TGF-(Beta) and Susceptibility to RSV

NCT01224691 | Completed

• 2 other identifiers: 11000611-E-0006
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Keywords

TGF-Beta; Asthma; Natural History; Healthy Volunteer; Respiratory Syncytial Virus; RSV

Outcome Measures

Primary Outcomes (1)

• The primary hypothesis for Aim 1 is that asthmatics: cultured epithelia will have higher TGF-Beta expression levels than non-asthmatics.

  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.

  analysis

Study Arms (2)

Asmathics

Asmathics

Non-Asmathics

Non-Asmathics

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.@@@

You may qualify if:

• Male or female between 18 and 60 years of age
• Non-asthmatics and mild asthmatics as defined below:
• Non-asthmatic must have no prior diagnosis of asthma, no history of health care utilization or medication use for asthma, no current symptoms, and Forced Expiratory Volume in 1 Second (FEV1) greater than or equal to 80% predicted.
• Asthmatics must have physician-diagnosed asthma for at least one year and evidence of mild, persistent disease during the month prior to Visit 1 (based on 2008 GINA guidelines).
• a) Participants who are currently taking a controller medication must:
• i. use the equivalent to GINA Step 1 or 2 therapy; and
• ii. have controlled disease, as defined by:
• daytime symptoms less than or equal to 2 times week, such as wheezing, tightness in the chest, shortness of breath, and cough,
• no nocturnal symptoms;
• b) Participants who are not currently taking a controller must have:
• i.\<TAB\>daytime symptoms \> 1 time a week but \< 1 time a day, such as wheezing, tightness in the chest, shortness of breath, and cough;
• ii. nocturnal awakenings \> 2 times a month but \< 1 time a week;
• c) All asthmatic participants must have either:
• i.\<TAB\>Pre-bronchdilator FEV1 greater than or equal to 80% predicted and a positive methacholine challenge (PC20 less than or equal to 4 mg / ml); or
• ii.\<TAB\>Pre-bronchodilator FEV1 \< 80% and post-bronchodilator FEV1 greater than or equal to 80% with significant bronchodilator reversibility (at least 12% or 200ml change in FEV1)

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

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, 27709, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Asthma; Camurati-Engelmann Syndrome

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Stavros Garantziotis, M.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: October 20, 2010
• Study Start: March 19, 2012
• Last Updated: May 7, 2026

Record last verified: 2025-08-14

Locations

US (1)