View Clinical Trial (Medical Research Study)
Functional Activity of Airway Eosinophils in Allergic Disease
| City: |
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Madison |
| State: |
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Wisconsin |
| Zip Code: |
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53792 |
| Conditions: |
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Asthma |
| Purpose: |
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The purpose of this study is to determine how a special white blood cell, the eosinophil,
can contribute to asthma. One of the characteristics of asthma is airway inflammation.
Airway inflammation in asthma may occur when an allergen is inhaled and sets up an allergic
reaction in the bronchial tubes. This reaction may lead to chest tightness, cough and
wheeze. To better understand the way in which the eosinophil can cause inflammation, the
investigators plan to study eosinophils that move in to the lung following an allergic
reaction.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Age 18-50 years
- Diagnosis of allergic rhinitis and/or mild asthma
- Pre-albuterol forced expiratory volume in the first second (FEV1) of >70% predicted.
- Skin test positive to house dust mite (D. farinae), short ragweed or cat hair
- Documented negative Tuberculin skin test (PPD) within the last 12 months or a medical
history that is consistent with a low probability of exposure to tuberculosis (i.e.
the subject is not a health worker, has not traveled to endemic areas, and has no
pre-existing medical or social risk factors for tuberculosis).
- At least a 20% decrease in FEV1 during the immediate response following inhaled
antigen challenge
- Safety laboratory assessments within normal ranges (labs to include complete blood
count with differential, blood urea nitrogen, creatinine, Prothrombin time, Partial
Thromboplastin Time and platelet count)
- Women of child-bearing potential (WCBP) must have a negative urine pregnancy test
(urine HCG) within 48 hours of the methacholine challenge at Visit 2, within 48 hours
of the inhaled allergen challenge at V3 and on the day of the segmental allergen
challenge on Visit 5. WCBP must agree to use a reliable method of birth control for
the duration of the study (reliable methods of birth control can include abstinence,
barrier methods, oral contraceptives, injection contraceptives or skin absorption
contraceptives).
- In the opinion of the investigator, capable and willing to grant written informed
consent and cooperate with study procedures and requirements
Exclusion Criteria:
- Major health problems such as autoimmune disease, heart disease, type I and II
diabetes, uncontrolled hypertension or lung diseases other than asthma. The listed
health problems are definitive exclusion but decisions regarding major health
problems not listed will be based upon the judgment of the investigator.
- No pre-existing chronic infectious disease.
- Any condition for which, in the opinion of the investigator, transient oxyhemoglobin
desaturation is inadvisable.
- Pregnant or lactating females or has a planned pregnancy during the course of the
study.
- Medication other than for asthma, allergies or contraception (e.g. monoamine oxidase
inhibitors and beta-adrenergic antagonists in any form).
- Inhaled corticosteroids or oral corticosteroids within 1 month of screening.
- Upper or lower respiratory infection within 1 month of screening.
- Unstable asthma as indicated by self report of increased symptoms or increased
beta-agonist use over the 2 weeks preceding the screening visit.
- Current smokers (defined as smoked within the last year) or a former smoker with a
history of >5 pack years.
- Obesity as defined by a Body Mass Index (BMI) >30.
- Use of an investigational drug within 30 days of entering the study
- History of noncompliance with medical regiments or subjects who are considered
unreliable including those with a psychiatric history that, in the opinion of the
investigator, may interfere with the conduct of study procedures.
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| NCT ID: |
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NCT01026532 |
| Primary Contact: |
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Michele Wolff, BSN
Phone: (608) 263-0524
Email: mjwolff@medicine.wisc.edu
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| Backup Contact: |
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Email: gmc@medicine.wisc.edu
Gina M Crisafi, BS
Phone: (608) 265-4554
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| Location Contact: |
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Madison, Wisconsin 53792
United States
Nizar N Jarjour, MD
Phone: 608-263-9344
Email: nnj@medicine.wisc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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