이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2016년 11월 30일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

2508

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

12년 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 벤랄리주맙 30mg q.4주
Benralizumab은 4주마다 피하 투여
생물학적: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
실험적: 벤랄리주맙 30mg q.8주
Benralizumab은 8주마다 피하 투여
생물학적: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
위약 비교기: 위약
위약 피하 투여
생물학적: Placebo
Placebo subcutaneously on study week 0 until study week 52 inclusive.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AstraZeneca

수사관

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

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연구 주요 날짜

연구 시작

2013년 8월 1일

기본 완료 (실제)

2016년 3월 1일

연구 완료 (실제)

2016년 3월 1일

연구 등록 날짜

최초 제출

2013년 7월 31일

QC 기준을 충족하는 최초 제출

2013년 7월 31일

처음 게시됨 (추정)

2013년 8월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2017년 1월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 11월 30일

마지막으로 확인됨

2016년 11월 1일

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추가 관련 MeSH 약관

기타 연구 ID 번호

  • D3250C00018

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