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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 noviembre de 2016 actualizado 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

2508

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Aschaffenburg, Alemania
        • Research Site
      • Bamberg, Alemania
        • Research Site
      • Berlin, Alemania
        • Research Site
      • Bonn, Alemania
        • Research Site
      • Frankfurt, Alemania
        • Research Site
      • Frankfurt/Main, Alemania
        • Research Site
      • Geesthacht, Alemania
        • Research Site
      • Gelsenkirchen, Alemania
        • Research Site
      • Hamburg, Alemania
        • Research Site
      • Hannover, Alemania
        • Research Site
      • Herford, Alemania
        • Research Site
      • Leipzig, Alemania
        • Research Site
      • Mainz, Alemania
        • Research Site
      • München, Alemania
        • Research Site
      • Neu-Isenburg, Alemania
        • Research Site
      • Rostock, Alemania
        • Research Site
      • Rüdersdorf, Alemania
        • Research Site
      • Witten, Alemania
        • 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
  • Japón
      • Asahi-shi, Japón
        • Research Site
      • Chiyoda-ku, Japón
        • Research Site
      • Chuo-ku, Japón
        • Research Site
      • Fukuoka-shi, Japón
        • Research Site
      • Himeji-shi, Japón
        • Research Site
      • Hiroshima-shi, Japón
        • Research Site
      • Itabashi-ku, Japón
        • Research Site
      • Kagoshima-shi, Japón
        • Research Site
      • Kishiwada-shi, Japón
        • Research Site
      • Kobe-shi, Japón
        • Research Site
      • Kokubunji-shi, Japón
        • Research Site
      • Matsue-shi, Japón
        • Research Site
      • Minato-ku, Japón
        • Research Site
      • Mizunami-shi, Japón
        • Research Site
      • Niigata-shi, Japón
        • Research Site
      • Obihiro-shi, Japón
        • Research Site
      • Oita-shi, Japón
        • Research Site
      • Ota-shi, Japón
        • Research Site
      • Sagamihara-shi, Japón
        • Research Site
      • Sakai-shi, Japón
        • Research Site
      • Sakaide-shi, Japón
        • Research Site
      • Sapporo-shi, Japón
        • Research Site
      • Sendai-shi, Japón
        • Research Site
      • Setagaya-ku, Japón
        • Research Site
      • Shibuya-ku, Japón
        • Research Site
      • Shinagawa-ku, Japón
        • Research Site
      • Sumida-ku, Japón
        • Research Site
      • Takamatsu-shi, Japón
        • Research Site
      • Toshima-ku, Japón
        • Research Site
      • Tsukubo-gun, Japón
        • Research Site
      • Yokohama-shi, Japón
        • Research Site
  • Polonia
      • Aleksandrów Łódzki, Polonia
        • Research Site
      • Białystok, Polonia
        • Research Site
      • Bielsko Biala, Polonia
        • Research Site
      • Bydgoszcz, Polonia
        • Research Site
      • Bystra Śląska, Polonia
        • Research Site
      • Gdańsk, Polonia
        • Research Site
      • Gorzów Wlkp, Polonia
        • Research Site
      • Karczew, Polonia
        • Research Site
      • Katowice, Polonia
        • Research Site
      • Koszalin, Polonia
        • Research Site
      • Kraków, Polonia
        • Research Site
      • Lubin, Polonia
        • Research Site
      • Lublin, Polonia
        • Research Site
      • Ostrów Wielkopolski, Polonia
        • Research Site
      • Poznań, Polonia
        • Research Site
      • Ruda Slaska, Polonia
        • Research Site
      • Rzeszów, Polonia
        • Research Site
      • Skierniewice, Polonia
        • Research Site
      • Szczecin, Polonia
        • Research Site
      • Tarnów, Polonia
        • Research Site
      • Toruń, Polonia
        • Research Site
      • Trzebnica, Polonia
        • Research Site
      • Warszawa, Polonia
        • Research Site
      • Wieluń, Polonia
        • Research Site
      • Wroclaw, Polonia
        • Research Site
      • Wrocław, Polonia
        • Research Site
      • Zabrze, Polonia
        • Research Site
      • Łódź, Polonia
        • Research Site
      • Łęczna, Polonia
        • Research Site
      • Żnin, Polonia
        • Research Site
  • Rumania
      • Bragadiru, Rumania
        • Research Site
      • Brasov, Rumania
        • Research Site
      • Bucharest, Rumania
        • Research Site
      • Constanta, Rumania
        • Research Site
      • Deva, Rumania
        • Research Site
      • Iasi, Rumania
        • Research Site
      • Timisoara, Rumania
        • Research Site
  • Suecia
      • Goteborg, Suecia
        • Research Site
      • Luleå, Suecia
        • Research Site
      • Lund, Suecia
        • Research Site
  • Ucrania
      • Chernivtsi, Ucrania
        • Research Site
      • Dnipropetrovsk, Ucrania
        • Research Site
      • Ivano-Frankivsk, Ucrania
        • Research Site
      • Kharkiv, Ucrania
        • Research Site
      • Kyiv, Ucrania
        • Research Site
      • Lutsk, Ucrania
        • Research Site
      • Mykolayiv, Ucrania
        • Research Site
      • Uzhgorod, Ucrania
        • Research Site
      • Vinnytsia, Ucrania
        • Research Site
      • Vinnytsya, Ucrania
        • Research Site
      • Zaporizhzhia, Ucrania
        • Research Site
      • Zaporozhye, Ucrania
        • Research Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

12 años a 75 años (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Benralizumab 30 mg cada 4 semanas
Benralizumab administrado por vía subcutánea cada 4 semanas
Biológico: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Experimental: Benralizumab 30 mg cada 8 semanas
Benralizumab administrado por vía subcutánea cada 8 semanas
Biológico: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Comparador de placebos: Placebo
Placebo administrado por vía subcutánea
Biológico: Placebo
Placebo subcutaneously on study week 0 until study week 52 inclusive.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

AstraZeneca

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 2013

Finalización primaria (Actual)

1 de marzo de 2016

Finalización del estudio (Actual)

1 de marzo de 2016

Fechas de registro del estudio

Enviado por primera vez

31 de julio de 2013

Primero enviado que cumplió con los criterios de control de calidad

31 de julio de 2013

Publicado por primera vez (Estimar)

2 de agosto de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

25 de enero de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

30 de noviembre de 2016

Última verificación

1 de noviembre de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • D3250C00018

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