NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
- 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.
- Nonsmoking adults age 18 - 60 who have moderate to severe asthma and are not pregnant or breastfeeding.
- Partaicipants 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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Natural History of Asthma With Longitudinal Environmental Sampling|
- The overall goal is to study the natural history of bacteria and its impact on asthma [ Time Frame: End of Study ] [ Designated as safety issue: No ]
|Study Start Date:||December 2014|
|Estimated Study Completion Date:||January 2030|
|Estimated Primary Completion Date:||December 2029 (Final data collection date for primary outcome measure)|
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. Additionally, samples will be collected from the airways of approximately 20 participants enrolled in a 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, individuals who are allergic to methacholine, and women who are pregnant or breastfeeding, will not be eligible to enroll. Women who become pregnant or start breastfeeding after completing the screening and baseline visit assessments may continue their participation in the study but will not be eligible to participate in the 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02327897
|Contact: Lisa B Barber, MEd||(919) firstname.lastname@example.org|
|Contact: Stavros Garantziotis, M.D.||(919) email@example.com|
|United States, North Carolina|
|NIEHS Clinical Research Unit (CRU)||Recruiting|
|Research Triangle Park, North Carolina, United States|
|Principal Investigator:||Stavros Garantziotis, M.D.||National Institute of Environmental Health Sciences (NIEHS)|