Aerosol Inhalation Treatment for Dyspnea
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 2
- Фаза 1
Контакты и местонахождение
Места учебы
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02215
- Beth Israel Deaconess Medical Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Healthy
Exclusion Criteria:
- Unstable heart or circulation disease
- Stroke
- Seizure disorder
- Severe migraine headaches
- Liver or kidney disease
- Adrenal gland problem (Pheochromocytoma)
- Nerve problems that may affect your breathing sensation
- Brain cancer
- Drug or alcohol problem
- Systemic lupus erythematosis (SLE)
- High levels of depression, panic disorder, or other significant mental health problems
- Serious ongoing pain
- Pregnant
- Under 18 years old
- Not Fluent in English
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: F(40), then Saline, then IV.F
On Test Day 1, participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes. On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 4ml by inhalation for 5-10 minutes. On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes. |
Другие имена:
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Экспериментальный: IV.F, then F(40), then Saline
On Test Day 1, participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes. On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes. On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 4ml by inhalation for 5-10 minutes. |
Другие имена:
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Экспериментальный: Saline, then F(40), then IV.F
On Test Day 1, participants received Aerosol Saline 4ml by inhalation for 5-10 minutes. On Test Day 2 (at least 24 hours after Test Day 3), participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes. On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes. |
Другие имена:
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Экспериментальный: F(80), then Saline, then Saline
On Test Day 1, participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes. On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes. On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes. |
Другие имена:
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Экспериментальный: Saline, then F(80), then Saline
On Test Day 1, participants received Aerosol Saline 8ml by inhalation for 5-10 minutes. On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes. On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes. |
Другие имена:
|
|
Экспериментальный: Saline, then Saline, then F(80)
On Test Day 1, participants received Aerosol Saline 8ml by inhalation for 5-10 minutes. On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes. On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes. |
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Subject Rating of Breathing Discomfort (Dyspnea)
Временное ограничение: The breathing discomfort ratings were taken as an average of all ratings during runs before intervention and the first two runs after intervention. The 1st and 2nd post-runs began (on average) 12 minutes and 49 minute after intervention, respectively.
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Change in breathing discomfort (dyspnea) rating at benchmark PETCO2 using a visual analog scale.
The change in breathing discomfort is expressed as units on a 0% to 100% continuous scale, where higher values represent more dyspnea.
The change is represented as the rating of breathing discomfort after the intervention minus the rating of breathing discomfort before the intervention.
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The breathing discomfort ratings were taken as an average of all ratings during runs before intervention and the first two runs after intervention. The 1st and 2nd post-runs began (on average) 12 minutes and 49 minute after intervention, respectively.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Multidimensional Dyspnea Profile
Временное ограничение: Measured before intervention
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Characterization of subject's response to laboratory dyspnea model.
Data are from a baseline pre-treatment test on the first drug or placebo treatment day for the subjects used in the main analysis.
Subjects were asked to complete the MDP with reference to the last 30 sec of each run.
To weigh subjects equally, we selected one run from each subject: the first run that terminated in a rating of overall breathing discomfort (A1) of 50 to 90% of full scale.
The units of measurement are expressed as units on a 0 to 10 scale measuring intensity of a given quality, with higher values indicating greater intensity and 10 representing maximum perceived intensity.
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Measured before intervention
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Urine Output
Временное ограничение: Cumulative urine output 1 hour after intervention
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Diuresis is an expected effect of furosemide.
To the extent that aerosol furosemide is absorbed into the blood, diuresis is an expected 'side effect' of this treatment
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Cumulative urine output 1 hour after intervention
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Соавторы и исследователи
Следователи
- Главный следователь: Robert B Banzett, PhD, Beth Israel Deaconess Hospital
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
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
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2011-P-000027/1
- R01NR012009 (Грант/контракт NIH США)
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