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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. November 2016 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

2508

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

12 Jahre bis 75 Jahre (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Benralizumab 30 mg alle 4 Wochen
Benralizumab wird alle 4 Wochen subkutan verabreicht
Biologisch: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Experimental: Benralizumab 30 mg alle 8 Wochen
Benralizumab wird alle 8 Wochen subkutan verabreicht
Biologisch: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Placebo-Komparator: Placebo
Placebo subkutan verabreicht
Biologisch: Placebo
Placebo subcutaneously on study week 0 until study week 52 inclusive.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

AstraZeneca

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. August 2013

Primärer Abschluss (Tatsächlich)

1. März 2016

Studienabschluss (Tatsächlich)

1. März 2016

Studienanmeldedaten

Zuerst eingereicht

31. Juli 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

31. Juli 2013

Zuerst gepostet (Schätzen)

2. August 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

25. Januar 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. November 2016

Zuletzt verifiziert

1. November 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • D3250C00018

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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