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

NCT00787644 | Terminated Phase 2 Results DMC

• 1 other identifier: GLITZ Asthma
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Obesity

Keywords

Asthma; Adipose Tissue; Asthmatics; Pioglitazone; Actos; Obesity; Exacerbation; Fat; Overweight; Leptin; Adiponectin; Wheezing; Vermont; Pulmonary; Lung

Outcome Measures

Primary Outcomes (1)

• PC20

  Airway reactivity will be measured with methacholine challenge testing following ATS guidelines. This is the concentration of methacholine that produces a 20% decrease in lung function (measured by forced expiratory volume in 1 second)

  12 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Pioglitazone

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pioglitazone DRUG

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

1

Placebo DRUG

Matching placebo (inert tablet)

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead
• American Lung Association: collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

The Vermont Lung Center at the University of Vermont

Colchester, Vermont, 05446, United States

Location

Related Publications (2)

• 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.

  PMID: 11815521 BACKGROUND

• 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.

  PMID: 16815147 BACKGROUND

Related Links

• Asthma informational website
• Asthma informational website

MeSH Terms

Conditions

Asthma; Obesity; Platelet Glycoprotein IV Deficiency; Overweight; Respiratory Sounds

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Dr. Anne Dixon
• Organization: University of Vermont

anne.dixon@uvm.edu

802 656 3525

Study Officials

• Anne E Dixon, MD

  The Vermont Lung Center at the University of Vermont

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: November 5, 2008
• First Posted: November 7, 2008
• Study Start: January 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 26, 2015
• Results First Posted: February 26, 2015

Record last verified: 2015-02

Locations

US (1)