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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 de novembro de 2016 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

2508

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

12 anos a 75 anos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Benralizumabe 30 mg a cada 4 semanas
Benralizumabe administrado por via subcutânea a cada 4 semanas
Biológico: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Experimental: Benralizumabe 30 mg a cada 8 semanas
Benralizumabe administrado por via subcutânea a cada 8 semanas
Biológico: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Comparador de Placebo: Placebo
Placebo administrado por via subcutânea
Biológico: Placebo
Placebo subcutaneously on study week 0 until study week 52 inclusive.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

AstraZeneca

Investigadores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de agosto de 2013

Conclusão Primária (Real)

1 de março de 2016

Conclusão do estudo (Real)

1 de março de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

31 de julho de 2013

Enviado pela primeira vez que atendeu aos critérios de CQ

31 de julho de 2013

Primeira postagem (Estimativa)

2 de agosto de 2013

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

25 de janeiro de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de novembro de 2016

Última verificação

1 de novembro de 2016

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • D3250C00018

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