- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01026532
Functional Activity of Airway Eosinophils in Allergic Disease
January 14, 2020 updated by: University of Wisconsin, Madison
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
31
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Wisconsin
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Madison, Wisconsin, United States, 53792
- Univeristy of Wisconsin Hospital and Clinics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Well-controlled allergic subjects with mild-intermittent asthma will be identified and undergo inhaled allergen provocation to demonstrate an allergen-specific airway response.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Measurement taken at 48 hours after segmental antigen challenge.
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48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 24, 2011
Primary Completion (ACTUAL)
March 31, 2017
Study Completion (ACTUAL)
March 31, 2017
Study Registration Dates
First Submitted
December 2, 2009
First Submitted That Met QC Criteria
December 3, 2009
First Posted (ESTIMATE)
December 4, 2009
Study Record Updates
Last Update Posted (ACTUAL)
January 18, 2020
Last Update Submitted That Met QC Criteria
January 14, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 2014-1481
- H-2009-0050 (OTHER: UW HS IRB)
- P01HL088594 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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