NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
Part of paid clinical trials in Research Triangle Park, North Carolina.
- Sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Study ID
- NCT02327897
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- Sep 10, 2015
- Status verified
- Feb 2026
- Primary completion
- Apr 1, 2030
- Completion
- Apr 1, 2030
Study Design
- Enrollment
- 400 participants (estimated)
Arms
- Arm: asthmaticstudy group
- Arm: non-asthmaticcontrols
Primary Outcome Measure
The overall goal is to study the natural history of atopic asthma, focusing on moderate to severe asthma. The primary objective is to collect prospective data and samples for future use to better understand the interaction between environmental ... [ Time Frame: End of Study ]
Central Contacts
- NIEHS Join A Study Recruitment Group(855) 696-4347
- Stavros Garantziotis, M.D.(984) 287-4412
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| NIEHS Clinical Research Unit (CRU) | Research Triangle Park | North Carolina | 27709 | - |
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