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

2016年11月30日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

2508

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

12年～75年 (子、大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：ベンラリズマブ 30 mg 4 週間ごと
ベンラリズマブを4週間ごとに皮下投与
生物学的：Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
実験的：ベンラリズマブ 30 mg 8 週間ごと
ベンラリズマブを8週間ごとに皮下投与
生物学的：Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
プラセボコンパレーター：プラセボ
プラセボを皮下投与
生物学的：Placebo
Placebo subcutaneously on study week 0 until study week 52 inclusive.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

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スポンサー

AstraZeneca

捜査官

  • 主任研究者：Mark Fitzgerald, MD, PhD, Professor of Medicine、The Lung Centre, Gordon and Leslie Diamond Health Care Centre, Vancouver Canada

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2013年8月1日

一次修了 (実際)

2016年3月1日

研究の完了 (実際)

2016年3月1日

試験登録日

最初に提出

2013年7月31日

QC基準を満たした最初の提出物

2013年7月31日

最初の投稿 (見積もり)

2013年8月2日

学習記録の更新

投稿された最後の更新 (見積もり)

2017年1月25日

QC基準を満たした最後の更新が送信されました

2016年11月30日

最終確認日

2016年11月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • D3250C00018

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