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

Obesity Clinical Trial

— GLITZ  

Official title:

A Randomized, Placebo-Controlled Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics. (The GLITZ Asthma Study)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00787644
• Other study ID #: GLITZ Asthma
• Status: Terminated
• Phase: Phase 2
• First received: November 5, 2008
• Last updated: February 25, 2015
• Start date: January 2009
• Est. completion date: December 2013

Study information

• Verified date: February 2015
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Obesity

Intervention

Drug:
• Pioglitazone
Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
• Placebo
Matching placebo (inert tablet)

Locations

Country	Name	City	State
United States	The Vermont Lung Center at the University of Vermont	Colchester	Vermont

Sponsors (3)

Lead Sponsor	Collaborator
University of Vermont	American Lung Association, University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hashimoto Y, Nakahara K. Improvement of asthma after administration of pioglitazone. Diabetes Care. 2002 Feb;25(2):401. — View 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. Epub 2006 May 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   Asthma informational website
•   Asthma informational website