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

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: NCT00634036
Recruitment Status : Completed
First Posted : March 12, 2008
Results First Posted : July 19, 2017
Last Update Posted : July 19, 2017
University of Vermont
Information provided by (Responsible Party):
Fernando Holguin, University of Pittsburgh

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 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 or disease Intervention/treatment Phase
Asthma 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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 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
Study Start Date : October 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

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)
Other Name: Actos

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

Primary Outcome Measures :
  1. Airway Reactivity [ Time Frame: 12 weeks ]
    Presence and degree of airway hyperresponsiveness assessed by methacholine challenge test. PC20= Methacholine dose at wich the FEV1 deops by > 20% from pre-methacholine baseline values.

Secondary Outcome Measures :
  1. FEV1 % Predicted [ Time Frame: 12 weeks ]
  2. Juniper Asthma Control Questionnaire [ Time Frame: 12 weeks ]
    The Juniper Asthma Control Questionnaire is a validated scale ranging from 0 to 6. Higher scores represent poorer asthma control. Values > 1.5 are compatible with poorly controlled asthma

  3. Exhaled Nitric Oxide Ppb [ Time Frame: 12 weeks ]

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 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

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): 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
Fernando Holguin
University of Vermont
Principal Investigator: Fernando Holguin, MD, MPH University of Pittsburgh
Principal Investigator: Anne E. Dixon, MD University of Vermont

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
First Posted: March 12, 2008    Key Record Dates
Results First Posted: July 19, 2017
Last Update Posted: July 19, 2017
Last Verified: June 2017

Keywords provided by Fernando Holguin, 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