NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
Eligible age
18–60 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: National Institute of Environmental Health Sciences (NIEHS)
You may not qualify if…
- ✕ Participants meeting any of the following criteria at screening will not be eligible for enrollment or to continue with study visits:
- ✕ Current smoker, significant second-hand smoke exposure (defined by urine cotinine \>200 ng/mL at screening), or a history of smoking greater than 5 pack years. Smoking encompasses all inhaled products, including e-cigarettes.
- ✕ piCO Smokealyzer value of \>11ppm
- ✕ History of the following comorbidities: chronic obstructive pulmonary disease, cystic fibrosis (CF), emphysema, non-CF bronchiectasis, pulmonary fibrosis, sarcoidosis, unstable angina, pulmonary hypertension
- ✕ Allergy or history of adverse reactions to methacholine
- ✕ Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures
- ✕ Comorbid diseases that affect global health or survival- such as DVT, pulmonary embolism, class III - IV congestive heart failure, or a malignancy under treatment
- ✕ Bronchoscopy Visit Exclusion Criteria
Where it's recruiting
Research Triangle Park
Source: ClinicalTrials.gov · NCT02327897 · last updated 2026-07-17