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Your Environment. Your Health.

NHALES Study (Natural History of Asthma with Longitudinal Environmental Sampling)

Study Background

This study will collect samples and data to examine the interaction between environmental exposures and disease progression over time in people with moderate-to-severe atopic asthma. The secondary objective is to develop an asthma clinic at the NIEHS Clinical Research Unit (CRU) in Research Triangle Park, N.C., to provide treatment to underserved populations. Participants will be enrolled for five years and will receive standard asthma care therapy.

Samples of blood, urine, DNA, saliva, sputum, stool, and household dust will be collected from approximately 200 participants, as well as quality of life information using asthma symptom questionnaires and, if consented, using home devices. Additionally, samples will be collected from the airways of participants enrolled in the bronchoscopy visit. The samples and survey information collected may be used to explore the microbiological and genetic influences of atopic asthma. Data from the analyses of these samples and survey responses may be evaluated in the context of the environmental exposures, clinical outcomes — such as symptoms, exacerbations, and quality of life — and response to therapy.

Collection of data and samples will be done in person at the CRU and at the participant’s home with the aid of an investigator-supplied air quality monitor, at-home spirometry test, and a cell phone with a custom application. Participants have the option to download the application on their personal cell phone. Comparator data from non-asthmatic participants enrolled through on-going studies at the CRU will be used to compare microbiome abundance and diversity in our population of subjects.

Eligibility Criteria

Participants must meet all the following criteria for enrollment:

  • Male or female, aged 18 to 60 years.
  • Must have clinical evidence of moderate-severe atopic asthma within the past year, such as wheezing, chest tightness, shortness of breath, and cough nocturnal symptoms.
  • Must have a positive methacholine test confirming asthma diagnosis.
  • Non- smoker with no significant second-hand smoke exposure or a history of smoking greater than 5 pack years.
  • No history of the following conditions: 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.
  • Free from illnesses or conditions that, in the investigator’s opinion, places the participant at undue risk for complications associated with study procedures.

Principal Investigator

Stavros Garantziotis, M.D.
Stavros Garantziotis, M.D.
Medical Director, NIEHS Clinical Research Unit
Tel 984-287-4412
Fax 919-541-9854
garantziotis@niehs.nih.gov
P.O. Box 12233
Mail Drop CU-01
Durham, N.C. 27709
Rebecca Church
Rebecca L. Church
Clinical Research Coordinator
Tel 984-287-4421
rebecca.church@nih.gov
P.O. Box 12233
Mail Drop CU-01
Durham, N.C. 27709
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