TGF-(Beta) and Susceptibility to RSV (NCT01224691) | Clinical Trial Compass
CompletedNot Applicable
TGF-(Beta) and Susceptibility to RSV
United States113 participantsStarted 2012-03-19
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female between 18 and 60 years of age
. Non-asthmatics and mild asthmatics as defined below:
. Participants must be able to understand and provide written informed consent
. Participants must be able to travel to the CRU and the EPA
Exclusion criteria
. Use of oral steroid treatment(s) within 30 days of Visit 1
. Acute asthma-related healthcare utilization within 30 days of Visit 1, such as ED visits, systemic corticosteroids, and nebulizer treatment for asthma exacerbation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial studied TGF-Beta levels in airway cells from people with asthma compared to people without asthma — can you explain what TGF-Beta is and why higher levels of it might matter for my asthma or my risk of getting sick from RSV?
2Since this study has already been completed, have the results been published, and if so, what did they find about how TGF-Beta affects asthma patients' vulnerability to RSV infections?
3The trial focused on lab-grown airway cells rather than a treatment — does that mean findings from this kind of research might eventually lead to new therapies, and how far away could something like that realistically be?
4Given that this research looked at a biological difference between people with and without asthma, should I be taking any extra precautions right now to protect myself from RSV, especially during cold and flu season?
5Are there any ongoing or follow-up studies building on this TGF-Beta and RSV research that might be more directly relevant to my current treatment options or care plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary hypothesis for Aim 1 is that asthmatics: cultured epithelia will have higher TGF-Beta expression levels than non-asthmatics.
Timeframe: analysis
Trial details
NCT IDNCT01224691
SponsorNational Institute of Environmental Health Sciences (NIEHS)