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

Primary Purpose

Asthma, Obesity

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pioglitazone
Placebo
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Adipose Tissue, Asthmatics, Pioglitazone, Actos, Obesity, Exacerbation, Fat, Overweight, Leptin, Adiponectin, Wheezing, Vermont, Pulmonary, Lung

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Vermont Lung Center at the University of Vermont

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
November 5, 2008
Last Updated
February 25, 2015
Sponsor
University of Vermont
Collaborators
American Lung Association, University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT00787644
Brief Title
Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics (Glitz Asthma)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
new safety concerns which emerged about pioglitazone during the trial
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
American Lung Association, University of Pittsburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Obesity
Keywords
Asthma, Adipose Tissue, Asthmatics, Pioglitazone, Actos, Obesity, Exacerbation, Fat, Overweight, Leptin, Adiponectin, Wheezing, Vermont, Pulmonary, Lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Intervention Description
Pioglitazone tablets; 30 mg/day for 2 weeks; then increased to 45 mg/day until week 12 (approximately 3 months)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo (inert tablet)
Primary Outcome Measure Information:
Title
PC20
Description
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)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne E Dixon, MD
Organizational Affiliation
The Vermont Lung Center at the University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Vermont Lung Center at the University of Vermont
City
Colchester
State/Province
Vermont
ZIP/Postal Code
05446
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11815521
Citation
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.
Results Reference
background
PubMed Identifier
16815147
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. doi: 10.1016/j.jaci.2006.03.021. Epub 2006 May 19.
Results Reference
background
Links:
URL
http://www.nhlbi.nih.gov/health/dci/Diseases/Asthma/Asthma_WhatIs.html
Description
Asthma informational website
URL
http://www.ginasthma.com/
Description
Asthma informational website

Learn more about this trial

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

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