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NCT01224691 · ClinicalTrials.gov registry record
TGF-(Beta) and Susceptibility to RSV
A clinical trial, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Completed
- Registry status
- 113
- Enrollment target
NCT01224691: Completed study, sponsored by National Institute of Environmental Health Sciences (NIEHS).
NCT01224691 is a clinical trial that has completed, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 113 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01224691 has completed, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- COMPLETED
- Registry status
- 113 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2012-03-19 |
What the finished NCT01224691 record still lists
NCT01224691 is an observational study that tracks outcomes without assigning an intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01224691 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01224691 about?
NCT01224691 is a clinical study titled "TGF-(Beta) and Susceptibility to RSV". 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 bet...
What is the current status of trial NCT01224691?
This trial is currently completed. The enrollment target is 113 participants. The study started on 2012-03-19.
Who is sponsoring clinical trial NCT01224691?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
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