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

This study has been completed.
University of Vermont
Information provided by (Responsible Party):
Fernando Holguin, University of Pittsburgh Identifier:
First received: March 5, 2008
Last updated: January 8, 2016
Last verified: January 2016

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
Drug: pioglitazone
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

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 ]

Secondary Outcome Measures:
  • Pulmonary function as measured by FEV1 and FVC following ATS guidelines [ Time Frame: 12 weeks ]
  • 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 ]

Enrollment: 19
Study Start Date: October 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (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.


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 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
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Please refer to this study by its identifier: NCT00634036

United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Vermont
University of Vermont
Colchester, Vermont, United States, 05446
Sponsors and Collaborators
University of Pittsburgh
University of Vermont
Principal Investigator: Fernando Holguin, MD, MPH University of Pittsburgh
Principal Investigator: Anne E. Dixon, MD University of Vermont
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Fernando Holguin, Principal Investigator, University of Pittsburgh Identifier: NCT00634036     History of Changes
Other Study ID Numbers: GLITZ 001
Study First Received: March 5, 2008
Last Updated: January 8, 2016

Keywords provided by University of Pittsburgh:
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 processed this record on April 26, 2017