NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Asthma
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
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 asthma...
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 sub-study. 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. Women who are not pregnant or breastfeeding are preferred, however if a woman is found to be pregnant or breastfeeding at the screening or baseline visit (and has a good chance of being eligible), they may continue their participation in the study but will be excluded from participation in the methacholine challenge and bronchoscopy sub-study. 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 sub-study 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.
Tracking Information
- NCT #
- NCT02327897
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Stavros Garantziotis, M.D. National Institute of Environmental Health Sciences (NIEHS)