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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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

2508

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Argentinië
      • Buenos Aires, Argentinië
        • Research Site
      • Caba, Argentinië
        • Research Site
      • Ciudad Autónoma de Bs. As., Argentinië
        • Research Site
      • Ciudad de Buenos Aires, Argentinië
        • Research Site
      • Concepción del Uruguay, Argentinië
        • Research Site
      • Corrientes, Argentinië
        • Research Site
      • Córdoba, Argentinië
        • Research Site
      • Florida, Argentinië
        • Research Site
      • Godoy Cruz, Argentinië
        • Research Site
      • La Plata, Argentinië
        • Research Site
      • Mar del Plata, Argentinië
        • Research Site
      • Mendoza, Argentinië
        • Research Site
      • Ranelagh, Argentinië
        • Research Site
      • Rosario, Argentinië
        • Research Site
      • San Miguel de Tucuman, Argentinië
        • 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
  • Chili
      • Concepcion, Chili
        • Research Site
      • Quillota, Chili
        • Research Site
      • Santiago, Chili
        • Research Site
      • Talcahuano, Chili
        • Research Site
      • Valparaiso, Chili
        • Research Site
      • Viña del Mar, Chili
        • Research Site
  • Duitsland
      • Aschaffenburg, Duitsland
        • Research Site
      • Bamberg, Duitsland
        • Research Site
      • Berlin, Duitsland
        • Research Site
      • Bonn, Duitsland
        • Research Site
      • Frankfurt, Duitsland
        • Research Site
      • Frankfurt/Main, Duitsland
        • Research Site
      • Geesthacht, Duitsland
        • Research Site
      • Gelsenkirchen, Duitsland
        • Research Site
      • Hamburg, Duitsland
        • Research Site
      • Hannover, Duitsland
        • Research Site
      • Herford, Duitsland
        • Research Site
      • Leipzig, Duitsland
        • Research Site
      • Mainz, Duitsland
        • Research Site
      • München, Duitsland
        • Research Site
      • Neu-Isenburg, Duitsland
        • Research Site
      • Rostock, Duitsland
        • Research Site
      • Rüdersdorf, Duitsland
        • Research Site
      • Witten, Duitsland
        • Research Site
  • Filippijnen
      • Iloilo City, Filippijnen
        • Research Site
      • Lipa City, Filippijnen
        • Research Site
      • Quezon City, Filippijnen
        • 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
  • Oekraïne
      • Chernivtsi, Oekraïne
        • Research Site
      • Dnipropetrovsk, Oekraïne
        • Research Site
      • Ivano-Frankivsk, Oekraïne
        • Research Site
      • Kharkiv, Oekraïne
        • Research Site
      • Kyiv, Oekraïne
        • Research Site
      • Lutsk, Oekraïne
        • Research Site
      • Mykolayiv, Oekraïne
        • Research Site
      • Uzhgorod, Oekraïne
        • Research Site
      • Vinnytsia, Oekraïne
        • Research Site
      • Vinnytsya, Oekraïne
        • Research Site
      • Zaporizhzhia, Oekraïne
        • Research Site
      • Zaporozhye, Oekraïne
        • 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
  • Roemenië
      • Bragadiru, Roemenië
        • Research Site
      • Brasov, Roemenië
        • Research Site
      • Bucharest, Roemenië
        • Research Site
      • Constanta, Roemenië
        • Research Site
      • Deva, Roemenië
        • Research Site
      • Iasi, Roemenië
        • Research Site
      • Timisoara, Roemenië
        • Research Site
  • Verenigde Staten
    • Alabama
      • Andalusia, Alabama, Verenigde Staten
        • Research Site
      • Birmingham, Alabama, Verenigde Staten
        • Research Site
    • Arizona
      • Flagstaff, Arizona, Verenigde Staten
        • Research Site
      • Glendale, Arizona, Verenigde Staten
        • Research Site
      • Phoenix, Arizona, Verenigde Staten
        • Research Site
      • Tucson, Arizona, Verenigde Staten
        • Research Site
    • California
      • Alhambra, California, Verenigde Staten
        • Research Site
      • Anaheim, California, Verenigde Staten
        • Research Site
      • Beverly Hills, California, Verenigde Staten
        • Research Site
      • Garden Grove, California, Verenigde Staten
        • Research Site
      • Lakewood, California, Verenigde Staten
        • Research Site
      • North Hollywood, California, Verenigde Staten
        • Research Site
      • Northridge, California, Verenigde Staten
        • Research Site
      • Palmdale, California, Verenigde Staten
        • Research Site
      • Rancho Mirage, California, Verenigde Staten
        • Research Site
      • Redondo Beach, California, Verenigde Staten
        • Research Site
      • Rolling Hills Estate, California, Verenigde Staten
        • Research Site
      • Sacramento, California, Verenigde Staten
        • Research Site
      • Stockton, California, Verenigde Staten
        • Research Site
      • Thousand Oaks, California, Verenigde Staten
        • Research Site
      • Upland, California, Verenigde Staten
        • Research Site
      • Ventura, California, Verenigde Staten
        • Research Site
      • Walnut Creek, California, Verenigde Staten
        • Research Site
      • Westminister, California, Verenigde Staten
        • Research Site
      • Woodland, California, Verenigde Staten
        • Research Site
    • Colorado
      • Centennial, Colorado, Verenigde Staten
