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Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist

30 ноября 2016 г. обновлено: AstraZeneca

A Multicentre, Randomized, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Asthmatic Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist (CALIMA)

The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without oral corticosteroids and additional asthma controllers.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

2508

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Аргентина
      • Buenos Aires, Аргентина
        • Research Site
      • Caba, Аргентина
        • Research Site
      • Ciudad Autónoma de Bs. As., Аргентина
        • Research Site
      • Ciudad de Buenos Aires, Аргентина
        • Research Site
      • Concepción del Uruguay, Аргентина
        • Research Site
      • Corrientes, Аргентина
        • Research Site
      • Córdoba, Аргентина
        • Research Site
      • Florida, Аргентина
        • Research Site
      • Godoy Cruz, Аргентина
        • Research Site
      • La Plata, Аргентина
        • Research Site
      • Mar del Plata, Аргентина
        • Research Site
      • Mendoza, Аргентина
        • Research Site
      • Ranelagh, Аргентина
        • Research Site
      • Rosario, Аргентина
        • Research Site
      • San Miguel de Tucuman, Аргентина
        • Research Site
  • Германия
      • Aschaffenburg, Германия
        • Research Site
      • Bamberg, Германия
        • Research Site
      • Berlin, Германия
        • Research Site
      • Bonn, Германия
        • Research Site
      • Frankfurt, Германия
        • Research Site
      • Frankfurt/Main, Германия
        • Research Site
      • Geesthacht, Германия
        • Research Site
      • Gelsenkirchen, Германия
        • Research Site
      • Hamburg, Германия
        • Research Site
      • Hannover, Германия
        • Research Site
      • Herford, Германия
        • Research Site
      • Leipzig, Германия
        • Research Site
      • Mainz, Германия
        • Research Site
      • München, Германия
        • Research Site
      • Neu-Isenburg, Германия
        • Research Site
      • Rostock, Германия
        • Research Site
      • Rüdersdorf, Германия
        • Research Site
      • Witten, Германия
        • Research Site
  • Канада
      • Quebec, Канада
        • Research Site
    • Alberta
      • Calgary, Alberta, Канада
        • Research Site
      • Sherwood Park, Alberta, Канада
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Канада
        • Research Site
    • New Brunswick
      • Moncton, New Brunswick, Канада
        • Research Site
    • Ontario
      • Burlington, Ontario, Канада
        • Research Site
      • Hamilton, Ontario, Канада
        • Research Site
      • Ottawa, Ontario, Канада
        • Research Site
      • Toronto, Ontario, Канада
        • Research Site
    • Quebec
      • Montreal, Quebec, Канада
        • Research Site
      • St Charles Borromee, Quebec, Канада
        • Research Site
  • Польша
      • Aleksandrów Łódzki, Польша
        • Research Site
      • Białystok, Польша
        • Research Site
      • Bielsko Biala, Польша
        • Research Site
      • Bydgoszcz, Польша
        • Research Site
      • Bystra Śląska, Польша
        • Research Site
      • Gdańsk, Польша
        • Research Site
      • Gorzów Wlkp, Польша
        • Research Site
      • Karczew, Польша
        • Research Site
      • Katowice, Польша
        • Research Site
      • Koszalin, Польша
        • Research Site
      • Kraków, Польша
        • Research Site
      • Lubin, Польша
        • Research Site
      • Lublin, Польша
        • Research Site
      • Ostrów Wielkopolski, Польша
        • Research Site
      • Poznań, Польша
        • Research Site
      • Ruda Slaska, Польша
        • Research Site
      • Rzeszów, Польша
        • Research Site
      • Skierniewice, Польша
        • Research Site
      • Szczecin, Польша
        • Research Site
      • Tarnów, Польша
        • Research Site
      • Toruń, Польша
        • Research Site
      • Trzebnica, Польша
        • Research Site
      • Warszawa, Польша
        • Research Site
      • Wieluń, Польша
        • Research Site
      • Wroclaw, Польша
        • Research Site
      • Wrocław, Польша
        • Research Site
      • Zabrze, Польша
        • Research Site
      • Łódź, Польша
        • Research Site
      • Łęczna, Польша
        • Research Site
      • Żnin, Польша
        • Research Site
  • Румыния
      • Bragadiru, Румыния
        • Research Site
      • Brasov, Румыния
        • Research Site
