Asthma Sample Collection Protocol

  • STATUS
    Recruiting
Updated on 23 November 2020

Summary

Fiberoptic bronchoscopy is a procedure which involves passing a pencil-thin tube into the lung in order to collect fluid and cells from the airways. Fiberoptic bronchoscopy can collect cells from the walls of airways by gently brushing them (bronchial brushing). In addition, squirting small amounts of sterile water in to the airway and gently suctioning it back into the bronchoscope (bronchoalveolar lavage) collects cells.

In this study, researchers plan to perform these tests on patients with asthma and normal volunteers. This research may help to improve the understanding of the processes involved in airway inflammation and asthma.

Please visit our Patient Recruitment Pages for more information:

 

Description

This tissue procurement protocol proposes to perform bronchoscopy with bronchoalveolar lavage, bronchial brushings, and bronchial wall biopsies as well as to collect samples of sputum, exhaled breath condensates and blood, in order to evaluate the molecular mechanisms underlying the pathogenesis of airway inflammation, airway hyperresponsiveness, and airway remodeling in asthmatic subjects.

 

Please visit our Patient Recruitment Pages for more information:
  • A Study for Adults with Asthma
  • Healthy Volunteers for Lung Study
  • Details
    Condition Asthma
    Clinical Study IdentifierTX218198
    Last Modified on23 November 2020

    Eligibility

    Yes No Not Sure

    Inclusion Criteria

    ASTHMATICS
    Patients will be between 18 and 75 years of age, male or female
    The diagnosis of asthma requires a history of intermittent, reversible expiratory flow limitation
    In addition, patients will have demonstrated evidence of either an abnormal methacholine challenge or reversible airway obstruction
    An abnormal methacholine challenge will be defined as a decrease in FEV(1) of at least 20% at a PD(20) dose less than 240 micrograms
    Reversible airway obstruction will be defined as an improvement of at least 12% and 200 cc in either the FEV(1) or FVC folowing bronchodilator treatment
    Methacholine challenge testing will not be performed if the subject has a history of allergy to methoacholine
    Result of testing performed by the subject's primary care provider may be accepted as evidence of reversible airflow obstruction
    For women of childbearing potential, negative pregnancy test prior to study and willingness to adhere to reliable birth control methods during the study
    Asthmatic research subjects who will only be providing research blood specimens and will not be undergoing a research bronchoscopy may participate in the protocol by providing a clinical history that they have asthma and are not pregnant. Documentation of an abnormal methacholine challenge or reversible airflow obstruction or a negative pregnancy test, for women of childbearing age, will not be required for donation of research blood specimens
    RESEARCH VOLUNTEERS
    Research volunteers will be between 18 and 75 years of age, male or female
    A negative inhalational methacholine challenge as defined bv the absence of a 20% decrease in FEV(1), at a PD(20) dose of >960 micrograms (normal bronchial hyperresponsiveness). Methacholine challenge testing will not be performed if the subject has a history of allergy to methacholine. Results of testing performed by the subject's primary care provider may be accepted as evidence of a negative methacholine challenge
    For women of childbearing potential, negative pregnancy test within 2 weeks prior to study and willingness to adhere to reliable birth control methods during the study
    Research volunteers who will only providing research blood specimens and will not be undergoing a research bronchoscopy may be included in the protocol without documentation of a negative inhalational methacholine challenge or a negative pregnancy test if they provide a history that they do not have asthma and that they are not currently pregnant, for women of childbearing age

    Exclusion Criteria

    ASTHMATICS
    Diagnosis of a pulmonary disorder other than asthma (e.g., chronic bronchitis, cystic fibrosis, HIV-related lymphocytic airway inflammation)
    History of drug or alcohol abuse within the past year
    Positive test for human immunodeficiency virus (to exclude patients with HIV-related lymphocytic airway inflammation)
    RESEARCH VOLUNTEERS
    Same as the asthmatic exclusion criteria plus a history of asthma
    Clear my responses

    How to participate?

    Step 1 Connect with a study center
    What happens next?
    • You can expect the study team to contact you via email or phone in the next few days.
    • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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    Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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    If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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    Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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