ТРОЙНОЙ ПРИ БАСТМЕ С НЕКОНТРОЛИРУЕМЫМ ПАЦИЕНТОМ, ПРИНИМАЮЩИЙ ИГКС ИКС + ДДБА средней силы (TRIMARAN)
52-НЕДЕЛЬНОЕ, РАНДОМИЗИРОВАННОЕ, ДВОЙНОЕ СЛЕПОЕ, МНОГОНАЦИОНАЛЬНОЕ, МНОГОЦЕНТРОВОЕ, АКТИВНО-КОНТРОЛИРУЕМОЕ, ПАРАЛЛЕЛЬНЫЕ ГРУППОВЫЕ ИССЛЕДОВАНИЯ, СРАВНЯЮЩИЕ CHF 5993 100/6/12,5 мкг pMDI (ФИКСИРОВАННАЯ КОМБИНАЦИЯ ЭКСТРАМЕЛКОГО БЕКЛОМЕТАЗОНА ДИПРОПИОНАТ ПЛЮС ФОРМОТЕРОЛ ФУМАРАТ 1005 ХРОНИДЕРУФ 1 ПЛЮС ГЛИКОПИЯ) /6 мкг pMDI (ФИКСИРОВАННАЯ КОМБИНАЦИЯ ЭКСТРАФИН БЕКЛОМЕТАЗОНА ДИПРОПИОНАТ ПЛЮС ФОРМОТЕРОЛ ФУМАРАТ) У БОЛЬНЫХ С АСТМОЙ, НЕ КОНТРОЛИРУЕМОЙ ПРИ СРЕДНИХ ДОЗАХ ИНГАЛЯЦИОННЫХ КОРТИКОСТЕРОИДОВ В КОМБИНАЦИИ С ДЛИТЕЛЬНО ДЕЙСТВУЮЩИМИ β2-АГОНИСТАМИ
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
This study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines, and following all other requirements of local laws.
From screening to the end of treatment, vital signs were recorded pre-dose at screening and pre- and postdose at all visits during the treatment period; physical examination was performed at all visits; concomitant medications and adverse events (AEs) were recorded, and asthma exacerbations were assessed at all visits; lung function tests were performed (pre-dose for forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC) from screening to end of treatment visits, pre-dose for inspiratory capacity and vital capacity and postdose serial spirometry at all visits during the treatment period).
Patients completed the electronic diary from home twice daily from the time of screening until the end of treatment, to record asthma symptoms, treatment compliance, and use of rescue medication. Patients used the electronic peak flowmeter to record peak expiratory flow twice daily from home from the time of screening until the end of treatment.
Asthma Control Questionnaire© (ACQ)-7 was completed at screening and all visits during the treatment period. The EuroQuality of Life-5-Dimensional-3-Level questionnaire, and health economic and outcome assessments were competed at all visits during the treatment period.
Rescue medication (salbutamol 100 μg per inhalation) was permitted throughout the treatment period when absolutely needed; the maximum allowed dose was 8 inhalations/day (800 μg).
An independent Data Safety Monitoring Board was established to provide impartial safety evaluation and assurance for patients.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 3
Контакты и местонахождение
Места учебы
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Rostock, Германия
- Chiesi Clinical Trial Site 276814
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Описание
Критерии включения:
- История астмы ≥ 1 года и диагноз до 40 лет
- Неконтролируемая астма с двойной терапией только средними дозами ингаляционных кортикостероидов (ICS) в сочетании с бета2-агонистом длительного действия (LABA) с ACQ-7 (опросник контроля астмы) ≥1,5
- ОФВ1 до бронходилататора <80% от прогнозируемого нормального значения
- Положительный тест на обратимость
- По крайней мере, 1 документально подтвержденное обострение астмы в течение предыдущего года.
