TGF-(Beta) and Susceptibility to RSV
Condition: Asthma
MeSH terms: Disease Susceptibility
Study type: Observational

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 bronchoscopy,
           in which researchers insert a bronchoscope through the participant s nose or mouth and
           into the lungs to examine the lungs and collect lung cells.

        -  Participants will be contacted by a research team member 24 36 hours after the
           bronchoscopy to ask about any side effects from the procedure....
    

Detailed description: 
      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.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants will be individuals from the Research Triangle Park (RTP) area in North
        Carolina (see Section 6.2.1 for Recruitment Methods). Participants will be between the ages
        of 18 and 60 years and will be 1) healthy non-asthmatics and 2) mild asthmatics defined by
        2008 Global Initiative for Asthma (GINA) criteria.@@@
      
Keywords: TGF-Beta; Asthma; Natural History; Healthy Volunteer; Respiratory Syncytial Virus; RSV