      • Bucharest, Румыния
        • Research Site
      • Constanta, Румыния
        • Research Site
      • Deva, Румыния
        • Research Site
      • Iasi, Румыния
        • Research Site
      • Timisoara, Румыния
        • Research Site
  • Соединенные Штаты
    • Alabama
      • Andalusia, Alabama, Соединенные Штаты
        • Research Site
      • Birmingham, Alabama, Соединенные Штаты
        • Research Site
    • Arizona
      • Flagstaff, Arizona, Соединенные Штаты
        • Research Site
      • Glendale, Arizona, Соединенные Штаты
        • Research Site
      • Phoenix, Arizona, Соединенные Штаты
        • Research Site
      • Tucson, Arizona, Соединенные Штаты
        • Research Site
    • California
      • Alhambra, California, Соединенные Штаты
        • Research Site
      • Anaheim, California, Соединенные Штаты
        • Research Site
      • Beverly Hills, California, Соединенные Штаты
        • Research Site
      • Garden Grove, California, Соединенные Штаты
        • Research Site
      • Lakewood, California, Соединенные Штаты
        • Research Site
      • North Hollywood, California, Соединенные Штаты
        • Research Site
      • Northridge, California, Соединенные Штаты
        • Research Site
      • Palmdale, California, Соединенные Штаты
        • Research Site
      • Rancho Mirage, California, Соединенные Штаты
        • Research Site
      • Redondo Beach, California, Соединенные Штаты
        • Research Site
      • Rolling Hills Estate, California, Соединенные Штаты
        • Research Site
      • Sacramento, California, Соединенные Штаты
        • Research Site
      • Stockton, California, Соединенные Штаты
        • Research Site
      • Thousand Oaks, California, Соединенные Штаты
        • Research Site
      • Upland, California, Соединенные Штаты
        • Research Site
      • Ventura, California, Соединенные Штаты
        • Research Site
      • Walnut Creek, California, Соединенные Штаты
        • Research Site
      • Westminister, California, Соединенные Штаты
        • Research Site
      • Woodland, California, Соединенные Штаты
        • Research Site
    • Colorado
      • Centennial, Colorado, Соединенные Штаты
        • Research Site
      • Colorado Springs, Colorado, Соединенные Штаты
        • Research Site
      • Wheat Ridge, Colorado, Соединенные Штаты
        • Research Site
    • Florida
      • Celebration, Florida, Соединенные Штаты
        • Research Site
      • Fort Lauderdale, Florida, Соединенные Штаты
        • Research Site
      • Hialeah, Florida, Соединенные Штаты
        • Research Site
      • Homestead, Florida, Соединенные Штаты
        • Research Site
      • Jacksonville, Florida, Соединенные Штаты
        • Research Site
      • Lehigh Acres, Florida, Соединенные Штаты
        • Research Site
      • Miami, Florida, Соединенные Штаты
        • Research Site
      • Ocala, Florida, Соединенные Штаты
        • Research Site
      • Orlando, Florida, Соединенные Штаты
        • Research Site
      • Ormond Beach, Florida, Соединенные Штаты
        • Research Site
      • Virginia Gardens, Florida, Соединенные Штаты
        • Research Site
    • Georgia
      • Gainesville, Georgia, Соединенные Штаты
        • Research Site
      • Smyrna, Georgia, Соединенные Штаты
        • Research Site
    • Idaho
      • Eagle, Idaho, Соединенные Штаты
        • Research Site
    • Illinois
      • Shiloh, Illinois, Соединенные Штаты
        • Research Site
    • Kansas
      • Lenexa, Kansas, Соединенные Штаты
        • Research Site
    • Kentucky
      • Fort Mitchell, Kentucky, Соединенные Штаты
        • Research Site
    • Louisiana
      • Covington, Louisiana, Соединенные Штаты
        • Research Site
    • Maine
      • Bangor, Maine, Соединенные Штаты
        • Research Site
    • Michigan
      • Farmington Hills, Michigan, Соединенные Штаты
        • Research Site
      • Flint, Michigan, Соединенные Штаты
        • Research Site
      • Traverse City, Michigan, Соединенные Штаты
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, Соединенные Штаты
        • Research Site
    • Missouri
      • St Louis, Missouri, Соединенные Штаты
        • Research Site
    • Nevada
      • Las Vagas, Nevada, Соединенные Штаты
        • Research Site
    • New Jersey
      • Union, New Jersey, Соединенные Штаты
        • Research Site
    • New York
      • Bronx, New York, Соединенные Штаты
        • Research Site
    • North Carolina
      • Durham, North Carolina, Соединенные Штаты
        • Research Site
      • Wilmington, North Carolina, Соединенные Штаты
        • Research Site
    • Ohio
