- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01227278
A Study to Evaluate the Effectiveness of MEDI-563 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
11. srpna 2016 aktualizováno: MedImmune LLC
A Phase 2a, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI-563 in Subjects With Moderate-to-severe Chronic Obstructive Pulmonary Disease and Sputum Eosinophilia
To evaluate the effect of the drug in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) in Adults.
Přehled studie
Postavení
Dokončeno
Intervence / Léčba
Detailní popis
To evaluate the effect of multiple subcutaneous (SC) doses of benralizumab (MEDI 563) on the rate of moderate-to-severe annualized incidence rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult subjects with moderate-to-severe COPD who exhibit eosinophilia (greater than or equal to [>=] 3.0 percent [%] sputum eosinophilia in the previous 12 months or at Screening) in sputum compared to placebo.
Typ studie
Intervenční
Zápis (Aktuální)
421
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Hellerup, Dánsko
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København NV, Dánsko
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Odense C, Dánsko
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Århus C, Dánsko
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Quebec, Kanada
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Alberta
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Calgary, Alberta, Kanada
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Ontario
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Hamilton, Ontario, Kanada
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Saskatchewan
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Saskatoon, Saskatchewan, Kanada
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Frankfurt, Německo
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Mainz, Německo
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Gdańsk, Polsko
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Kraków, Polsko
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Warszawa, Polsko
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Łódź, Polsko
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Cambridge, Spojené království
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Edinburgh, Spojené království
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Leicester, Spojené království
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Manchester, Spojené království
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California
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Los Angeles, California, Spojené státy
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Georgia
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Marietta, Georgia, Spojené státy
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Illinois
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Normal, Illinois, Spojené státy
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New York
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Brooklyn, New York, Spojené státy
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy
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South Carolina
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Greenville, South Carolina, Spojené státy
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Texas
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Boerne, Texas, Spojené státy
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Tyler, Texas, Spojené státy
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Virginia
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Richmond, Virginia, Spojené státy
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Barcelona, Španělsko
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Lérida, Španělsko
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Málaga, Španělsko
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Oviedo, Španělsko
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
40 let až 85 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Subjects aged 40-85 years at the time of Screening
- Written informed consent obtained from the subject prior to performing any protocol related procedures
- Documented history of 1 or more Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
- Current smoker or ex-smoker with a tobacco history of greater than or equal to (>=) 10 pack-years
- Adequate contraception from screening through end of trial
- Able to read and write.
Exclusion Criteria:
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
- Pregnant, breastfeeding, or lactating women
- Known history of allergy or reaction to any component of the investigational product formulation
- History of anaphylaxis to any other biologic therapy
- Donation or transfusion of blood, plasma or platelets within the past 3 months prior to Screening
- Other significant pulmonary disease which in the opinion of the investigator or medical monitor, might compromise the interpretation of the study
- Fever greater than (>) 37.0 degree Centigrade (98.6 degree Fahrenheit) at Screening
- Receipt of any novel investigational medicinal product within 3 months before the first dose of investigational product in this study and through the end of the study
- Seropositive for hepatitis A, hepatitis B surface antigen, hepatitis C, or human immunodeficiency virus 1or 2 (HIV-1 or HIV 2)
- History of alcohol or drug abuse within the past year that required treatment that the investigator felt or medical monitor felt would compromise the study data interpretation
- Past or current malignancy within the past 5 years except adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than 1 year prior to Screening
- Subjects participating in, or scheduled for, an intensive COPD rehabilitation program (subjects who are in the maintenance phase of a rehabilitation program are eligible to take part)
- Current diagnosis of asthma according to Global Initiative for Asthma guidelines
- Previous treatment with MEDI-563.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Komparátor placeba: Placebo
Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
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Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
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Experimentální: Benralizumab 100 mg
Benralizumab (MEDI-563) 100 mg injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
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Benralizumab (MEDI-563) 100 mg injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Časové okno: Day 1 up to 393
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An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days.
