AsthmaNCT01224691
TGF-(Beta) and Susceptibility to RSV
An observational study of Asthma, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2012to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.@@@
Who may be able to join
None listed.
Who cannot join
- 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
Show all 26Show fewer
- 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
- Serum creatinine > 1.4 mg/dL
Trial locations and contacts
1 site in 1 country.
United States1 site
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, 27709
About this study
Official title: The Role of TGF-Beta in Asthmatic Epithelial Cell Susceptibility to RSV Infection
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Asthma
- Keywords
- TGF-Beta, Asthma, Natural History, Healthy Volunteer, Respiratory Syncytial Virus, RSV
- Medical subject headings
- Asthma, Camurati-Engelmann Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asmathics | Asmathics | |
| Non-Asmathics | Non-Asmathics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study start19 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stavros Garantziotis, M.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224691
- Sponsor's protocol ID
- 110006
- Other IDs
- 11-E-0006
- Status last verified
- 30 Jun 2026
- First submitted
- 19 Oct 2010
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It has not been decided yet if we will share the data
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of TGF-Beta in Asthmatic Epithelial Cell Susceptibility to RSV Infection
- ClinicalTrials.gov ID
- NCT01224691
- Acronym / sponsor ID
- 110006
- Conditions
- Asthma
- Keywords
- TGF-Beta, Asthma, Natural History, Healthy Volunteer, Respiratory Syncytial Virus, RSV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 19 Mar 2012 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asmathics | – | –Asmathics |
| Non-Asmathics | – | –Non-Asmathics |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.@@@
Key inclusion criteria (0 listed)
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It has not been decided yet if we will share the data
Related trials for Asthma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stavros Garantziotis, M.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary hypothesis for Aim 1 is that asthmatics: cultured epithelia will have higher TGF-Beta expression levels than non-asthmatics. (time frame: analysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.