Status:
COMPLETED
TGF-(Beta) and Susceptibility to RSV
Lead Sponsor:
National Institute of Environmental Health Sciences (NIEHS)
Conditions:
Asthma
Eligibility:
All Genders
18-60 years
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 trigg...
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 v...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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)
- 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
- 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
- Serum creatinine \> 1.4 mg/dL
Exclusion
Key Trial Info
Start Date :
March 19 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT01224691
Start Date
March 19 2012
Last Update
January 8 2026
Active Locations (1)
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1
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, United States, 27709