Trial record 18 of 2180 for:
"Asthma"
Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics (Glitz Asthma) (GLITZ)
This study is currently recruiting participants.
Verified June 2012 by University of Vermont
Sponsor:
University of Vermont
Collaborators:
American Lung Association
University of Pittsburgh
Information provided by (Responsible Party):
Anne Dixon, University of Vermont
ClinicalTrials.gov Identifier:
NCT00787644
First received: November 5, 2008
Last updated: June 22, 2012
Last verified: June 2012
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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 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 | Intervention | Phase |
|---|---|---|
|
Asthma Obesity |
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. (The GLITZ Asthma Study) |
Resource links provided by NLM:
Further study details as provided by University of Vermont:
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: | January 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 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)
|
| 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 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.
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 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787644
Contacts
| Contact: Laurianne V. Griffes, AS, BA | (802) 847-2193 | laurianne.griffes@vtmednet.org |
Locations
| United States, Vermont | |
| The Vermont Lung Center at the University of Vermont | Recruiting |
| Colchester, Vermont, United States, 05446 | |
| Contact: Anne E. Dixon, MD 802-847-2193 anne.dixon@uvm.edu | |
| Contact: Laurianne V. Griffes, AS, BA 802- 847-2193 laurianne.griffes@vtmednet.org | |
| Principal Investigator: Anne E. Dixon, MD | |
Sponsors and Collaborators
University of Vermont
American Lung Association
University of Pittsburgh
Investigators
| Principal Investigator: | Anne E Dixon, MD | The Vermont Lung Center at the University of Vermont |
More Information
Additional Information:
Publications:
| Responsible Party: | Anne Dixon, M.D., University of Vermont |
| ClinicalTrials.gov Identifier: | NCT00787644 History of Changes |
| Other Study ID Numbers: | GLITZ Asthma |
| Study First Received: | November 5, 2008 |
| Last Updated: | June 22, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Vermont:
|
Asthma Asthmatics Adipose Tissue Pioglitazone Actos Obesity Exacerbation Fat |
Overweight Leptin Adiponectin Wheezing Vermont Pulmonary Lung |
Additional relevant MeSH terms:
|
Asthma Obesity Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Pioglitazone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013