NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

ConditionAsthma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorNational Institute of Environmental Health Sciences (NIEHS)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, 18 to 60 years of age

self-reported symptoms suggestive of asthma (such as wheezing, chest tightness, shortness of breath, cough nocturnal symptoms)

Permanently resides within 50 miles of the CRU.

Able to present a valid government issued form of identification for entry to the NIEHS campus

Disqualifiers

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

Trial population

Participants will be recruited from the population at large, including asthmatic participants who visit the CRU for on-going studies. Participants who have successfully completed other CRU studies may be recruited directly for this study. The study will be registered on clinicaltrials.gov. Local public health departments and other clinics may be contacted for help with recruitment of individuals with moderate to severe atopic asthma. In addition, if needed, the study may be advertised in local media outlets.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 2 trial groups
Group A: asthmatic
Group B: non-asthmatic

Trial outcomes

Primary outcomes

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 ...

Results will be evaluated in the context of the environmental exposures, clinical outcomes (symptoms, exacerbations, and quality of life), and response to therapy.

Time frame
End of Study

Secondary outcomes

Other outcomes

Sponsors and contacts

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