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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 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

2508

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

12 år till 75 år (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Benralizumab 30 mg var 4 veckor
Benralizumab administreras subkutant var fjärde vecka
Biologisk: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Experimentell: Benralizumab 30 mg q.8 veckor
Benralizumab administreras subkutant var 8:e vecka
Biologisk: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Placebo-jämförare: Placebo
Placebo administreras subkutant
Biologisk: Placebo
Placebo subcutaneously on study week 0 until study week 52 inclusive.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AstraZeneca

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2013

Primärt slutförande (Faktisk)

1 mars 2016

Avslutad studie (Faktisk)

1 mars 2016

Studieregistreringsdatum

Först inskickad

31 juli 2013

Först inskickad som uppfyllde QC-kriterierna

31 juli 2013

Första postat (Uppskatta)

2 augusti 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

25 januari 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 november 2016

Senast verifierad

1 november 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • D3250C00018

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera