Actively Recruiting
NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
Led by National Institute of Environmental Health Sciences (NIEHS) · Updated on 2026-05-07
400
Participants Needed
1
Research Sites
759 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: \- Asthma is a serious clinical and public health problem. Researchers want to collect data to better understand how bacteria and other things in the environment can affect people's asthma. Eligibility: \- Nonsmoking adults age 18 - 60 who have moderate to severe asthma. Design: * Participants will complete a medical history form before the first visit. * Study visits will include collecting medical history, and conducting physical exam, lung and smoking tests. Participants will give blood, urine, stool, dust, saliva, and sputum samples. * Participants will take tests that measure their breathing abilities. They will give saliva samples for DNA study. They will get kits to collect stool and dust samples at home. They will fill out surveys. * Participants will have visits every 6 months for 5 years. They can schedule sick visits, if needed, at no cost to the participant. For all visits, they will have asthma check-ups and get treatment, at no cost to the participant. * Some participants may take part in a sub-study that includes one 4-hour visit. They will have medical history, physical exam, and lung tests. They will have urine tests to check for pregnancy and tobacco exposure. Then they will have bronchoscopy. For this, an intravenous line will be placed in an arm vein. The nose and throat will be numbed. A flexible fiber-optic tube will be inserted into their airways through the nose. Their airways will be examined and areas of their lung will be washed. A small sample of cells will be taken.
CONDITIONS
Official Title
NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 60 years
- Clinical evidence of moderate to severe atopic asthma with symptoms like wheezing, chest tightness, shortness of breath, or cough within the past year
- Positive methacholine test or bronchodilator response confirming asthma diagnosis
- No other diagnosis explaining asthma-like symptoms
- Permanently lives within 50 miles of the clinical research unit
- Able to provide valid government ID for study site access
- Able to receive asthma medications by mail
- Willing to follow medication, diet, and lifestyle instructions as directed
- Access to a vacuum cleaner with a detachable hose
- If pregnant or breastfeeding, may continue participation but will not undergo methacholine challenge or bronchoscopy procedures
- For bronchoscopy visit, able to fast for 6 hours prior to the procedure
You will not qualify if you...
- Current smoker or significant second-hand smoke exposure (urine cotinine >200 ng/mL) or history of smoking over 5 pack years
- piCO Smokealyzer value over 11 ppm
- History of chronic obstructive pulmonary disease, cystic fibrosis, emphysema, non-cystic fibrosis bronchiectasis, pulmonary fibrosis, sarcoidosis, unstable angina, or pulmonary hypertension
- Allergy or adverse reaction to methacholine
- Any condition posing undue risk for study procedures as judged by investigator
- Comorbid diseases affecting health or survival such as deep vein thrombosis, pulmonary embolism, class III-IV congestive heart failure, or cancer under treatment
- For bronchoscopy visit: pregnancy, bleeding disorders, major facial surgery or deformity, recent asthma exacerbation or respiratory infection within 4 weeks, severe persistent asthma, allergy to lidocaine, abnormal vital signs or lab values, body weight under 50 kg
- Active bronchospasm on day of bronchoscopy visit
AI-Screening
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Trial Site Locations
Total: 1 location
1
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, United States, 27709
Actively Recruiting
Research Team
N
NIEHS Join A Study Recruitment Group
CONTACT
S
Stavros Garantziotis, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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