      • Cincinnati, Ohio, Соединенные Штаты
        • Research Site
      • Columbus, Ohio, Соединенные Штаты
        • Research Site
      • Dayton, Ohio, Соединенные Штаты
        • Research Site
      • Middleburg Heights, Ohio, Соединенные Штаты
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Соединенные Штаты
        • Research Site
    • Oregon
      • Corvallis, Oregon, Соединенные Штаты
        • Research Site
      • Portland, Oregon, Соединенные Штаты
        • Research Site
    • Pennsylvania
      • Jefferson Hills, Pennsylvania, Соединенные Штаты
        • Research Site
      • Pittsburgh, Pennsylvania, Соединенные Штаты
        • Research Site
    • South Carolina
      • Indian Land, South Carolina, Соединенные Штаты
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, Соединенные Штаты
        • Research Site
    • Tennessee
      • Knoxville, Tennessee, Соединенные Штаты
        • Research Site
    • Texas
      • Arlington, Texas, Соединенные Штаты
        • Research Site
      • Austin, Texas, Соединенные Штаты
        • Research Site
      • Boerne, Texas, Соединенные Штаты
        • Research Site
      • Dallas, Texas, Соединенные Штаты
        • Research Site
      • Houston, Texas, Соединенные Штаты
        • Research Site
      • San Antonio, Texas, Соединенные Штаты
        • Research Site
    • Utah
      • Midvale, Utah, Соединенные Штаты
        • Research Site
      • Murray, Utah, Соединенные Штаты
        • Research Site
    • Virginia
      • Fairfax, Virginia, Соединенные Штаты
        • Research Site
      • Falls Church, Virginia, Соединенные Штаты
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, Соединенные Штаты
        • Research Site
      • Milwaukee, Wisconsin, Соединенные Штаты
        • Research Site
  • Украина
      • Chernivtsi, Украина
        • Research Site
      • Dnipropetrovsk, Украина
        • Research Site
      • Ivano-Frankivsk, Украина
        • Research Site
      • Kharkiv, Украина
        • Research Site
      • Kyiv, Украина
        • Research Site
      • Lutsk, Украина
        • Research Site
      • Mykolayiv, Украина
        • Research Site
      • Uzhgorod, Украина
        • Research Site
      • Vinnytsia, Украина
        • Research Site
      • Vinnytsya, Украина
        • Research Site
      • Zaporizhzhia, Украина
        • Research Site
      • Zaporozhye, Украина
        • Research Site
  • Филиппины
      • Iloilo City, Филиппины
        • Research Site
      • Lipa City, Филиппины
        • Research Site
      • Quezon City, Филиппины
        • Research Site
  • Чили
      • Concepcion, Чили
        • Research Site
      • Quillota, Чили
        • Research Site
      • Santiago, Чили
        • Research Site
      • Talcahuano, Чили
        • Research Site
      • Valparaiso, Чили
        • Research Site
      • Viña del Mar, Чили
        • Research Site
  • Швеция
      • Goteborg, Швеция
        • Research Site
      • Luleå, Швеция
        • Research Site
      • Lund, Швеция
        • Research Site
  • Япония
      • Asahi-shi, Япония
        • Research Site
      • Chiyoda-ku, Япония
        • Research Site
      • Chuo-ku, Япония
        • Research Site
      • Fukuoka-shi, Япония
        • Research Site
      • Himeji-shi, Япония
        • Research Site
      • Hiroshima-shi, Япония
        • Research Site
      • Itabashi-ku, Япония
        • Research Site
      • Kagoshima-shi, Япония
        • Research Site
      • Kishiwada-shi, Япония
        • Research Site
      • Kobe-shi, Япония
        • Research Site
      • Kokubunji-shi, Япония
        • Research Site
      • Matsue-shi, Япония
        • Research Site
      • Minato-ku, Япония
        • Research Site
      • Mizunami-shi, Япония
        • Research Site
      • Niigata-shi, Япония
        • Research Site
      • Obihiro-shi, Япония
        • Research Site
      • Oita-shi, Япония
        • Research Site
      • Ota-shi, Япония
        • Research Site
      • Sagamihara-shi, Япония
        • Research Site
      • Sakai-shi, Япония
        • Research Site
      • Sakaide-shi, Япония
        • Research Site
      • Sapporo-shi, Япония
        • Research Site
      • Sendai-shi, Япония
        • Research Site
      • Setagaya-ku, Япония
        • Research Site
      • Shibuya-ku, Япония
        • Research Site
      • Shinagawa-ku, Япония
        • Research Site
      • Sumida-ku, Япония
        • Research Site
      • Takamatsu-shi, Япония
        • Research Site
      • Toshima-ku, Япония
        • Research Site
      • Tsukubo-gun, Япония
        • Research Site
      • Yokohama-shi, Япония
        • Research Site