Критерий исключения:
- Беременные или кормящие женщины
- Диагностика хронической обструктивной болезни легких (ХОБЛ)
- Пациенты с любым обострением астмы или инфекцией дыхательных путей за 4 недели до скрининга
- Текущие или бывшие курильщики (>= 10 пачек в год)
- Любое изменение дозы, графика или состава комбинации ICS + LABA за 4 недели до скрининга
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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Экспериментальный: CHF 5993 100/6/12.5 µg
CHF 5993 100/6/12.5 CHF 5993 100/6/12.5 µg: 2 inhalations bid Total daily dose: 400/24/50 µg BDP/FF/GB BDP=Beclometasone Dipropionate bid=Twice daily FF=Formoterol Fumarate GB=Glycopyrronium Bromide |
BDP=Beclometasone Dipropionate 100µg; FF=Formoterol Fumarate 6µg; GB=Glycopyrronium Bromide 12.5µg.
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Активный компаратор: CHF 1535 100/6 µg
CHF 1535 100/6 µg CHF 1535 100/6 µg: 2 inhalations bid Total daily dose: 400/24 µg BDP/FF BDP=Beclometasone Dipropionate bid=Twice daily FF=Formoterol Fumarate |
BDP=Beclometasone Dipropionate 100µg; FF=Formoterol Fumarate 6µg.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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1_Change From Baseline in Pre-Dose Forced Expiratory Volume in the First Second (FEV1) at Week 26
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 26.
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Change from baseline in pre-dose FEV1 was analysed at Week 26 of treatment. FEV1=Forced expiratory volume in the first second |
Week 0 (pre-treatment, baseline) to Week 26.
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2_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
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Asthma exacerbation (events): Moderate AND Severe. Severe: asthma worsening requiring initiation of treatment with systemic corticosteroids for at least 3 days (courses of corticosteroids separated by ≥1 week treated as separate severe exacerbations). Moderate: ≥1 of the following criteria fulfilled and leading to a change in treatment (sustained increase of ≥1 puff of short acting beta 2-agonist [SABA] for 2 consecutive days) as shown below:
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Week 0 (pre-treatment, baseline) to Week 52.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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20_Number of Patients at Risk of a MODERATE Asthma Exacerbation
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
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Data were analysed for the number of patients at risk of a MODERATE asthma exacerbation.
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Week 0 (pre-treatment, baseline) to Week 52.
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3_Change From Baseline in Peak(0-3h) FEV1 at Week 26
Временное ограничение: Week 0 (pre-treatment, baseline) and Week 26.
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Peak FEV1 was analysed within 3 hours post-dose. FEV1=Peak of forced expiratory volume in the first second |
Week 0 (pre-treatment, baseline) and Week 26.
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4_Change From Baseline in Morning Peak Expiratory Flow (PEF) Over the 26-Week Treatment
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 26.
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Change from baseline in the average morning PEF over the 26-Week treatment. PEF=Peak expiratory flow; is the volume of air forcefully expelled from the lungs in one quick exhalation. |
Week 0 (pre-treatment, baseline) to Week 26.
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5_Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period - Pooled Analysis
Временное ограничение: The entire treatment period; up to Week 52.
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Severe Asthma Exacerbation Rate over the 52-Week Treatment Period in a pre-specified pooled analysis of 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER). The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
The entire treatment period; up to Week 52.
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6_Change From Baseline in Peak FEV1 (0-3h) at All Clinical Visits
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
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Change from baseline in peak FEV1 (within 3 h post-dosing) at all clinical visits. Baseline for pre-dose FEV1 was calculated as average of the FEV1 measurements (L) from the visit 2 (V2) Pre45min & V2 Pre15min. If one of the two pre-dose values was missing, the baseline was equal to the available pre-dose value. |
Week 0 (pre-treatment, baseline) to Week 52.
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7_Change From Baseline in Pre-Dose FEV1 at All Clinical Visits
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
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Results show the change from baseline in pre-dose FEV1 at all clinical visits.
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Week 0 (pre-treatment, baseline) to Week 52.
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8_FEV1 Response (FEV1 ≥ 100 mL) at Week 26 and Week 52
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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Results show the percentage of patients classified as FEV1 responders at both Week 26 and Week 52.
FEV1 response: Change from baseline in pre-dose morning FEV1 ≥ 100 mL.
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Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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9_Change From Baseline in FEV1 Area Under the Curve (AUC) (0-3h) Normalised by Time at All Clinical Visits
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
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Baseline definition: mean of two pre-dose FEV1 measurements at visit 2 (V2). Results show the change from baseline in FEV1 area under the curve [AUC] (0-3h) at all subsequent visits (i.e. change from baseline of the AUC of the serial post-dose spirometry assessments till 3h post-dose). |
Week 0 (pre-treatment, baseline) to Week 52.
