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A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease (SPRING)

30 listopada 2016 zaktualizowane przez: MedImmune LLC

A Phase 2 Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease

The purpose of this study is to evaluate the effect of MEDI8968 on the rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult subjects with symptomatic, moderate to very severe COPD (Global Initiative for Chronic Obstructive Lung Disease - GOLD stage II-IV) receiving standard maintenance therapy for the underlying disease condition.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

A Phase 2 double-blind, placebo-controlled study to evaluate the efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease. The study will have a screening phase of 23 days, treatment phase from Week 1 to 53 and follow-up phase from Week 53 to 69. Participants will receive either MEDI8968 600 milligram (mg) as intravenous (IV) infusion on Day 1 followed by 300 mg injection subcutaneously (SC) every 4 weeks up to Week 53 or matching placebo in the same fashion. Participants will primarily be assessed for incidence rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Safety will be monitored throughout the study.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

464

Faza

  • Faza 2

Kontakty i lokalizacje

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

Lokalizacje studiów

  • Bułgaria
      • Plovdiv, Bułgaria
        • Research Site
      • Ruse, Bułgaria
        • Research Site
      • Sofia, Bułgaria
        • Research Site
      • Stara Zagora, Bułgaria
        • Research Site
      • Veliko Tarnovo, Bułgaria
        • Research Site
  • Filipiny
      • Iloilo City, Filipiny
        • Research Site
      • Lipa City, Filipiny
        • Research Site
      • Quezon City, Filipiny
        • Research Site
  • Litwa
      • Kaunas, Litwa
        • Research Site
      • Klaipeda, Litwa
        • Research Site
      • Vilnius, Litwa
        • Research Site
  • Polska
      • Bialystok, Polska
        • Research Site
      • Gdansk, Polska
        • Research Site
      • Krakow, Polska
        • Research Site
      • Lodz, Polska
        • Research Site
      • Oswiecim, Polska
        • Research Site
      • Poznan, Polska
        • Research Site
      • Wroclaw, Polska
        • Research Site
      • Zgierz, Polska
        • Research Site
  • Republika Czeska
      • Brno, Republika Czeska
        • Research Site
      • Jindrichuv Hradec, Republika Czeska
        • Research Site
      • Karlovy Vary, Republika Czeska
        • Research Site
      • Plzen, Republika Czeska
        • Research Site
      • Praha 10, Republika Czeska
        • Research Site
      • Strakonice, Republika Czeska
        • Research Site
  • Stany Zjednoczone
    • Arizona
      • Peoria, Arizona, Stany Zjednoczone
        • Research Site
    • Florida
      • Clearwater, Florida, Stany Zjednoczone
        • Research Site
    • Georgia
      • Duluth, Georgia, Stany Zjednoczone
        • Research Site
    • Maine
      • Auburn, Maine, Stany Zjednoczone
        • Research Site
    • New York
      • Buffalo, New York, Stany Zjednoczone
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, Stany Zjednoczone
        • Research Site
    • Ohio
      • Cincinnati, Ohio, Stany Zjednoczone
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Stany Zjednoczone
        • Research Site
    • South Carolina
      • Greenville, South Carolina, Stany Zjednoczone
        • Research Site
      • Spartanburg, South Carolina, Stany Zjednoczone
        • Research Site
    • Texas
      • Boerne, Texas, Stany Zjednoczone
        • Research Site
    • Virginia
      • Richmond, Virginia, Stany Zjednoczone
        • Research Site
  • Ukraina
      • Ivano-Frankivsk, Ukraina
        • Research Site
      • Kharkiv, Ukraina
        • Research Site
      • Kyiv, Ukraina
        • Research Site
      • Odessa, Ukraina
        • Research Site
      • Poltava, Ukraina
        • Research Site
      • Simferopol, Ukraina
        • Research Site
      • Vinnytsya, Ukraina
        • Research Site
  • Węgry
      • Balassagyarmat, Węgry
        • Research Site
      • Budapest, Węgry
        • Research Site
      • Farkasgyepü, Węgry
        • Research Site
      • Komarom, Węgry
        • Research Site
      • Mateszalka, Węgry
        • Research Site
      • Matrahaza, Węgry
        • Research Site
      • Mosonmagyarovar, Węgry
        • Research Site
      • Nagykanizsa, Węgry
        • Research Site
      • Szikszo, Węgry
        • Research Site
      • Tatabanya, Węgry
        • Research Site
      • Torokbalint, Węgry
        • Research Site
  • Zjednoczone Królestwo
      • Cambridge, Zjednoczone Królestwo
        • Research Site
      • Newcastle upon Tyne, Zjednoczone Królestwo
        • Research Site
      • Wolverhampton, Zjednoczone Królestwo
        • Research Site
  • Łotwa
      • Daugavpils, Łotwa
        • Research Site
      • Riga, Łotwa
        • Research Site

