Completed

Cytokine Expression in Allergic Asthma

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What is being collected

Data Collection

Who is being recruted

Bronchial Diseases+6

+ Hypersensitivity

+ Hypersensitivity, Immediate

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Observational
Study Start: September 1994
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: July 2, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: September 14, 1994

Actual date on which the first participant was enrolled.

In the last 10 years it has become generally accepted that asthma is an inflammatory disease of the airways. T lymphocytes play a key role in regulating this inflammatory response, through the elaboration of cytokines such as IL-4, IL-5, and IFN-gamma. IL-5 is of particular interest because it is the major eosinophil survival factor in vivo. Eosinophils are felt to be the major effector cells in asthma, causing damage to various airway structures. The pulmonary late phase response, a worsening of airflow seen 4-8 hours after allergen inhalation, is associated with many of the inflammatory changes seen in chronic asthma. Current studies suggest that during the late phase response peripheral blood T cells traffic to the lungs and express cytokines, specifically IL-4 and IL-5. We propose to investigate this trafficking by determining the frequencies and phenotype of cells capable of producing the above cytokines in the peripheral blood in subjects with mild allergic asthma. These studies should lead to a clearer understanding of the cells and processes that lead to T cell trafficking to the lung and may yield a tool to evaluate the proposed anti-inflammatory therapies for asthma.

NCT00001408
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: July 2, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

250 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLung DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityRespiratory Tract DiseasesAsthma

Criteria

INCLUSION CRITERIA - BLOOD DRAW/ASTHMA: Age 18-65. Asthma of greater than one year duration. Willingness to adhere to effective contraception in women of child bearing age. Negative HIV test. EXCLUSION CRITERIA - BLOOD DRAW/ASTHMA: For blood draws of greater than 100 ml, a hemoglobin of less than 12.5 g/dl. For blood draws of 100 ml or less, performed less frequently than every 56 days, a hemoglobin of less than 10.0 g/dl. Current pregnancy. Medical history suggesting lung diseases other than asthma. History of immunodeficiency or HIV infection. INCLUSION CRITERIA - BLOOD DRAW/NORMAL CONTROL: Age 18-65. Willingness to adhere to effective contraception in women of child bearing age. Negative HIV test. EXCLUSION CRITERIA - BLOOD DRAW/NORMAL CONTROL: For blood draws of greater than 100 ml, a hemoglobin of less than 12.5 g/dl. For blood draws of 100 ml or less, performed less frequently than every 56 days, a hemoglobin of less than 10.0 g/dl. Current pregnancy. Positive skin test to one or more allergens in the battery tested. History of asthma or other allergic diseases, such as hay fever. Medical history suggesting lung diseases other than asthma. History of immunodeficiency or HIV infection. INCLUSION CRITERIA - EXHALED BREATH CONDENSATE/ASTHMA: Age 18-65. Asthma as diagnosed by a physician or use of medications consistent with the treatment of asthma. Subjects must have a doctor outside NIH and they will provide routine and emergency care. EXCLUSION CRITERIA - EXHALED BREATH CONDENSATE/ASTHMA: History of immunodeficiency or HIV infection. History of allergy to latex. INCLUSION CRITERIA - EXHALED BREATH CONDENSATE/HEALTHY CONTROL: Age 18 - 65. EXCLUSION CRITERIA - EXHALED BREATH CONDENSATE/HEALTHY CONTROL: History of asthma or other allergic diseases, such as allergic rhinitis. Medical history suggesting lung diseases other than asthma. History of allergy to latex. History of immunodeficiency or HIV infection.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps
CompletedOne Study Center