- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01448850
A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease (SPRING)
30. November 2016 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
464
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Plovdiv, Bulgarien
- Research Site
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Ruse, Bulgarien
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Sofia, Bulgarien
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Stara Zagora, Bulgarien
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Veliko Tarnovo, Bulgarien
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Daugavpils, Lettland
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Riga, Lettland
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Kaunas, Litauen
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Klaipeda, Litauen
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Vilnius, Litauen
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Iloilo City, Philippinen
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Lipa City, Philippinen
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Quezon City, Philippinen
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Bialystok, Polen
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Gdansk, Polen
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Krakow, Polen
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Lodz, Polen
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Oswiecim, Polen
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Poznan, Polen
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Wroclaw, Polen
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Zgierz, Polen
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Brno, Tschechische Republik
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Jindrichuv Hradec, Tschechische Republik
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Karlovy Vary, Tschechische Republik
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Plzen, Tschechische Republik
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Praha 10, Tschechische Republik
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Strakonice, Tschechische Republik
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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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Balassagyarmat, Ungarn
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Budapest, Ungarn
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Farkasgyepü, Ungarn
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Komarom, Ungarn
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Mateszalka, Ungarn
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Matrahaza, Ungarn
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Mosonmagyarovar, Ungarn
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Nagykanizsa, Ungarn
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Szikszo, Ungarn
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Tatabanya, Ungarn
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Torokbalint, Ungarn
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Arizona
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Peoria, Arizona, Vereinigte Staaten
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Florida
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Clearwater, Florida, Vereinigte Staaten
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Georgia
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Duluth, Georgia, Vereinigte Staaten
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Maine
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Auburn, Maine, Vereinigte Staaten
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New York
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Buffalo, New York, Vereinigte Staaten
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North Carolina
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Charlotte, North Carolina, Vereinigte Staaten
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Ohio
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Cincinnati, Ohio, Vereinigte Staaten
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Oklahoma
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Oklahoma City, Oklahoma, Vereinigte Staaten
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South Carolina
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Greenville, South Carolina, Vereinigte Staaten
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Spartanburg, South Carolina, Vereinigte Staaten
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Texas
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Boerne, Texas, Vereinigte Staaten
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Virginia
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Richmond, Virginia, Vereinigte Staaten
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Cambridge, Vereinigtes Königreich
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Newcastle upon Tyne, Vereinigtes Königreich
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Wolverhampton, Vereinigtes Königreich
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
45 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Placebo-Komparator: 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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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Mean Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Mean Rate of Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: Rene Van Der Merwe, MBChB, MFPM, MedImmune Ltd
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. November 2011
Primärer Abschluss (Tatsächlich)
1. Februar 2014
Studienabschluss (Tatsächlich)
1. Februar 2014
Studienanmeldedaten
Zuerst eingereicht
6. Oktober 2011
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
6. Oktober 2011
Zuerst gepostet (Schätzen)
7. Oktober 2011
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
30. Januar 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
30. November 2016
Zuletzt verifiziert
1. November 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CD-RI-MEDI8968-1103
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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