A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease (SPRING)
30 novembre 2016 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
464
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Plovdiv, Bulgarie
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Ruse, Bulgarie
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Sofia, Bulgarie
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Stara Zagora, Bulgarie
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Veliko Tarnovo, Bulgarie
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Balassagyarmat, Hongrie
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Budapest, Hongrie
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Farkasgyepü, Hongrie
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Komarom, Hongrie
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Mateszalka, Hongrie
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Matrahaza, Hongrie
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Mosonmagyarovar, Hongrie
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Nagykanizsa, Hongrie
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Szikszo, Hongrie
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Tatabanya, Hongrie
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Torokbalint, Hongrie
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Daugavpils, Lettonie
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Riga, Lettonie
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Kaunas, Lituanie
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Klaipeda, Lituanie
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Vilnius, Lituanie
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Iloilo City, Philippines
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Lipa City, Philippines
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Quezon City, Philippines
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Bialystok, Pologne
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Gdansk, Pologne
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Krakow, Pologne
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Lodz, Pologne
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Oswiecim, Pologne
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Poznan, Pologne
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Wroclaw, Pologne
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Zgierz, Pologne
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Cambridge, Royaume-Uni
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Newcastle upon Tyne, Royaume-Uni
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Wolverhampton, Royaume-Uni
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Brno, République tchèque
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Jindrichuv Hradec, République tchèque
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Karlovy Vary, République tchèque
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Plzen, République tchèque
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Praha 10, République tchèque
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Strakonice, République tchèque
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Odessa, Ukraine
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Poltava, Ukraine
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Simferopol, Ukraine
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Vinnytsya, Ukraine
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Arizona
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Peoria, Arizona, États-Unis
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Florida
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Clearwater, Florida, États-Unis
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Georgia
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Duluth, Georgia, États-Unis
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Maine
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Auburn, Maine, États-Unis
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New York
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Buffalo, New York, États-Unis
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North Carolina
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Charlotte, North Carolina, États-Unis
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Ohio
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Cincinnati, Ohio, États-Unis
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis
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South Carolina
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Greenville, South Carolina, États-Unis
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Spartanburg, South Carolina, États-Unis
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Texas
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Boerne, Texas, États-Unis
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Virginia
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Richmond, Virginia, États-Unis
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
45 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur placebo: Placebo
Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53.
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Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53.
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Expérimental: 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.
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MEDI8968 600 mg as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Mean Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Délai: 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.
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.
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Day 1 up to 393
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Mean Rate of Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Délai: 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.
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.
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Day 1 up to 393
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Time to First Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Délai: Day 1 up to 393
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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.
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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 Subscales Scores at Week 53
Délai: Baseline and Week 53
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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 and Week 53
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Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score
Délai: Week 53
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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.
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.
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Week 53
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Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score at Week 53
Délai: Baseline and Week 53
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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 and Week 53
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Percentage of Participants With Improvement in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score
Délai: Baseline and Week 53
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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).
Negative change score signifies improvement compared to baseline.
Number of participants with improvement in BODE score compared to baseline were reported.
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Baseline and Week 53
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Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Délai: Day 1 up to Week 69
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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 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.
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Day 1 up to Week 69
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Observed Serum Concentrations of MEDI8968
Délai: Pre-dose (Baseline), Post-dose on Week 53
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Pre-dose (Baseline), Post-dose on Week 53
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Number of Participants Exhibiting Anti-Drug Antibodies for MEDI8968 at Any Visit
Délai: Day 1 up to Week 69
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Anti-drug antibodies for MEDI8968 were analyzed for participants who received placebo or MEDI8968 as per planned analysis.
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Day 1 up to Week 69
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Rene Van Der Merwe, MBChB, MFPM, MedImmune Ltd
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 novembre 2011
Achèvement primaire (Réel)
1 février 2014
Achèvement de l'étude (Réel)
1 février 2014
Dates d'inscription aux études
Première soumission
6 octobre 2011
Première soumission répondant aux critères de contrôle qualité
6 octobre 2011
Première publication (Estimation)
7 octobre 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
30 janvier 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 novembre 2016
Dernière vérification
1 novembre 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CD-RI-MEDI8968-1103
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .