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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00787644
Recruitment Status : Terminated (new safety concerns which emerged about pioglitazone during the trial)
First Posted : November 7, 2008
Results First Posted : February 26, 2015
Last Update Posted : February 26, 2015
American Lung Association
University of Pittsburgh
Information provided by (Responsible Party):
Anne Dixon, University of Vermont

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.

Condition or disease Intervention/treatment Phase
Asthma Obesity Drug: Pioglitazone Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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. (The GLITZ Asthma Study)
Study Start Date : January 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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)

Placebo Comparator: 2 Drug: Placebo
Matching placebo (inert tablet)

Primary Outcome Measures :
  1. PC20 [ Time Frame: 12 weeks ]

    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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00787644

United States, Vermont
The Vermont Lung Center at the University of Vermont
Colchester, Vermont, United States, 05446
Sponsors and Collaborators
University of Vermont
American Lung Association
University of Pittsburgh
Principal Investigator: Anne E Dixon, MD The Vermont Lung Center at the University of Vermont

Additional Information:
Responsible Party: Anne Dixon, M.D., University of Vermont Identifier: NCT00787644     History of Changes
Other Study ID Numbers: GLITZ Asthma
First Posted: November 7, 2008    Key Record Dates
Results First Posted: February 26, 2015
Last Update Posted: February 26, 2015
Last Verified: February 2015

Keywords provided by Anne Dixon, University of Vermont:
Adipose Tissue

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs