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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Takeda
University of Vermont
Information provided by (Responsible Party):
Fernando Holguin, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00634036
First received: March 5, 2008
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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
Asthma
Drug: pioglitazone
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 40
Study Start Date: October 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634036

Locations
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
Takeda
University of Vermont
Investigators
Principal Investigator: Fernando Holguin, MD, MPH University of Pittsburgh
Principal Investigator: Anne E. Dixon, MD University of Vermont
  More Information

Additional Information:
Publications:
Responsible Party: Fernando Holguin, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00634036     History of Changes
Other Study ID Numbers: GLITZ 001, 00001949
Study First Received: March 5, 2008
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Asthma
obesity
exacerbation
asthmatics
fat
overweight
adipose tissue
leptin
adiponectin
pioglitazone
Actos
wheezing
Pittsburgh
Pennsylvania
pulmonary
lung

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

ClinicalTrials.gov processed this record on August 19, 2014