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 12 лет до 75 лет (Ребенок, Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  1. Provision of informed consent prior to any study specific procedures
  2. Female and male aged 12 to 75 years, inclusively, at the time of Visit 1
  3. History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (>250µg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1.
  4. Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers. The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. For ICS/LABA combination preparations, the mid-strength approved maintenance dose in the local country will meet this ICS criterion.

Exclusion criteria:

  1. Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome)

  2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:

    • Affect the safety of the patient throughout the study
    • Influence the findings of the studies or their interpretations
    • Impede the patient's ability to complete the entire duration of study
  3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
  4. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study

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: Параллельное назначение
  • Маскировка: Тройной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Бенрализумаб 30 мг каждые 4 недели
Бенрализумаб вводят подкожно каждые 4 недели.
Биологический: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Экспериментальный: Бенрализумаб 30 мг каждые 8 ​​недель
Бенрализумаб вводят подкожно каждые 8 ​​недель.
Биологический: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Плацебо Компаратор: Плацебо
Плацебо вводят подкожно
Биологический: Placebo
Placebo subcutaneously on study week 0 until study week 52 inclusive.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL
Временное ограничение: Immediately following the first administration of study drug through Study Week 56.
The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.
Immediately following the first administration of study drug through Study Week 56.

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL
Временное ограничение: Immediately following the first administration of study drug through Study Week 56.
The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils >=300/uL
Временное ограничение: Immediately following the first administration of study drug through Study Week 56.
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils <300/uL
Временное ограничение: Immediately following the first administration of study drug through Study Week 56.
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils >=300/uL
Временное ограничение: Immediately following the first administration of study drug through Study Week 56.
Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils <300/uL
Временное ограничение: Immediately following the first administration of study drug through Study Week 56.
Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.
Immediately following the first administration of study drug through Study Week 56.
Change in Asthma Rescue Medication Use
Временное ограничение: Immediately following the first administration of study drug through Study Week 56.
Change from Baseline to Week 56 in number of Rescue medication use (puffs/day)
Immediately following the first administration of study drug through Study Week 56.
Home Lung Function Assessments Based on PEF
Временное ограничение: Immediately following the first administration of study drug through Study Week 56.
Change from Baseline to Week 56 in Home lung function (morning and evening Peak expiratory flow [PEF])
Immediately following the first administration of study drug through Study Week 56.
Proportion of Nights With Awakening Due to Asthma
Временное ограничение: Immediately following the first administration of study drug through Study Week 56.
Change from Baseline to Week 56 on Proportion of Nights with awakening due to asthma
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils >=300/uL
Временное ограничение: Immediately following the first administration of study drug through Study Week 56.
ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils <300/uL
Временное ограничение: Immediately following the first administration of study drug through Study Week 56.
ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.
Immediately following the first administration of study drug through Study Week 56.
Number of Patients With >=1 Asthma Exacerbation
Временное ограничение: Immediately following the first administration of study drug through Study Week 56
