TGF-(Beta) and Susceptibility to RSV

Completed

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01224691

Run by

National Institute of Environmental Health Sciences (NIEHS)

People needed

113

Starts

2012-03-19

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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
• Known or suspected respiratory infections within 30 days of Visit 1, such as flu, pneumonia, severe cold, tuberculosis, or bronchitis
• Known or suspected viral infection within 30 days of Visit 1
• History of chronic obstructive pulmonary disease other than asthma
• History of immunological disease or current cancer
• Uncontrolled cardiovascular disease such as angina, prior myocardial infarction, stroke, and high cholesterol
• Cardiac malformations
• Pulmonary hypertension
• Bleeding disorders
• Facial deformity, major facial surgery
• Currently pregnant or breast feeding
• Current smoker, significant second-hand smoke exposure (defined by urine cotinine > 100 ng/ml at Visit 1 or Visit 2) or former smokers (defined by a history of smoking > 100 cigarettes)
• Insulin dependent diabetes
• Used any of the following medications within 30 days of Visit 1: oral corticosteroids, systemic immunosuppressants or other immune-modifying drugs [e.g., Rituxan, Humira, Enbrel, Azathioprine (Imuran), Cyclosporine (Neoral, Sandimmune, and SangCya), cyclophosphamide, TNF antagonists], anticoagulants (clopidogrel, heparin, enoxaparin and related drugs, coumadin), and sustained use (i.e. more than one dose per day for more than two days) of non-steroidal anti-inflammatory drugs (aspirin, ibuprofen, indomethacin) within seven days of bronchoscopy
• Allergy or history of adverse reactions to methacholine or lidocaine
• Severe asthma as defined by a history of intubation for unstable asthma
• Any condition that, in the investigator's opinion, places the participant at undue risk for complications (e.g. from PFTs, fiberoptic bronchoscopy, bronchalveolar lavage and/or bronchial brushings)
• Temperature > 37.6 C; blood pressure < 90/50 mm Hg or blood pressure >170/95 mm Hg; pulse rate < 50 or > 100 beats/minute
• Body weight < 50 kg (<110 lbs)
• The following abnormal lab values (values obtained during clinical assessment):
• Platelet count < 100,000 per 10(9)/L
• White blood cells count < 3000 per 10(9)/L
• Hematocrit < 35% for both female and male
• Prothrombin Time (PT) / Abnormal International Normalized Ratio (INR) and partial prothromboplastin time (PTT) based on reference laboratory established reference ranges

Where it is running

• NIEHS Clinical Research Unit (CRU) — Research Triangle Park, North Carolina, United States

Full record on ClinicalTrials.gov

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