Functional Activity of Airway Eosinophils in Allergic Disease

This study is currently recruiting participants.
Verified February 2014 by University of Wisconsin, Madison
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01026532
First received: December 2, 2009
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Asthma
Biological: Segmental Allergen Challenge

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Functional Activity of Airway Eosinophils in Allergic Disease

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • The primary endpoint of this study is to use segmental antigen challenge by bronchoscopy to elicit airway eosinophilia and to retrieve cells from the airway for analysis of their function. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Measurement taken at 48 hours after segmental antigen challenge.


Estimated Enrollment: 38
Study Start Date: November 2009
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Segmental antigen challenge
Segmental allergen challenge: Briefly, this procedure will be done during a bronchoscopy. Two airway tubes of the lung will have about 1 teaspoon of allergen put in it while the scope is wedged in an airway tube segment. The allergen will stimulate this portion of the airway tube to produce eosinophils. The scope will then be removed. The bronchoscopy will be repeated two days later to collect lung fluid and biopsy samples from the parts of the lung where the allergen solution was placed.
Biological: Segmental Allergen Challenge
Segmental allergen challenge: Briefly, this procedure will be done during a bronchoscopy. Two airway tubes of the lung will have about 1 teaspoon of allergen put in it while the scope is wedged in an airway tube segment. The allergen will stimulate this portion of the airway tube to produce eosinophils. The scope will then be removed. The bronchoscopy will be repeated two days later to collect lung fluid and biopsy samples from the parts of the lung where the allergen solution was placed.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026532

Contacts
Contact: Michele Wolff, BSN (608) 263-0524 mjwolff@medicine.wisc.edu
Contact: Gina M Crisafi, BS (608) 265-4554 gmc@medicine.wisc.edu

Locations
United States, Wisconsin
Univeristy of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Nizar N Jarjour, MD    608-263-9344    nnj@medicine.wisc.edu   
Principal Investigator: Nizar N Jarjour, MD         
Sub-Investigator: Loren Denlinger, MD, PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01026532     History of Changes
Other Study ID Numbers: H-2009-0050
Study First Received: December 2, 2009
Last Updated: February 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014