Clinical Trial: TGF-(Beta) and Susceptibility to RSV

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: The Role of TGF-Beta in Asthmatic Epithelial Cell Susceptibility to RSV Infection

Brief Summary:

Background:

  • Human respiratory syncytial virus (RSV) is a virus that causes respiratory tract infections, and is frequently responsible for hospital visits in infants and children. It can also trigger severe breathing problems for individuals who have asthma, but these infections are generally better tolerated in non-asthmatics. Some research suggests that lack of an efficient immune system response in people with asthma may make it difficult for the body to fight the effects of RSV.
  • Transforming Growth Factor-beta (TGF-[beta]) is a chemical in the body that is more prevalent in the lungs of people with asthma and related respiratory disorders. More information is needed about the effects of TGF-[beta] and whether it makes individuals with asthma more prone to developing RSV. Researchers hope to use this information to determine possible treatments and therapies for individuals with asthma who contract RSV.

Objectives:

- To determine the possible role of TGF-[beta] in increased asthmatic susceptibility to RSV infection.

Eligibility:

- Individuals between 18 and 60 years of age who are either healthy nonsmokers or mild asthmatics.

Design:

  • This study involves a screening visit and a study visit.
  • Participants will be screened with a medical history and physical examination, as well as blood samples and a pulmonary function test.
  • At the study visit, participants will receive mild anesthetic and have a bronchos

    Detailed Summary:

    This is a cross-sectional, controlled study designed to investigate whether Transforming Growth Factor-beta (TGF-beta) mediates increased asthmatic epithelial susceptibility to respiratory syncytial virus (RSV) infection by examining responses to RSV infection in epithelial cells cultured from asthmatic and non-asthmatic participants. Non-smoking healthy adults and mild asthmatics, aged 18-60 years old, will be recruited to participate. Potential participants will be prescreened and scheduled for a final eligibility visit that will include medical history review, vital signs, physical examination, blood draw, and pulmonary function tests (PFTs). After eligibility is confirmed, the participant will be scheduled for bronchoscopy. During the bronchoscopy, bronchial epithelia and alveolar macrophages will be obtained from the participant for analysis. Alveolar macrophages will be evaluated ex-vivo for inflammatory activity at baseline and after stimulation.

    The primary objective of the laboratory analysis is to determine if TGF-beta mediates increased asthmatic epithelial susceptibility to RSV infection. The study has three aims which are interrelated: 1) To determine if asthmatic bronchial epithelia express more TGF-beta than normal epithelia; 2) to determine if RSV replication is greater in asthmatic epithelia than normal epithelia; and 3) to determine if TGF-beta mediates asthmatic bronchial epithelial susceptibility to RSV infections.


    Sponsor: National Institute of Environmental Health Sciences (NIEHS)

    Current Primary Outcome:

    Original Primary Outcome:

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: National Institutes of Health Clinical Center (CC)

    Dates:
    Date Received: October 19, 2010
    Date Started: October 3, 2010
    Date Completion:
    Last Updated: April 21, 2017
    Last Verified: January 5, 2017