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10_Change From Baseline in the Asthma Control Questionnaire-7 (ACQ-7) Score at All Clinical Visits
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
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ACQ-7 Questionnaire. Asthma Control Questionnaire-7 (ACQ-7) allows assessment of asthma control in individual patients. The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue medication use and 1 on lung function (FEV1 % predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control (no impairment) and 6 indicating poor control (maximum impairment). The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question was completed by the study investigator using data from the Master Scope spirometer. Baseline for ACQ-7 was the total score recorded at Visit 2 (Week 0) of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. A negative change from baseline indicates improvement in lung function. |
Week 0 (pre-treatment, baseline) to Week 52.
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11_Asthma Control Questionnaire©-7 Response at Week 26 and Week 52
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 26 and Week 52
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Asthma Control Questionnaire (ACQ) and Asthma Control Questionnaire-7 (QAC-7) are defined in the description of Outcome measure 10 above. An ACQ-7 response was defined as change from baseline (Week 0, pre-dose) in ACQ-7 score ≤ -0.5; non-response was defined as change from baseline in ACQ-7 score >-0.5 or missing data. Results represent the responders (i.e. change from baseline in ACQ-7 Score ≤ -0.5) at Week 26 and Week 52. |
Week 0 (pre-treatment, baseline) to Week 26 and Week 52
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12a_Change From Baseline in Average Morning PEF (L/Min) Over 52 Weeks of Treatment
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
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Change from baseline in average MORNING PEF (L/min) over 52 weeks of treatment. PEF=Peak expiratory flow; is the volume of air forcefully expelled from the lungs in one quick exhalation. |
Week 0 (pre-treatment, baseline) to Week 52.
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12b_Change From Baseline in Average Evening PEF (L/Min) Over 26 and 52 Weeks of Treatment
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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Change from baseline in average EVENING PEF (L/min) over 26 and 52 weeks of treatment. PEF=Peak expiratory flow; is the volume of air forcefully expelled from the lungs in one quick exhalation. |
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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13_Number of Patients at Risk of Moderate or Severe Asthma Exacerbation Over 52 Weeks
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
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Data were analysed for the number of patients at risk of a moderate or severe asthma exacerbation. Results show the number of patients who had moderate or severe asthma exacerbation over the 52 weeks treatment period. |
Week 0 (pre-treatment, baseline) to Week 52.
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14_Number of Patients at Risk of Severe Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
Временное ограничение: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
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Data were analysed for the number of patients at risk of a severe asthma exacerbation in the pooled analysis of the two pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER). Results show the number of patients who had a severe asthma exacerbation over the 52 weeks treatment period. The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
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15_Moderate Asthma Exacerbation Rate Over the 52-Week Treatment Period in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 and CCD-055993AB2-02.
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
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Moderate asthma exacerbation rate over the 52-Week treatment period in the pooled analysis of the 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-055993AB2-02 (TRIGGER). The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
Week 0 (pre-treatment, baseline) to Week 52.
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16_Number of Patients at Risk of MODERATE Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
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Number of Patients at Risk of MODERATE Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02. The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
Week 0 (pre-treatment, baseline) to Week 52.
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17_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 and CCD-055993AB2-02
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
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Moderate and severe asthma exacerbation rate over the 52-Week treatment period in the pooled analysis of the 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER). Results show the number of participants with moderate and severe asthma exacerbation. The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
Week 0 (pre-treatment, baseline) to Week 52.
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18_Number of Patients at Risk of Moderate OR Severe Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
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Time to first moderate or severe asthma exacerbation in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER). Results show the number of participants with moderate or severe asthma exacerbation. The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
Week 0 (pre-treatment, baseline) to Week 52.
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19_Moderate Asthma Exacerbation Rate Over the 52-Week Treatment Period
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
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Moderate asthma exacerbation rate over the 52-Week treatment period.
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Week 0 (pre-treatment, baseline) to Week 52.
