- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02887911
Characterization of Adults for Asthma Microbiome Research Studies (CAARS)
Characterization of Adults for Asthma Microbiome Research Studies (CAARS)
Обзор исследования
Подробное описание
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
-
-
Michigan
-
Ann Arbor, Michigan, Соединенные Штаты, 48109
- University of Michigan
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
For all subjects:
Inclusion criteria:
- Men/Women, ages 18-75, with or without current asthma, are eligible to be screened.
Exclusion criteria:
- Cigarette smoking history of >30 total pack-years
- Current use of other smoked products or recreational drugs (e.g. pipes, cigars, e-cigarettes, other illicit drugs)
- History of lung disease other than asthma
- Recent upper respiratory tract infection treated with antibiotics within 8 weeks of visit 1
- Recent antibiotic use (except topical or ocular) within 8 weeks of visit 1 (chronic antibiotic use for asthma management allowed)
- Currently pregnant or breast-feeding
- Other medical conditions or treatments that may increase subject risk or affect study results, based on study physician judgment. These include the following: significant cardiovascular disease(+/- active symptoms), arrhythmia, or stroke, active cancer, post-organ transplant
- Any other condition for which subject is taking immunosuppressive therapies (except steroids for asthma)
- History of allergy to albuterol or methacholine
For asthma subjects only:
Note: Enrollment target is for 90 asthmatics already taking inhaled corticosteroids prescribed by their physician (any formulation and dose) and 60 subjects who are not currently using inhaled corticosteroid.
Additional inclusion criteria:
- History of asthma symptoms within the last 2 years (e.g. wheeze, shortness of breath, etc.)
- Evidence of stable asthma as assessed by initial screening
- No changes in asthma medications within 30 days of visit 1
- Methacholine PC20 (dose at which there is a 20 percent change) ≤ 8 mg/ml (for those asthmatics on inhaled steroids, PC20 ≤ 16 mg/ml), or change in FEV1 (forced expiratory volume in first second of spirometry effort)≥ 12% after 4 puffs of albuterol on reversibility testing (or PI discretion)
- If negative methacholine challenge or no evidence of bronchodilator reversibility, a strong history of physician-diagnosed/physician-managed asthma may allow for study inclusion, based on PI's judgement or discretion.
- Individuals with a history of physician-diagnosed asthma who have had bronchodilator reversibility testing or methacholine challenge performed within 60 days of screening may be enrolled and these existing test results used in lieu of repeating the same test at visit 1 or visit 2.
Additional exclusion criteria:
- An asthma exacerbation requiring treatment with oral or IV steroids within 1 month of visit 1
- No asthma symptoms within the last 2 years
- For healthy control or atopic non-asthma subjects:
Additional exclusion criteria:
- Evidence of abnormal lung function by any of the following: FEV1/FVC ratio <0.70, FEV1 or FVC (forced vital capacity on spirometry) < 80% predicted, methacholine PC20 < 16 mg/ml, or FEV1 improvement > 12% in response to albuterol
- Atopic non-asthma subjects found to have evidence of abnormal lung function, but without a clear or recent history of asthma, may be enrolled per PI's discretion.
- Possible pulmonary disease is identified by PI or Co-Is to explain an abnormal lung function result at the time of testing. The subject may be re-screened later at investigator's discretion.
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
---|
Asthmatic, not taking inhaled steroids
Men/Women, ages 18-75 who are not currently taking corticosteroids..
No intervention; this is a prospective observational study.
|
Asthmatic, taking inhaled steroids
Men/Women, ages 18-75 who are already taking corticosteroids prescribed by their physician.
No intervention; this is a prospective observational study.
|
Healthy, non-asthmatic without allergies
Men/Women, ages 18-75 without a current diagnosis of asthma and no allergies.
No intervention; this is a prospective observational study.
|
Healthy, atopic non-asthmatic
Men/Women, ages 18-75 with allergies but without a current diagnosis of asthma.
No intervention; this is a prospective observational study.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
---|---|
To characterize adult subjects with asthma in multiple domains, including disease severity and control, patterns of airway inflammation, microbial exposures and patterns of airway and gut microbial colonization
Временное ограничение: Day 1" for the first one and "up to 60 days"
|
Day 1" for the first one and "up to 60 days"
|
Вторичные показатели результатов
Мера результата |
Временное ограничение |
---|---|
To evaluate differences in airway and gut microbiota composition related to inhaled corticosteroid use (ICS) among asthmatics already regularly taking ICS, asthmatics not taking ICS, and healthy controls
Временное ограничение: Day 1" for the first one and "up to 60 days"
|
Day 1" for the first one and "up to 60 days"
|
Другие показатели результатов
Мера результата |
Временное ограничение |
---|---|
To apply culture and molecular methods to study functions of asthma-associated airway microbiota in corticosteroid-enriched environments
Временное ограничение: Day 1" for the first one and "up to 60 days"
|
Day 1" for the first one and "up to 60 days"
|
To evaluate the temporal stability of the airway microbiome in asthmatic and healthy subjects
Временное ограничение: Day 1" for the first one and "up to 60 days"
|
Day 1" for the first one and "up to 60 days"
|
To explore relationships between airway and gut microbiome composition in asthma, including among obese subjects
Временное ограничение: Day 1" for the first one and "up to 60 days"
|
Day 1" for the first one and "up to 60 days"
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Yvonne J. Huang, MD, University of Michigan
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- HUM00097163
- 5R01AI129958 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Здоровый
-
Drugs for Neglected DiseasesSanofiЗавершенныйПК в Healthy VolunteersФранция
-
Biotie Therapies Inc.PRA Health Sciences; Tandem Labs; Xceleron IncЗавершенныйН/Д, как Healthy VolunteersНидерланды
-
Newcastle UniversityЗавершенныйGI гликемический индекс здоровых добровольцев | Гликемическая нагрузка GL Healthy VolunteersСоединенное Королевство
-
CEN BiotechCEN Nutriment; Biovet Conseil; Amadeite SASЗавершенныйАнгедония в Healthy Volunteers