TGF-(Beta) and Susceptibility to RSV
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|ClinicalTrials.gov Identifier: NCT01224691|
Recruitment Status : Completed
First Posted : October 20, 2010
Last Update Posted : June 18, 2021
- 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.
- To determine the possible role of TGF-[beta] in increased asthmatic susceptibility to RSV infection.
- Individuals between 18 and 60 years of age who are either healthy nonsmokers or mild asthmatics.
- 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.
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||118 participants|
|Official Title:||The Role of TGF-Beta in Asthmatic Epithelial Cell Susceptibility to RSV Infection|
|Actual Study Start Date :||March 19, 2012|
- The primary hypothesis for Aim 1 is that asthmatics: cultured epithelia will have higher TGF-Beta expression levels than non-asthmatics. [ Time Frame: analysis ]If En and Ea are the means of the logarithms of expression levels for the normal (non-asthmatic) and asthmatic populations, respectively, then the null hypothesis is H1,0: En= Ea and the one-sided alternative hypothesis is H1,0: En < Ea. This hypothesis will be tested with a one-sided, two-sample t-test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224691
|United States, North Carolina|
|NIEHS Clinical Research Unit (CRU)|
|Research Triangle Park, North Carolina, United States|
|Principal Investigator:||Stavros Garantziotis, M.D.||National Institute of Environmental Health Sciences (NIEHS)|