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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 listopada 2016 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

2508

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

12 lat do 75 lat (Dziecko, Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Benralizumab 30 mg co 4 tyg
Benralizumab podawany podskórnie co 4 tygodnie
Biologiczny: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Eksperymentalny: Benralizumab 30 mg co 8 tyg
Benralizumab podawany podskórnie co 8 tygodni
Biologiczny: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Komparator placebo: Placebo
Placebo podawane podskórnie
Biologiczny: Placebo
Placebo subcutaneously on study week 0 until study week 52 inclusive.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

AstraZeneca

Śledczy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 sierpnia 2013

Zakończenie podstawowe (Rzeczywisty)

1 marca 2016

Ukończenie studiów (Rzeczywisty)

1 marca 2016

Daty rejestracji na studia

Pierwszy przesłany

31 lipca 2013

Pierwszy przesłany, który spełnia kryteria kontroli jakości

31 lipca 2013

Pierwszy wysłany (Oszacować)

2 sierpnia 2013

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

25 stycznia 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

30 listopada 2016

Ostatnia weryfikacja

1 listopada 2016

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • D3250C00018

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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