- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01747629
Efficacy of Inhaled Albuterol Spiromax® in Subjects With Persistent Asthma With Steady State Pharmacokinetics
A 12-week Comparison of the Efficacy and Safety and Steady-State Pharmacokinetics of Albuterol Spiromax® Versus Placebo in Subjects 12 Years and Older With Persistent Asthma
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 3
Контакты и местонахождение
Места учебы
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California
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Costa Mesa, California, Соединенные Штаты
- Teva Investigational Site 10225
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Encinitas, California, Соединенные Штаты
- Teva Investigational Site 10250
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Huntington Beach, California, Соединенные Штаты
- Teva Investigational Site 10230
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Palmdale, California, Соединенные Штаты
- Teva Investigational Site 10255
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Rancho Mirage, California, Соединенные Штаты
- Teva Investigational Site 10231
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Riverside, California, Соединенные Штаты
- Teva Investigational Site 10252
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Rolling Hills Estates, California, Соединенные Штаты
- Teva Investigational Site 10242
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San Diego, California, Соединенные Штаты
- Teva Investigational Site 10238
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San Jose, California, Соединенные Штаты
- Teva Investigational Site 10243
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Florida
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Miami Lakes, Florida, Соединенные Штаты
- Teva Investigational Site 10247
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Tallahassee, Florida, Соединенные Штаты
- Teva Investigational Site 10239
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Tampa, Florida, Соединенные Штаты
- Teva Investigational Site 10234
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Maine
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Bangor, Maine, Соединенные Штаты
- Teva Investigational Site 10253
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Maryland
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Baltimore, Maryland, Соединенные Штаты
- Teva Investigational Site 10257
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White Marsh, Maryland, Соединенные Штаты
- Teva Investigational Site 10254
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Massachusetts
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Fall River, Massachusetts, Соединенные Штаты
- Teva Investigational Site 10235
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North Dartmouth, Massachusetts, Соединенные Штаты
- Teva Investigational Site 10236
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Minnesota
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Minneapolis, Minnesota, Соединенные Штаты
- Teva Investigational Site 10226
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Minneapolis, Minnesota, Соединенные Штаты
- Teva Investigational Site 10233
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Missouri
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St. Louis, Missouri, Соединенные Штаты
- Teva Investigational Site 10241
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Nebraska
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Bellevue, Nebraska, Соединенные Штаты
- Teva Investigational Site 10229
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New York
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Rochester, New York, Соединенные Штаты
- Teva Investigational Site 10227
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North Carolina
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Charlotte, North Carolina, Соединенные Штаты
- Teva Investigational Site 10244
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Ohio
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Cincinnati, Ohio, Соединенные Штаты
- Teva Investigational Site 10248
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Oklahoma
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Oklahoma City, Oklahoma, Соединенные Штаты
- Teva Investigational Site 10249
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Oregon
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Eugene, Oregon, Соединенные Штаты
- Teva Investigational Site 10232
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Medford, Oregon, Соединенные Штаты
- Teva Investigational Site 10259
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Portland, Oregon, Соединенные Штаты
- Teva Investigational Site 10237
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Pennsylvania
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Bethlehem, Pennsylvania, Соединенные Штаты
- Teva Investigational Site 10240
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Pittsburgh, Pennsylvania, Соединенные Штаты
- Teva Investigational Site 10246
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Pittsburgh, Pennsylvania, Соединенные Штаты
- Teva Investigational Site 10256
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South Carolina
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Rock Hill, South Carolina, Соединенные Штаты
- Teva Investigational Site 10251
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Spartanburg, South Carolina, Соединенные Штаты
- Teva Investigational Site 10228
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Texas
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San Antonio, Texas, Соединенные Штаты
- Teva Investigational Site 10258
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Washington
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Seattle, Washington, Соединенные Штаты
- Teva Investigational Site 10245
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Written informed consent/assent
- At least 12 years of age at screening
- General good health
- Persistent asthma for ≥3 months, with an FEV1 50-80% predicted and ≥15% reversibility
- Taking inhaled corticosteroids at a stable dose (≤ equivalent of 500mcg of fluticasone propionate/day) for at least 4 weeks prior to the Screening Visit.
- Ability to perform spirometry in an acceptable manner as per protocol guidelines
- Other inclusion criteria apply
Exclusion Criteria:
- A known hypersensitivity to albuterol or any of the excipients in the formulations.
- History of a respiratory infection or disorder that has not resolved within 1 week preceding the Screening Visit (SV).
- History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation.
- Any asthma exacerbation requiring oral corticosteroids within 3 months of the SV. A subject must not have had any hospitalization for asthma within 6 months prior to the SV.
- Hospitalization due to asthma exacerbation 2 or more times in the past year
- Initiation of immunotherapy or dose escalation during the study period
- Other exclusion criteria apply.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Плацебо Компаратор: Placebo MDPI
Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
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Placebo MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.