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21a_Change From Baseline in the Average Use of Rescue Medication Over the 26- and 52-Week Treatment Periods
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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Change from baseline in the average use of rescue medication over the 26- and 52-Week treatment periods. Data was collected through an electronic daily diary from screening to the end of the study. |
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
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21b_Change From Baseline in the Average Use of Rescue Medication in Each Inter-Visit Period
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
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Results show the change from baseline in the average use (puffs/day) of rescue medication in each inter-visit period. Data was collected through an electronic daily diary from screening to the end of the study. |
Week 0 (pre-treatment, baseline) to Week 52.
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22a_Change From Baseline in the Percentage of Rescue Medication-Free Days Over the 26- and 52-Week Treatment Periods
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
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Change from baseline in the percentage of rescue medication-free days in each inter-visit period over the 26- and 52-Week treatment periods. Data was collected through an electronic daily diary from screening to the end of the study. |
Week 0 (pre-treatment, baseline) to Week 52.
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22b_Change From Baseline in the Percentage of Rescue Medication-Free Days in Each Inter-Visit Period Over the Treatment
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
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Results show the change from baseline in the percentage of rescue medication-free days in each inter-visit period over the entire treatment. Data was collected through an electronic daily diary from screening to the end of the study. |
Week 0 (pre-treatment, baseline) to Week 52.
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23a_Change From Baseline in the Average Daily Asthma Symptom Scores Over the 26- and 52-Week Treatment Periods
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
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Data was collected through an electronic daily diary from screening to the end of the study. Results show the change from baseline in the average daily asthma symptom scores over the 26- and 52-Weeks of treatment. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day. Symptoms considered: cough, wheeze, chest tightness, breathlessness.
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Week 0 (pre-treatment, baseline) to Week 52.
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23b_Change From Baseline in the Average Daily Asthma Symptom Scores in Each Inter-Visit Period
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
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Results show the change from baseline in the average daily asthma symptom scores in each inter-visit period over the entire treatment. Data was collected daily through an electronic diary from screening to the end of the study. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day. Symptoms considered: cough, wheeze, chest tightness, breathlessness.
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Week 0 (pre-treatment, baseline) to Week 52.
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24a_Change From Baseline in the Percentage of Asthma Symptom-Free Days Over the 26- and 52-Week Treatment Periods
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
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Change from baseline in the percentage of asthma symptom-free days over the 26- and 52-Week treatment periods. Data was collected through an electronic daily diary from screening to the end of the study. Results show the change from baseline in the average daily asthma symptom scores over the 26- and 52-Week treatment periods. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day. Symptoms considered by the questionnaire: cough, wheeze, chest tightness, breathlessness. An asthma symptom-free day is a day with total daily asthma symptom score = 0. For a description of the score see outcome measure number 23. |
Week 0 (pre-treatment, baseline) to Week 52.
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24b_Change From Baseline in the Percentage of Asthma Symptom-Free Days in Each Inter-Visit Periods
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
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Results show the change from baseline in the percentage of asthma symptom-free days in each inter-visit periods over the entire treatment. Data was collected through an electronic daily diary from screening to end of the study. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day. Symptoms considered by the questionnaire: cough, wheeze, chest tightness, breathlessness. An asthma symptom-free day is a day with total daily asthma symptom score = 0. For a description of the score see outcome measure number 23. |
Week 0 (pre-treatment, baseline) to Week 52.
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25a_Change From Baseline in the Percentage of Asthma Control Days Over the 26- and 52-Week Treatment Periods
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
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Results show the change from baseline in the percentage of asthma control days over the 26- and 52-Week treatment periods. Data was collected through an electronic daily diary from screening to the end of the study. Scoring of asthma symptoms (overall symptoms, cough, wheeze, chest tightness and breathlessness): Morning (night-time asthma symptoms): 0 (no symptoms), 1 (mild - symptoms not causing awakening), 2 (moderate - discomfort enough to cause awakenings) and 3 (severe - causing awakenings for most of the night/did not sleep at all). Evening (daytime asthma symptoms): 0 (no symptoms), 1 (mild: aware of symptoms that could be easily tolerated), 2 (moderate: discomfort enough to cause interference with daily activity), 3 (severe: incapacitating with inability to work/take part in usual activity). |
Week 0 (pre-treatment, baseline) to Week 52.
