NHALES (Natural History of Asthma With Longitudinal Environmental Sampling) (NCT02327897) | Clinical Trial Compass
RecruitingNot Applicable
NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
United States400 participantsStarted 2015-09-10
Plain-language summary
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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
-\*a positive methacholine test confirming diagnosis \[provocative concentration causing a 20% fall in forced expiratory volume in 1 second (PC20 FEV1) \<16 mg/mL for participants on inhaled corticosteroids and \<8 mg/mL for participants not on inhaled corticosteroids\] or postbronchodilator FEV1 with at least 12% or 200 mL increase in FEV1 or forced volume vital capacity (FVC) on bronchodilator challenge, and
-no other diagnosis that could explain symptoms.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since NHALES is focused on studying the natural history of moderate to severe atopic asthma rather than testing a new treatment, what would my role actually look like — would I be providing data and samples over time, and how long would that commitment last?
2This trial involves ongoing environmental sampling alongside health data collection — what kinds of samples or environmental monitoring would I need to participate in, and how disruptive might that be to my daily life?
3Because this is a natural history study and not a treatment trial, does participating mean I would continue my current asthma medications as normal, or would there be any changes to how my asthma is managed while I'm enrolled?
4Given that the goal is to collect data for future research rather than to directly benefit me right now, is there any reason you think participating in NHALES would still be worthwhile for my situation, or would focusing on optimizing my current treatment be a better priority?
5Since the study is recruiting and focused on atopic asthma, do I fit the profile they're looking for — and are there any aspects of my asthma history or current severity that might affect whether this study is a good match for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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 ...
Timeframe: End of Study
Trial details
NCT IDNCT02327897
SponsorNational Institute of Environmental Health Sciences (NIEHS)