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

2016년 11월 30일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

464

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 라트비아
      • Daugavpils, 라트비아
        • Research Site
      • Riga, 라트비아
        • Research Site
  • 리투아니아
      • Kaunas, 리투아니아
        • Research Site
      • Klaipeda, 리투아니아
        • Research Site
      • Vilnius, 리투아니아
        • Research Site
  • 미국
    • Arizona
      • Peoria, Arizona, 미국
        • Research Site
    • Florida
      • Clearwater, Florida, 미국
        • Research Site
    • Georgia
      • Duluth, Georgia, 미국
        • Research Site
    • Maine
      • Auburn, Maine, 미국
        • Research Site
    • New York
      • Buffalo, New York, 미국
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, 미국
        • Research Site
    • Ohio
      • Cincinnati, Ohio, 미국
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, 미국
        • Research Site
    • South Carolina
      • Greenville, South Carolina, 미국
        • Research Site
      • Spartanburg, South Carolina, 미국
        • Research Site
    • Texas
      • Boerne, Texas, 미국
        • Research Site
    • Virginia
      • Richmond, Virginia, 미국
        • Research Site
  • 불가리아
      • Plovdiv, 불가리아
        • Research Site
      • Ruse, 불가리아
        • Research Site
      • Sofia, 불가리아
        • Research Site
      • Stara Zagora, 불가리아
        • Research Site
      • Veliko Tarnovo, 불가리아
        • Research Site
  • 영국
      • Cambridge, 영국
        • Research Site
      • Newcastle upon Tyne, 영국
        • Research Site
      • Wolverhampton, 영국
        • Research Site
  • 우크라이나
      • Ivano-Frankivsk, 우크라이나
        • Research Site
      • Kharkiv, 우크라이나
        • Research Site
      • Kyiv, 우크라이나
        • Research Site
      • Odessa, 우크라이나
        • Research Site
      • Poltava, 우크라이나
        • Research Site
      • Simferopol, 우크라이나
        • Research Site
      • Vinnytsya, 우크라이나
        • Research Site
  • 체코 공화국
      • Brno, 체코 공화국
        • Research Site
      • Jindrichuv Hradec, 체코 공화국
        • Research Site
      • Karlovy Vary, 체코 공화국
        • Research Site
      • Plzen, 체코 공화국
        • Research Site
      • Praha 10, 체코 공화국
        • Research Site
      • Strakonice, 체코 공화국
        • Research Site
  • 폴란드
      • Bialystok, 폴란드
        • Research Site
      • Gdansk, 폴란드
        • Research Site
      • Krakow, 폴란드
        • Research Site
      • Lodz, 폴란드
        • Research Site
      • Oswiecim, 폴란드
        • Research Site
      • Poznan, 폴란드
        • Research Site
      • Wroclaw, 폴란드
        • Research Site
      • Zgierz, 폴란드
        • Research Site
  • 필리핀 제도
      • Iloilo City, 필리핀 제도
        • Research Site
      • Lipa City, 필리핀 제도
        • Research Site
      • Quezon City, 필리핀 제도
        • Research Site
  • 헝가리
      • Balassagyarmat, 헝가리
        • Research Site
      • Budapest, 헝가리
        • Research Site
      • Farkasgyepü, 헝가리
        • Research Site
      • Komarom, 헝가리
        • Research Site
      • Mateszalka, 헝가리
        • Research Site
      • Matrahaza, 헝가리
        • Research Site
      • Mosonmagyarovar, 헝가리
        • Research Site
      • Nagykanizsa, 헝가리
        • Research Site
      • Szikszo, 헝가리
        • Research Site
      • Tatabanya, 헝가리
        • Research Site
      • Torokbalint, 헝가리
        • Research Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

45년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: Placebo
Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53.
다른: Placebo
Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53.
실험적: 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.
생물학적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Mean Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Mean Rate of Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

MedImmune LLC

수사관

  • 연구 책임자: Rene Van Der Merwe, MBChB, MFPM, MedImmune Ltd

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2011년 11월 1일

기본 완료 (실제)

2014년 2월 1일

연구 완료 (실제)

2014년 2월 1일

연구 등록 날짜

최초 제출

2011년 10월 6일

QC 기준을 충족하는 최초 제출

2011년 10월 6일

처음 게시됨 (추정)

2011년 10월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2017년 1월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 11월 30일

마지막으로 확인됨

2016년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CD-RI-MEDI8968-1103

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Placebo에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

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정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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