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25b_Change From Baseline in the Percentage of Asthma Control Days in Each Inter-Visit Period
Временное ограничение: Week 0 (pre-treatment, baseline) to Week 52.
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Results show the change from baseline in the percentage of asthma control days in each inter-visit period. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day. Data was collected through an electronic daily diary from screening to the end of the study Scoring of asthma symptoms (overall symptoms, cough, wheeze, chest tightness and breathlessness): Morning (night-time asthma symptoms): 0 (no symptoms), 1 (mild - symptoms not causing awakening), 2 (moderate - discomfort enough to cause awakenings) and 3 (severe - causing awakenings for most of the night/did not sleep at all). Evening (daytime asthma symptoms): 0 (no symptoms), 1 (mild: aware of symptoms that could be easily tolerated), 2 (moderate: discomfort enough to cause interference with daily activity), 3 (severe: incapacitating with inability to work/take part in usual activity). |
Week 0 (pre-treatment, baseline) to Week 52.
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Побочные явления и нежелательные реакции на лекарства
Временное ограничение: До 52 недели
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До 52 недели
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Сборник результатов экономики здравоохранения
Временное ограничение: С 0 по 52 неделю
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Общее использование ресурсов здравоохранения и отсутствие на работе
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С 0 по 52 неделю
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Christian Virchow, MD, Facharzt für Innere Medizin Rostock, Germany
Публикации и полезные ссылки
Общие публикации
- Virchow JC, Kuna P, Paggiaro P, Papi A, Singh D, Corre S, Zuccaro F, Vele A, Kots M, Georges G, Petruzzelli S, Canonica GW. Single inhaler extrafine triple therapy in uncontrolled asthma (TRIMARAN and TRIGGER): two double-blind, parallel-group, randomised, controlled phase 3 trials. Lancet. 2019 Nov 9;394(10210):1737-1749. doi: 10.1016/S0140-6736(19)32215-9. Epub 2019 Sep 30.
- Orlovic M, Magni T, Lukyanov V, Guerra I, Madoni A. Cost-effectiveness of single-inhaler extrafine beclometasone dipropionate/formoterol fumarate/glycopyrronium in patients with uncontrolled asthma in England. Respir Med. 2022 Sep;201:106934. doi: 10.1016/j.rmed.2022.106934. Epub 2022 Jul 19.
- Papi A, Singh D, Virchow JC, Canonica GW, Vele A, Georges G. Normalisation of airflow limitation in asthma: Post-hoc analyses of TRIMARAN and TRIGGER. Clin Transl Allergy. 2022 Apr 17;12(4):e12145. doi: 10.1002/clt2.12145. eCollection 2022 Apr.
- Singh D, Virchow JC, Canonica GW, Vele A, Kots M, Georges G, Papi A. Determinants of response to inhaled extrafine triple therapy in asthma: analyses of TRIMARAN and TRIGGER. Respir Res. 2020 Oct 29;21(1):285. doi: 10.1186/s12931-020-01558-y.
- Singh D, Virchow JC, Canonica GW, Vele A, Kots M, Georges G, Papi A. Extrafine triple therapy in patients with asthma and persistent airflow limitation. Eur Respir J. 2020 Sep 24;56(3):2000476. doi: 10.1183/13993003.00476-2020. Print 2020 Sep. No abstract available.
- Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
Полезные ссылки
- Study Record on EU Clinical Trials Register including results.
- Study Record on EU Clinical Trials Register including results. Study CCD-05993AB2-02; TRIGGER;
- TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA (TRIMARAN) ClinicalTrials.gov ID NCT02676076
- Time course of exacerbation reduction with extrafine beclomethasone dipropionate, formoterol fumarate, and glycopyrronium bromide (BDP/FF/GB) pMDI in adults with moderate to severe asthma: A post-hoc analysis of the TRIMARAN and TRIGGER Studies
- TRIple in Asthma hiGh strenGth vErsus Ics/ Laba hs and tiotRopium (TRIGGER)
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 (Оцененный)
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
- CCD-05993AB1-03
- 2015-000716-18 (Номер EudraCT)
Планирование данных отдельных участников (IPD)
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Описание плана IPD
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Критерии совместного доступа к IPD
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