Annualized Incidence Rate of Moderate or Severe AECOPD was assessed based on AECOPD data up to Day 393 (Rate = total number of moderate or severe AECOPD in each group/total person-year follow-up in each group).
The severity of an exacerbation of COPD is defined as: a) Mild exacerbations, which require treatment with an increase in usual therapy, example (eg), increase use of short acting bronchodilators, b) Moderate exacerbations which require treatment with systemic corticosteroids, and or antibiotics and c) Severe exacerbations which require hospitalization.
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Day 1 up to 393
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Časové okno: Day 1 up to 561
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An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent are events between administration of study drug and up to Day 561 that were absent before treatment or that worsened relative to pre-treatment state.
TEAEs reported below included both SAEs and non-serious AEs.
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Day 1 up to 561
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Number of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Časové okno: Day 1 up to 393
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An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days.
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Day 1 up to 393
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Percentage of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Časové okno: Day 1 up to 393
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An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days.
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Day 1 up to 393
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Annual Incidence Rate of Hospitalization Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Časové okno: Day 1 up to 393
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An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days.
Annualized Incidence Rate of hospitalization due to AECOPD was calculated as Rate = total number of hospitalizations/ total person years.
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Day 1 up to 393
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Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Domain Scores at Day 393
Časové okno: Baseline, Day 393
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The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease).
Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100.
The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status.
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Baseline, Day 393
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Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score
Časové okno: Day 393
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SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease).
Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100.
The total score and domain score were derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status.
Percentage of participants with 4-point, 8-point and 12-point change from baseline in SGRQ-C total score were observed.
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Day 393
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Change From Baseline in Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Domain Scores at Day 393
Časové okno: Baseline, Day 393
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The CRQ-SAS is a self-administered questionnaire which consist of 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items).
Participants rated their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment).
Individual items were equally weighted, and domain scores were calculated as the mean of all items within each domain; domain score range: 1 (maximum impairment) to 7 (no impairment).
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Baseline, Day 393
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Percentage of Participants With a 0.5-Point Improvement in Chronic Respiratory Questionnaire Self-administered Standardized Format (CRQ-SAS) Domain Scores at Day 393
Časové okno: Day 393
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The CRQ-SAS is a self-administered questionnaire which consist of 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items).
Participants rated their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment).
Individual items were equally weighted, and domain scores were calculated as the mean of all items within each domain; domain score range: 1 (maximum impairment) to 7 (no impairment).
Participants with 0.5 point improvement from baseline in the domain scores were observed.
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Day 393
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Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Scores at Day 393
Časové okno: Baseline, Day 393
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The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test.
The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe ).
BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD).
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Baseline, Day 393
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Rene van der Merwe, MBChB, MedImmune Ltd
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Sridhar S, Liu H, Pham TH, Damera G, Newbold P. Modulation of blood inflammatory markers by benralizumab in patients with eosinophilic airway diseases. Respir Res. 2019 Jan 18;20(1):14. doi: 10.1186/s12931-018-0968-8.
- Brightling CE, Bleecker ER, Panettieri RA Jr, Bafadhel M, She D, Ward CK, Xu X, Birrell C, van der Merwe R. Benralizumab for chronic obstructive pulmonary disease and sputum eosinophilia: a randomised, double-blind, placebo-controlled, phase 2a study. Lancet Respir Med. 2014 Nov;2(11):891-901. doi: 10.1016/S2213-2600(14)70187-0. Epub 2014 Sep 7.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. listopadu 2010
Primární dokončení (Aktuální)
1. ledna 2013
Dokončení studie (Aktuální)
1. července 2013
Termíny zápisu do studia
První předloženo
21. října 2010
První předloženo, které splnilo kritéria kontroly kvality
22. října 2010
První zveřejněno (Odhad)
25. října 2010
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
5. října 2016
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
11. srpna 2016
Naposledy ověřeno
1. března 2015
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- MI-CP196
- 2010-020127-52 (Číslo EudraCT)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .