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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 novembre 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

2508

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • 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
  • Canada
      • Quebec, Canada
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
      • Sherwood Park, Alberta, Canada
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Research Site
    • New Brunswick
      • Moncton, New Brunswick, Canada
        • Research Site
    • Ontario
      • Burlington, Ontario, Canada
        • Research Site
      • Hamilton, Ontario, Canada
        • Research Site
      • Ottawa, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site
      • St Charles Borromee, Quebec, Canada
        • 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
  • Filippine
      • Iloilo City, Filippine
        • Research Site
      • Lipa City, Filippine
        • Research Site
      • Quezon City, Filippine
        • Research Site
  • Germania
      • Aschaffenburg, Germania
        • Research Site
      • Bamberg, Germania
        • Research Site
      • Berlin, Germania
        • Research Site
      • Bonn, Germania
        • Research Site
      • Frankfurt, Germania
        • Research Site
      • Frankfurt/Main, Germania
        • Research Site
      • Geesthacht, Germania
        • Research Site
      • Gelsenkirchen, Germania
        • Research Site
      • Hamburg, Germania
        • Research Site
      • Hannover, Germania
        • Research Site
      • Herford, Germania
        • Research Site
      • Leipzig, Germania
        • Research Site
      • Mainz, Germania
        • Research Site
      • München, Germania
        • Research Site
      • Neu-Isenburg, Germania
        • Research Site
      • Rostock, Germania
        • Research Site
      • Rüdersdorf, Germania
        • Research Site
      • Witten, Germania
        • Research Site
  • Giappone
      • Asahi-shi, Giappone
        • Research Site
      • Chiyoda-ku, Giappone
        • Research Site
      • Chuo-ku, Giappone
        • Research Site
      • Fukuoka-shi, Giappone
        • Research Site
      • Himeji-shi, Giappone
        • Research Site
      • Hiroshima-shi, Giappone
        • Research Site
      • Itabashi-ku, Giappone
        • Research Site
      • Kagoshima-shi, Giappone
        • Research Site
      • Kishiwada-shi, Giappone
        • Research Site
      • Kobe-shi, Giappone
        • Research Site
      • Kokubunji-shi, Giappone
        • Research Site
      • Matsue-shi, Giappone
        • Research Site
      • Minato-ku, Giappone
        • Research Site
      • Mizunami-shi, Giappone
        • Research Site
      • Niigata-shi, Giappone
        • Research Site
      • Obihiro-shi, Giappone
        • Research Site
      • Oita-shi, Giappone
        • Research Site
      • Ota-shi, Giappone
        • Research Site
      • Sagamihara-shi, Giappone
        • Research Site
      • Sakai-shi, Giappone
        • Research Site
      • Sakaide-shi, Giappone
        • Research Site
      • Sapporo-shi, Giappone
        • Research Site
      • Sendai-shi, Giappone
        • Research Site
      • Setagaya-ku, Giappone
        • Research Site
      • Shibuya-ku, Giappone
        • Research Site
      • Shinagawa-ku, Giappone
        • Research Site
      • Sumida-ku, Giappone
        • Research Site
      • Takamatsu-shi, Giappone
        • Research Site
      • Toshima-ku, Giappone
        • Research Site
      • Tsukubo-gun, Giappone
        • Research Site
      • Yokohama-shi, Giappone
        • 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
  • Romania
      • Bragadiru, Romania
        • Research Site
      • Brasov, Romania
        • Research Site
      • Bucharest, Romania
        • Research Site
      • Constanta, Romania
        • Research Site
      • Deva, Romania
        • Research Site
      • Iasi, Romania
        • Research Site
      • Timisoara, Romania
        • Research Site
  • Stati Uniti
    • Alabama
      • Andalusia, Alabama, Stati Uniti
        • Research Site
      • Birmingham, Alabama, Stati Uniti
        • Research Site
    • Arizona
      • Flagstaff, Arizona, Stati Uniti
        • Research Site
      • Glendale, Arizona, Stati Uniti
        • Research Site
      • Phoenix, Arizona, Stati Uniti
        • Research Site
      • Tucson, Arizona, Stati Uniti
        • Research Site
    • California
      • Alhambra, California, Stati Uniti
        • Research Site
      • Anaheim, California, Stati Uniti
        • Research Site
      • Beverly Hills, California, Stati Uniti
        • Research Site
      • Garden Grove, California, Stati Uniti
        • Research Site
      • Lakewood, California, Stati Uniti
        • Research Site
      • North Hollywood, California, Stati Uniti
        • Research Site
      • Northridge, California, Stati Uniti
        • Research Site
      • Palmdale, California, Stati Uniti
        • Research Site
      • Rancho Mirage, California, Stati Uniti
        • Research Site
      • Redondo Beach, California, Stati Uniti
        • Research Site
      • Rolling Hills Estate, California, Stati Uniti
        • Research Site
      • Sacramento, California, Stati Uniti
        • Research Site
      • Stockton, California, Stati Uniti
        • Research Site
      • Thousand Oaks, California, Stati Uniti
        • Research Site
      • Upland, California, Stati Uniti
        • Research Site
      • Ventura, California, Stati Uniti
        • Research Site
      • Walnut Creek, California, Stati Uniti
        • Research Site
      • Westminister, California, Stati Uniti
        • Research Site
      • Woodland, California, Stati Uniti
        • Research Site
    • Colorado
      • Centennial, Colorado, Stati Uniti
        • Research Site
      • Colorado Springs, Colorado, Stati Uniti
