; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

Pioglitazone

Intervention Type: DRUG

Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)

2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo (inert tablet)

Interventions

Pioglitazone

Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)

Intervention Type: DRUG

Placebo

Matching placebo (inert tablet)

Intervention Type: DRUG

Eligibility 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 lifetime 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) >400pg/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 (if taking a multivitamin must be on a stable regimen prior to enrollment)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Lung Association

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Anne Dixon

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne E Dixon, MD

Role: PRINCIPAL_INVESTIGATOR

The Vermont Lung Center at the University of Vermont

Locations

The Vermont Lung Center at the University of Vermont

Colchester, Vermont, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 11815521 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16815147 (View on PubMed)

Related Links

http://www.nhlbi.nih.gov/health/dci/Diseases/Asthma/Asthma_WhatIs.html

Asthma informational website

http://www.ginasthma.com/

Asthma informational website

Other Identifiers

GLITZ Asthma

Identifier Type: -

Identifier Source: org_study_id