Kryteria uczestnictwa

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

Kryteria kwalifikacji

Wiek uprawniający do nauki

45 lat do 75 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Age 45 through 75 years
  • Predicted (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage II, III, and IV) at Screening
  • History of previous acute exacerbations of chronic obstructive pulmonary disease (AECOPD) 12 months prior to Screening
  • Clinically stable and free from an AECOPD for 8 weeks prior to Day 1
  • Current smoker or ex-smoker with a tobacco history of more than or equal to (>=) 10 pack-years.

Exclusion Criteria:

  • Past or present disease or disorder,
  • Significant or unstable ischemic heart disease etc
  • Known history of allergy or reaction to any component of the investigational manufacturing product (IMP)
  • Past or current malignancy within the past 5 years
  • Subjects have had a chest x-ray or Computed Tomography (CT) scan suggestive of malignancy or tuberculosis (TB).
  • Use of immunosuppressive medication receipt of any biologic agent.

Plan studiów

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

Jak projektuje się badanie?

Szczegóły projektu

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

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Placebo
Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53.
Inny: Placebo
Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53.
Eksperymentalny: MEDI8968 600 mg IV, 300 mg SC
MEDI8968 600 milligram (mg) as intravenous (IV) infusion on Day 1 followed by 300 mg injection subcutaneously (SC) every 4 weeks up to Week 53.
Biologiczny: MEDI8968 600 mg IV, 300 mg SC
MEDI8968 600 mg as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Mean Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Ramy czasowe: Day 1 up to 393
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. The severity of an AECOPD is defined as: Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year.
Day 1 up to 393

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Mean Rate of Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Ramy czasowe: Day 1 up to 393
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. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year.
Day 1 up to 393
Time to First Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Ramy czasowe: Day 1 up to 393
Time to first worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. The severity of an AECOPD is defined as: Mild exacerbations require treatment with an increase in usual therapy, e.g., increase use of short acting bronchodilators. Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization.
Day 1 up to 393
Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Subscales Scores at Week 53
Ramy czasowe: Baseline and Week 53
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.
Baseline and Week 53
Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score
Ramy czasowe: Week 53
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. A 4-point change in total score demonstrates a clinically meaningful change, while an 8-point change and a 12-point change are interpreted as a moderate and large change in health status, respectively.
Week 53
Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score at Week 53
Ramy czasowe: Baseline and Week 53
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).
Baseline and Week 53
Percentage of Participants With Improvement in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score
Ramy czasowe: Baseline and Week 53
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). Negative change score signifies improvement compared to baseline. Number of participants with improvement in BODE score compared to baseline were reported.
Baseline and Week 53
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Ramy czasowe: Day 1 up to Week 69
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 Week 69 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs reported below included both SAEs and non-serious AEs.
Day 1 up to Week 69
Observed Serum Concentrations of MEDI8968
Ramy czasowe: Pre-dose (Baseline), Post-dose on Week 53
Pre-dose (Baseline), Post-dose on Week 53
Number of Participants Exhibiting Anti-Drug Antibodies for MEDI8968 at Any Visit
Ramy czasowe: Day 1 up to Week 69
Anti-drug antibodies for MEDI8968 were analyzed for participants who received placebo or MEDI8968 as per planned analysis.
Day 1 up to Week 69

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

MedImmune LLC

Śledczy

  • Dyrektor Studium: Rene Van Der Merwe, MBChB, MFPM, MedImmune Ltd

Publikacje i pomocne linki

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

Publikacje ogólne

Daty zapisu na studia

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

Główne daty studiów

Rozpoczęcie studiów

1 listopada 2011

Zakończenie podstawowe (Rzeczywisty)

1 lutego 2014

Ukończenie studiów (Rzeczywisty)

1 lutego 2014

Daty rejestracji na studia

Pierwszy przesłany

6 października 2011

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 października 2011

Pierwszy wysłany (Oszacować)

7 października 2011

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

30 stycznia 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

30 listopada 2016

Ostatnia weryfikacja

1 listopada 2016

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CD-RI-MEDI8968-1103

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

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