Immediately following the first administration of study drug through Study Week 56
Time to First Asthma Exacerbation
Временное ограничение: Immediately following the first administration of study drug through Study Week 56
Immediately following the first administration of study drug through Study Week 56
Annual Rate of Asthma Exacerbation Resulting Emergency Room Visits and Hospitalizations
Временное ограничение: Immediately following the first administration of study drug through Study Week 56.
Annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalization (adjudicated)
Immediately following the first administration of study drug through Study Week 56.
Pharmacokinetics of Benralizumab
Временное ограничение: Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60
Mean PK Concentration at each visit
Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60
Immunogenicity of Benralizumab
Временное ограничение: Pre-treatment until end of follow-up
Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.
Pre-treatment until end of follow-up
Extent of Exposure
Временное ограничение: Immediately following the first administration of study drug through Study Week 56
Extent of exposure is defined as the duration of treatment in days
Immediately following the first administration of study drug through Study Week 56
Mean Change From Baseline to Week 56 in AQLQ(S)+12
Временное ограничение: Immediately following the first administration of study drug through Study Week 56
AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of >=0.5 are considered clinically meaningful.
Immediately following the first administration of study drug through Study Week 56
Change From Baseline to Week 56 in EQ-5D-5L VAS
Временное ограничение: Immediately following the first administration of study drug through Study Week 56
EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.
Immediately following the first administration of study drug through Study Week 56
Mean Work Productivity Loss Due to Asthma
Временное ограничение: Immediately following the first administration of study drug through Study Week 56
WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked. This is only applicable to patients who were employed.
Immediately following the first administration of study drug through Study Week 56
Mean Productivity Loss Due to Asthma in Classroom
Временное ограничение: Immediately following the first administration of study drug through Study Week 56
WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity. Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes. This is only applicable for patients who took classes.
Immediately following the first administration of study drug through Study Week 56
Number of Participants That Utilized Health Care Resources
Временное ограничение: Immediately following the first administration of study drug through Study Week 56
Immediately following the first administration of study drug through Study Week 56
Patient and Clinician Assessment of Response to Treatment
Временное ограничение: Immediately following the first administration of study drug through Study Week 56
CGIC (clinician global impression of change), and PGIC (patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using a 7-point rating scale, ranging from 1 (Very much Improved), to 7 (Very much Worse). This endpoint was added after the second protocol amendment, thus not all patients had data to be analyzed.
Immediately following the first administration of study drug through Study Week 56

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

AstraZeneca

Следователи

  • Главный следователь: Mark Fitzgerald, MD, PhD, Professor of Medicine, The Lung Centre, Gordon and Leslie Diamond Health Care Centre, Vancouver Canada

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

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

1 августа 2013 г.

Первичное завершение (Действительный)

1 марта 2016 г.

Завершение исследования (Действительный)

1 марта 2016 г.

Даты регистрации исследования

Первый отправленный

31 июля 2013 г.

Впервые представлено, что соответствует критериям контроля качества

31 июля 2013 г.

Первый опубликованный (Оценивать)

2 августа 2013 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

25 января 2017 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

30 ноября 2016 г.

Последняя проверка

1 ноября 2016 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • D3250C00018

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