        • Research Site
      • Wheat Ridge, Colorado, Stati Uniti
        • Research Site
    • Florida
      • Celebration, Florida, Stati Uniti
        • Research Site
      • Fort Lauderdale, Florida, Stati Uniti
        • Research Site
      • Hialeah, Florida, Stati Uniti
        • Research Site
      • Homestead, Florida, Stati Uniti
        • Research Site
      • Jacksonville, Florida, Stati Uniti
        • Research Site
      • Lehigh Acres, Florida, Stati Uniti
        • Research Site
      • Miami, Florida, Stati Uniti
        • Research Site
      • Ocala, Florida, Stati Uniti
        • Research Site
      • Orlando, Florida, Stati Uniti
        • Research Site
      • Ormond Beach, Florida, Stati Uniti
        • Research Site
      • Virginia Gardens, Florida, Stati Uniti
        • Research Site
    • Georgia
      • Gainesville, Georgia, Stati Uniti
        • Research Site
      • Smyrna, Georgia, Stati Uniti
        • Research Site
    • Idaho
      • Eagle, Idaho, Stati Uniti
        • Research Site
    • Illinois
      • Shiloh, Illinois, Stati Uniti
        • Research Site
    • Kansas
      • Lenexa, Kansas, Stati Uniti
        • Research Site
    • Kentucky
      • Fort Mitchell, Kentucky, Stati Uniti
        • Research Site
    • Louisiana
      • Covington, Louisiana, Stati Uniti
        • Research Site
    • Maine
      • Bangor, Maine, Stati Uniti
        • Research Site
    • Michigan
      • Farmington Hills, Michigan, Stati Uniti
        • Research Site
      • Flint, Michigan, Stati Uniti
        • Research Site
      • Traverse City, Michigan, Stati Uniti
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti
        • Research Site
    • Missouri
      • St Louis, Missouri, Stati Uniti
        • Research Site
    • Nevada
      • Las Vagas, Nevada, Stati Uniti
        • Research Site
    • New Jersey
      • Union, New Jersey, Stati Uniti
        • Research Site
    • New York
      • Bronx, New York, Stati Uniti
        • Research Site
    • North Carolina
      • Durham, North Carolina, Stati Uniti
        • Research Site
      • Wilmington, North Carolina, Stati Uniti
        • Research Site
    • Ohio
      • Cincinnati, Ohio, Stati Uniti
        • Research Site
      • Columbus, Ohio, Stati Uniti
        • Research Site
      • Dayton, Ohio, Stati Uniti
        • Research Site
      • Middleburg Heights, Ohio, Stati Uniti
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti
        • Research Site
    • Oregon
      • Corvallis, Oregon, Stati Uniti
        • Research Site
      • Portland, Oregon, Stati Uniti
        • Research Site
    • Pennsylvania
      • Jefferson Hills, Pennsylvania, Stati Uniti
        • Research Site
      • Pittsburgh, Pennsylvania, Stati Uniti
        • Research Site
    • South Carolina
      • Indian Land, South Carolina, Stati Uniti
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, Stati Uniti
        • Research Site
    • Tennessee
      • Knoxville, Tennessee, Stati Uniti
        • Research Site
    • Texas
      • Arlington, Texas, Stati Uniti
        • Research Site
      • Austin, Texas, Stati Uniti
        • Research Site
      • Boerne, Texas, Stati Uniti
        • Research Site
      • Dallas, Texas, Stati Uniti
        • Research Site
      • Houston, Texas, Stati Uniti
        • Research Site
      • San Antonio, Texas, Stati Uniti
        • Research Site
    • Utah
      • Midvale, Utah, Stati Uniti
        • Research Site
      • Murray, Utah, Stati Uniti
        • Research Site
    • Virginia
      • Fairfax, Virginia, Stati Uniti
        • Research Site
      • Falls Church, Virginia, Stati Uniti
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, Stati Uniti
        • Research Site
      • Milwaukee, Wisconsin, Stati Uniti
        • Research Site
  • Svezia
      • Goteborg, Svezia
        • Research Site
      • Luleå, Svezia
        • Research Site
      • Lund, Svezia
        • Research Site
  • Ucraina
      • Chernivtsi, Ucraina
        • Research Site
      • Dnipropetrovsk, Ucraina
        • Research Site
      • Ivano-Frankivsk, Ucraina
        • Research Site
      • Kharkiv, Ucraina
        • Research Site
      • Kyiv, Ucraina
        • Research Site
      • Lutsk, Ucraina
        • Research Site
      • Mykolayiv, Ucraina
        • Research Site
      • Uzhgorod, Ucraina
        • Research Site
      • Vinnytsia, Ucraina
        • Research Site
      • Vinnytsya, Ucraina
        • Research Site
      • Zaporizhzhia, Ucraina
        • Research Site
      • Zaporozhye, Ucraina
        • Research Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 12 anni a 75 anni (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Benralizumab 30 mg ogni 4 settimane
Benralizumab somministrato per via sottocutanea ogni 4 settimane
Biologico: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Sperimentale: Benralizumab 30 mg ogni 8 settimane
Benralizumab somministrato per via sottocutanea ogni 8 settimane
Biologico: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Comparatore placebo: Placebo
Placebo somministrato per via sottocutanea
Biologico: Placebo
Placebo subcutaneously on study week 0 until study week 52 inclusive.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AstraZeneca

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 agosto 2013

Completamento primario (Effettivo)

1 marzo 2016

Completamento dello studio (Effettivo)

1 marzo 2016

Date di iscrizione allo studio

Primo inviato

31 luglio 2013

Primo inviato che soddisfa i criteri di controllo qualità

31 luglio 2013

Primo Inserito (Stima)

2 agosto 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

25 gennaio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 novembre 2016

Ultimo verificato

1 novembre 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • D3250C00018

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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