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

Study Background

This study will be a prospective, longitudinal, observational, single-center, exploratory, natural history study to collect samples and data that will enable prospective explorations of the interaction between environmental exposures and disease progression over time in moderate-severe atopic asthmatics with persistent disease, and facilitate the formation of mechanistic hypotheses. Environmental and body microbiome samples will be collected and stored from participants for future correlation to effects on asthma symptoms and control. 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, through the use of 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 (symptoms, exacerbations, and quality of life), and response to therapy.

Male and female participants aged 18 to 60 years old with moderate-severe, symptomatic atopic asthma will be enrolled. Participants will be excluded from enrollment if they have a history of chronic obstructive pulmonary disease, cystic fibrosis, non-cystic fibrosis bronchiectasis, pulmonary fibrosis, pulmonary hypertension, emphysema, sarcoidosis, or unstable angina. Additionally, participants will be excluded if they have DVT, pulmonary embolism, class III - IV congestive heart failure, or a malignancy under treatment. Current smokers, and individuals who are allergic to methacholine will not be eligible to enroll.

Participants will be enrolled for five years and will receive standard of care asthma therapy as indicated. After the initial screening and baseline visits, participants will return for visits semi-annually and for sick visits as needed. Volunteers participating in the bronchoscopy visit will have an additional single visit after completing the baseline visit.

This cohort of 200 participants will form the basis for future asthma study recruitment, and analysis of collected samples and data. Further expansion of the study beyond five years and 200 participants will be desirable if logistically possible.

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.
Medical Director, NIEHS Clinical Research Unit

Tel 984-287-4412
Fax 919-541-9854
garantziotis@niehs.nih.gov

Curriculum Vitae (80KB)

P.O. Box 12233

Mail Drop CU-01

Durham, N.C. 27709

Delivery Instructions