Single Dose Study to Assess Efficacy, Safety and Tolerability of LAS100977 in Asthmatic Patients.
7 мая 2018 г. обновлено: AstraZeneca
A Phase IIa, Randomised, Single Dose, Double-blind, Double-dummy, 6 Way Complete Cross-over, Placebo Controlled Clinical Trial to Assess the Efficacy, Safety and Tolerability of 4 Doses of LAS100977 QD Compared to Placebo and an Active Comparator in Patients With Persistent Asthma.
The purpose of this study is to evaluate the pharmacodynamics of single doses of inhaled LAS100977 QD in patients with persistent asthma.
Обзор исследования
Статус
Завершенный
Условия
Тип исследования
Интервенционный
Регистрация (Действительный)
62
Фаза
- Фаза 2
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Berlin, Германия, 10117
- Almirall Investigational Sites#6
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Berlin, Германия, 14050
- Almirall Investigational Sites#4
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Berlin, Германия, 14057
- Almirall Investigational Sites#1
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Frankfurt, Германия, 60596
- Almirall Investigational Sites#3
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Grosshansdorf, Германия, 22927
- Almirall Investigational Sites#2
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Hamburg, Германия, 20249
- Almirall Investigational Sites#8
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Wiesbaden, Германия, 65187
- Almirall Investigational Sites#5
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London, Соединенное Королевство, W1G 8HT
- Almirall Investigational Sites#2
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Manchester, Соединенное Королевство, M3 9QZ
- Almirall Investigational Sites#1
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 18 лет до 70 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Adult male and female patients aged 18-70 years (both included).
- Clinical diagnosis of persistent asthma (according to GINA guidelines 2009 update) for at least 6 months prior to screening.
- Screening FEV1 value of 60% < FEV1 ≤ 85% of the predicted normal value.
- FEV1 reversibility ≥ 12% and an absolute increase of at least 200 ml over baseline value after inhalation of 400µg (four inhalations) of salbutamol.
- Pre-dose FEV1 value of first treatment period within the range of ± 20% of the FEV1 measured at screening prior to salbutamol inhalation.
- Patients on a stable dose and regimen
Exclusion Criteria:
- Current smokers, former smokers within the last 6 months, or ex-smokers with a history of more than 10 pack-years.
- Patients diagnosed with COPD.
- Recent Respiratory tract infections within 6 weeks before Screening Visit.
- Intubation (ever) or hospitalization for longer than 24 hours for the management of an asthma exacerbation within the preceding 6 weeks of the screening visit.
- Clinically significant respiratory conditions.
- Clinically significant cardiovascular conditions.
- Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
- Clinically relevant abnormalities laboratory, ECG parameters or physical examination results at the screening evaluation that in the investigator's opinion, preclude study participation.
- Patients who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required washout period for a particular prohibited medication.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: LAS100977 0.625 μg
Single-dose LAS100977 0.625 μg, during double-blind treatment period
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Dry powder inhalation, once-daily, single-dose
Pressurized inhalation, once-daily
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Экспериментальный: LAS100977 1.25 μg
Single-dose LAS100977 1.25 μg, during double-blind treatment period
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Pressurized inhalation, once-daily
Dry powder inhalation, once-daily, single-dose
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Экспериментальный: LAS100977 2.5 μg
Single-dose LAS100977 2.5 μg, during double-blind treatment period
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Pressurized inhalation, once-daily
Dry powder inhalation, once-daily, single-dose
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Активный компаратор: Salbutamol
Single-dose salbutamol 400 μg, during double-blind treatment period
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Pressurized inhalation suspension, once-daily, single-dose
Dry powder inhalation, once-daily
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Плацебо Компаратор: Placebo
Placebo to LAS100977, and placebo to salbutamol
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Pressurized inhalation, once-daily
Dry powder inhalation, once-daily
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Экспериментальный: LAS100977 0.313 μg
Single-dose LAS100977 0.313 μg, during double-blind treatment period
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Pressurized inhalation, once-daily
Dry powder inhalation, once-daily, single-dose
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
Временное ограничение: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
Временное ограничение: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
|
Peak Forced Expiratory Volume in One Second (FEV1)
Временное ограничение: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning on Day 1.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.
|
+15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
|
Time to Peak Forced Expiratory Volume in One Second (FEV1)
Временное ограничение: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.
|
+15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
|
Change From Baseline to Trough Forced Expiratory Volume in One Second (FEV1)
Временное ограничение: Baseline and +23 h and +24 h post-dose
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
|
Baseline and +23 h and +24 h post-dose
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Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24h at Day 1
Временное ограничение: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h
|
FEV1 was normalized to baseline.
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h
|
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Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint
Временное ограничение: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
|
Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
Временное ограничение: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
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Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
Временное ограничение: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
|
Change From Baseline in Peak Forced Vital Capacity (FVC)
Временное ограничение: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
|
Peak Forced Vital Capacity (FVC)
Временное ограничение: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h
|
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
|
+15 min, +30 min, +1 h, +2 h, +3 h, +4 h
|
|
Time to Peak Forced Vital Capacity (FVC)
Временное ограничение: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h
|
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
|
+15 min, +30 min, +1 h, +2 h, +3 h, +4 h
|
|
Change From Baseline to Trough Forced Vital Capacity (FVC)
Временное ограничение: Baseline and +23 h +24 h post-dose
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
|
Baseline and +23 h +24 h post-dose
|
|
Change From Baseline in Normalized Forced Vital Capacity (FVC) Area Under the Curve (AUC)
Временное ограничение: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h
|
FVC was normalized to baseline.
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h
|
|
Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint
Временное ограничение: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint
Временное ограничение: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Директор по исследованиям: Carol Astbury, PhD, AstraZeneca
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Полезные ссылки
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 августа 2011 г.
Первичное завершение (Действительный)
1 февраля 2012 г.
Завершение исследования (Действительный)
1 февраля 2012 г.
Даты регистрации исследования
Первый отправленный
29 августа 2011 г.
Впервые представлено, что соответствует критериям контроля качества
29 августа 2011 г.
Первый опубликованный (Оценивать)
30 августа 2011 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
8 мая 2018 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
7 мая 2018 г.
Последняя проверка
1 апреля 2018 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания дыхательных путей
- Заболевания иммунной системы
- Легочные заболевания
- Гиперчувствительность, немедленная
- Бронхиальные заболевания
- Заболевания легких, обструктивные
- Респираторная гиперчувствительность
- Гиперчувствительность
- Астма
- Физиологические эффекты лекарств
- Адренергические агенты
- Нейротрансмиттерные агенты
- Молекулярные механизмы фармакологического действия
- Автономные агенты
- Агенты периферической нервной системы
- Адренергические агонисты
- Бронхорасширяющие агенты
- Антиастматические агенты
- Агенты дыхательной системы
- Агенты репродуктивного контроля
- Агонисты адренергических бета-2 рецепторов
- Адренергические бета-агонисты
- Токолитические агенты
- Альбутерол
Другие идентификационные номера исследования
- M/100977/202
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. .