Clinical trial NCT00614874: The Use of Rosiglitazone to Treat Asthma
Official title: The Effects of the PPARy Agonist Rosiglitazone on Airway Hyperreactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Avandia
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 16
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Asthma is a common chronic disease characterized by airway inflammation and bronchoconstriction. This study utilizes the drug rosiglitazone (Avandia)to treat the effects of airway inflammation in patients with asthma.

The study will be conducted on 14 adult steroid naive patients with asthma. Patients with qualifying pulmonary function testing values will be eligible for enrollment. Enrolled subjects will be treated with rosiglitazone orally at 2mg dose for 4 weeks. Patients will be reassessed and dosing will increase in 4 week increments up to 8mg.

Detailed description: The current standard-of-care utilizes corticosteroids to down-regulate the inflammatory state in patients with asthma. However, corticosteroids have many side effects and are not universally effective. New safe anti-inflammatory agents are needed to help modulate the disease. Peroxisome proliferator-activated receptor agonists are widely used to manage diabetes mellitus, another common chronic disease. These agents have been study models and have been shown to have anti-inflammatory effects in lung tissue. Case reports have noted improvement in asthma symptoms in patients being treated with these agents. These agents are ideally placed for human research given their long record of safe use in the treatment of type 2 diabetes.

Eligibility criteria: Inclusion Criteria:

* Able to comprehend and grant a witnessed, written informed consent
* Must be greater than 19 years old
* Must be able to swallow a tablet
* Female participants must have a negative urine pregnancy test at visit 1 and throughout duration of the study
* Must have a history of physician diagnosed asthma
* Must have a baseline FEV1 \>60% predicted
* Must be able to perform pulmonary function testing
* Must have methacholine-induced decrease in FEV1 of 20%
* Must be capable of withholding medications that may affect the methacholine challenge test
* Must be able to withstand a 30 day washout period for all inhaled corticosteroids
* Must be able to attend all office visits, 4 weeks apart for 12 weeks. Each visit will last approximately 2-3 hours

Exclusion Criteria:

* Age 18 or younger
* FEV1 \<60% predicted value
* History or presence of significant renal, hepatic,neurologic, cardiovascular, hematologic, cerebrovascular, respiratory, endocrine, gastrointestinal, or collagen vascular disorder that in the Investigator's opinion could interfere with the study or require medical attention that would interfere with the study.
* History of cancer other than basal cell skin cancer
* History of hypoglycemia
* Current smokers, greater than 10 pack year history, or patients quitting less than 1 year prior to screening
* History within the past year of excessive alcohol intake or drug addiction
* History of respiratory infection requiring treatment with an antibiotic within 2 week prior to visit 1
* Chronic intermittent use of inhaled, oral, intra-muscular, topical or intravenous corticosteroids within 4 weeks of visit 1
* Inability to perform consistent spirometry or nitric oxide exhalation
* Treatment with an experimental, non-approved drug, or investigational drug within the past 30 days
* Known hypersensitivity to rosiglitazone
* History of noncompliance to medical regimens and participants who are considered to be potentially unreliable

Primary outcomes:
measure: Methacholine Responsiveness as Assessed by PC20,
timeFrame: patients were assessed at baseline and at 12 weeks
Secondary outcomes:
measure: Exhaled Nitric Oxide in Parts Per Billion (Ppb), Parts Per Billion
timeFrame: patients were assessed at baseline and 12 weeks
measure: Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: patients were assessed at baseline and 12 weeks
measure: Forced Expiratory Volume in One Second (FEV1) Percent Predicted
timeFrame: patients were assessed at baseline and 12 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University Medical Center, Department of Pulmonology and Critical Care
state: Nebraska
Study officials:
affiliation: Creighton University Medical Center
name: Tammy Wichman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matsuura H, Adachi H, Smart RC, Xu X, Arata J, Jetten AM. Correlation between expression of peroxisome proliferator-activated receptor beta and squamous differentiation in epidermal and tracheobronchial epithelial cells. Mol Cell Endocrinol. 1999 Jan 25;147(1-2):85-92. doi: 10.1016/s0303-7207(98)00214-7.
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