Другие имена:
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Экспериментальный: Albuterol MDPI
Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
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Albuterol MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period
Временное ограничение: Day 1, Day 8 and Day 85
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FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average (by the trapezoidal rule) over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure (i.e., change from baseline at each timepoint) recorded on days 1, 8 and 85 of the treatment period. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day. FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min. |
Day 1, Day 8 and Day 85
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1
Временное ограничение: Day 1
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FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min. |
Day 1
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Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8
Временное ограничение: Day 8
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FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min. |
Day 8
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Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85
Временное ограничение: Day 85
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FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min. |
Day 85
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Participants With Adverse Events
Временное ограничение: Day 1 to Day 93
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Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs).
An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug.
Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities.
Relation of AE to treatment was determined by the investigator.
Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
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Day 1 to Day 93
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Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group
Временное ограничение: Day 1 (Baseline), Day 85
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Physical exam was recorded as normal or abnormal based on physician assessment.
Format for results is: Test Baseline/Endpoint.
HEENT = head, eyes, ears, nose, throat.
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Day 1 (Baseline), Day 85
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Participants With Clinically Significant Vital Sign Assessments
Временное ограничение: Days 8 and 85
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For both standard and serial vital signs, participants were seated for at least 5 minutes before vital signs were assessed. Heart rate was obtained prior to the blood pressure measurement. Serial heart rate and blood pressure were conducted in the sitting position prior to the spirometry assessment; baseline measures were taken pre-dose at -30 ± 5 and -5 minutes on Day 1. Day 85 serial vital sign measures were taken in the sitting position prior to spirometry assessments pre-dose at -30 ± 5 and -5 minutes, then post-dose at 30 (±5) minutes, 1hr (± 10 min), 2hr (± 10 min), 3hr (± 10 min), 4hr (± 10 min), 5hr (± 10 min) and 6 hr (± 10 min). Serial heart rate and blood pressure measurements that were elevated to the following criteria were considered clinically significant: Systolic blood pressure: > 160 beats/minute Diastolic blood pressure: >100 beats/minute Heart rate: >120 beats/minute |
Days 8 and 85
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Maximum Observed Plasma Drug Concentration (Cmax) for Albuterol on Days 1 and 8
Временное ограничение: Days 1 and 8
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Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes).
Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).
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Days 1 and 8
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Time to Observed Peak Plasma Concentration (Tmax) for Albuterol on Days 1 and 8
Временное ограничение: Days 1 and 8
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Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes).
Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).
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Days 1 and 8
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Area Under the Concentration-time Curve From Time 0 (Pre-dose) up to 6 Hours Post-dose (AUC0-6) for Albuterol on Days 1 and 8
Временное ограничение: Days 1 and 8
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Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min). AUC0-6 on Day 8 is not from pre-dose but at steady state. |
Days 1 and 8
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Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Last Time of Quantifiable Concentration (AUC0-t) for Albuterol on Days 1 and 8
Временное ограничение: Days 1 and 8
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Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min). AUC0-t on Day 8 is not from pre-dose but at steady state. |
Days 1 and 8
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Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Infinity Post-dose(AUC0-inf) for Albuterol on Day 1
Временное ограничение: Day 1
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Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes).
Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).
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Day 1
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Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 24 Hours Post-dose(AUC0-24) for Albuterol on Day 8
Временное ограничение: Day 8
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Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes).
Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).
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Day 8
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Terminal Plasma Half-life (t1/2) for Albuterol on Days 1 and 8
Временное ограничение: Days 1 and 8
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Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes).
Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).
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Days 1 and 8
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Соавторы и исследователи
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 (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
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
- ABS-AS-304
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 Placebo MDPI
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University of FloridaЗавершенныйАпноэ сна, обструктивное | ХрапСоединенные Штаты
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Centre Hospitalier Universitaire de Saint EtienneЗавершенный
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PfizerЗавершенныйАтопический дерматитКитай, Япония, Корея, Республика
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Tasly Pharmaceutical Group Co., LtdНеизвестныйСиндром раздраженного кишечника с диареейКитай
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Guang'anmen Hospital of China Academy of Chinese...НеизвестныйИшемическая болезнь сердца | Нестабильная стенокардия | Синдром застоя кровиКитай
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University Hospital, Clermont-FerrandРекрутингОральный мукозитФранция
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Henan University of Traditional Chinese MedicineJiangsu Province Hospital of Traditional Chinese MedicineНеизвестныйХроническое обструктивное заболевание легкихКитай
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Universidad Francisco de VitoriaЗавершенныйПищевая добавка | Спортивная производительностьИспания
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TakedaЗавершенныйХроническая бессонницаСоединенные Штаты
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TakedaЗавершенныйХроническая бессонница