Ignite Creation Date:
2024-05-06 @ 3:34 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02327897
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2014-12-30
Brief Title:
NHALES Natural History of Asthma With Longitudinal Environmental Sampling
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Natural History of Asthma With Longitudinal Environmental Sampling
Status:
RECRUITING
Status Verified Date:
2024-10-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 peoples 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
- 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 peoples 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
Detailed 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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 15-E-0058 | None | None | None |