        • Research Site
      • Colorado Springs, Colorado, Verenigde Staten
        • Research Site
      • Wheat Ridge, Colorado, Verenigde Staten
        • Research Site
    • Florida
      • Celebration, Florida, Verenigde Staten
        • Research Site
      • Fort Lauderdale, Florida, Verenigde Staten
        • Research Site
      • Hialeah, Florida, Verenigde Staten
        • Research Site
      • Homestead, Florida, Verenigde Staten
        • Research Site
      • Jacksonville, Florida, Verenigde Staten
        • Research Site
      • Lehigh Acres, Florida, Verenigde Staten
        • Research Site
      • Miami, Florida, Verenigde Staten
        • Research Site
      • Ocala, Florida, Verenigde Staten
        • Research Site
      • Orlando, Florida, Verenigde Staten
        • Research Site
      • Ormond Beach, Florida, Verenigde Staten
        • Research Site
      • Virginia Gardens, Florida, Verenigde Staten
        • Research Site
    • Georgia
      • Gainesville, Georgia, Verenigde Staten
        • Research Site
      • Smyrna, Georgia, Verenigde Staten
        • Research Site
    • Idaho
      • Eagle, Idaho, Verenigde Staten
        • Research Site
    • Illinois
      • Shiloh, Illinois, Verenigde Staten
        • Research Site
    • Kansas
      • Lenexa, Kansas, Verenigde Staten
        • Research Site
    • Kentucky
      • Fort Mitchell, Kentucky, Verenigde Staten
        • Research Site
    • Louisiana
      • Covington, Louisiana, Verenigde Staten
        • Research Site
    • Maine
      • Bangor, Maine, Verenigde Staten
        • Research Site
    • Michigan
      • Farmington Hills, Michigan, Verenigde Staten
        • Research Site
      • Flint, Michigan, Verenigde Staten
        • Research Site
      • Traverse City, Michigan, Verenigde Staten
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, Verenigde Staten
        • Research Site
    • Missouri
      • St Louis, Missouri, Verenigde Staten
        • Research Site
    • Nevada
      • Las Vagas, Nevada, Verenigde Staten
        • Research Site
    • New Jersey
      • Union, New Jersey, Verenigde Staten
        • Research Site
    • New York
      • Bronx, New York, Verenigde Staten
        • Research Site
    • North Carolina
      • Durham, North Carolina, Verenigde Staten
        • Research Site
      • Wilmington, North Carolina, Verenigde Staten
        • Research Site
    • Ohio
      • Cincinnati, Ohio, Verenigde Staten
        • Research Site
      • Columbus, Ohio, Verenigde Staten
        • Research Site
      • Dayton, Ohio, Verenigde Staten
        • Research Site
      • Middleburg Heights, Ohio, Verenigde Staten
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten
        • Research Site
    • Oregon
      • Corvallis, Oregon, Verenigde Staten
        • Research Site
      • Portland, Oregon, Verenigde Staten
        • Research Site
    • Pennsylvania
      • Jefferson Hills, Pennsylvania, Verenigde Staten
        • Research Site
      • Pittsburgh, Pennsylvania, Verenigde Staten
        • Research Site
    • South Carolina
      • Indian Land, South Carolina, Verenigde Staten
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, Verenigde Staten
        • Research Site
    • Tennessee
      • Knoxville, Tennessee, Verenigde Staten
        • Research Site
    • Texas
      • Arlington, Texas, Verenigde Staten
        • Research Site
      • Austin, Texas, Verenigde Staten
        • Research Site
      • Boerne, Texas, Verenigde Staten
        • Research Site
      • Dallas, Texas, Verenigde Staten
        • Research Site
      • Houston, Texas, Verenigde Staten
        • Research Site
      • San Antonio, Texas, Verenigde Staten
        • Research Site
    • Utah
      • Midvale, Utah, Verenigde Staten
        • Research Site
      • Murray, Utah, Verenigde Staten
        • Research Site
    • Virginia
      • Fairfax, Virginia, Verenigde Staten
        • Research Site
      • Falls Church, Virginia, Verenigde Staten
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, Verenigde Staten
        • Research Site
      • Milwaukee, Wisconsin, Verenigde Staten
        • Research Site
  • Zweden
      • Goteborg, Zweden
        • Research Site
      • Luleå, Zweden
        • Research Site
      • Lund, Zweden
        • Research Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

12 jaar tot 75 jaar (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Benralizumab 30 mg q.4 weken
Benralizumab elke 4 weken subcutaan toegediend
Biologisch: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Experimenteel: Benralizumab 30 mg q.8 weken
Benralizumab elke 8 weken subcutaan toegediend
Biologisch: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Placebo-vergelijker: Placebo
Placebo subcutaan toegediend
Biologisch: Placebo
Placebo subcutaneously on study week 0 until study week 52 inclusive.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

AstraZeneca

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 augustus 2013

Primaire voltooiing (Werkelijk)

1 maart 2016

Studie voltooiing (Werkelijk)

1 maart 2016

Studieregistratiedata

Eerst ingediend

31 juli 2013

Eerst ingediend dat voldeed aan de QC-criteria

31 juli 2013

Eerst geplaatst (Schatting)

2 augustus 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

25 januari 2017

Laatste update ingediend die voldeed aan QC-criteria

30 november 2016

Laatst geverifieerd

1 november 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • D3250C00018

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren