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A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (GOLDEN-2)

2018년 2월 6일 업데이트: Sunovion Respiratory Development Inc.

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of EP-101 (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease: GOLDEN-2 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer)

This is a randomized, double-blind, placebo-controlled, parallel arm study. The study population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

This is a randomized, double-blind, placebo-controlled, parallel arm study. The study population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011). The primary analysis will compare each of the EP-101 (SUN101) dose groups to placebo with respect to the change from baseline in morning trough FEV1 on Day 29. Trough FEV1 is defined as the mean of the two FEV1 values obtained at 23 hours 30 minutes and 24 hours after Day 28 AM dose (ie, approximately 12 hours after the previous PM dose).

연구 유형

중재적

등록 (실제)

275

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 미국
    • Alabama
      • Jasper, Alabama, 미국, 35501
        • Jasper Summit Research, LLC
    • Arizona
      • Phoenix, Arizona, 미국, 85006
        • Pulmonary Associates, PA
    • California
      • Fullerton, California, 미국, 92835
        • California Research Medical Group, Inc.
      • Los Angeles, California, 미국, 90095
        • UCLA David Geffen School of Medicine
      • Riverside, California, 미국, 92506
        • Integrated Research Group
      • Sacramento, California, 미국, 95819
        • Capital Allergy & Respiratory Disease Center
      • San Diego, California, 미국, 92120
        • Institute of HealthCare Assessment, Inc.
    • Florida
      • Clearwater, Florida, 미국, 33765
        • Clinical Research of West Florida
      • Tampa, Florida, 미국, 33603
        • Clinical Research of West Florida
    • Georgia
      • Austell, Georgia, 미국, 30106
        • Georgia Clinical Research
      • Lawrenceville, Georgia, 미국, 30046
        • Gwinnett Biomedical Research
    • Kansas
      • Topeka, Kansas, 미국, 66606
        • Veritas Clinical Specialities, LTD
    • Minnesota
      • Minneapolis, Minnesota, 미국, 55407
        • Minnesota Lung Center
    • North Carolina
      • Charlotte, North Carolina, 미국, 28207
        • American Health Research
      • Raleigh, North Carolina, 미국, 27607
        • North Carolina Clinical Research
    • Ohio
      • Cincinnati, Ohio, 미국, 45242
        • New Horizons Clinical Research
    • Oregon
      • Medford, Oregon, 미국, 97504
        • Clinical Research Institute of Southern Oregon, PC
      • Medford, Oregon, 미국, 97504
        • Sunstone Medical Research LLC
      • Portland, Oregon, 미국, 97202
        • Allergy Associates Research Center
    • South Carolina
      • Greenville, South Carolina, 미국, 29615
        • Upstate Pharmaceutical Research
      • Greenville, South Carolina, 미국, 29615
        • Greenville Pharmaceutical Research, Inc
      • Spartanburg, South Carolina, 미국, 29303
        • South Carolina Pharmaceutical Research
      • Union, South Carolina, 미국, 29379
        • CU Pharmacuetical Research
    • Texas
      • Houston, Texas, 미국, 77030
        • Baylor College of Medicine
      • New Braunfels, Texas, 미국, 78130
        • Central Texas Health Research
    • Virginia
      • Richmond, Virginia, 미국, 23225
        • Pulmonary Associates of Richmond, Inc.

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

35년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Male and female subjects age 35 through 75 years, inclusive.
  • A clinical diagnosis of moderate to severe COPD according to GOLD guidelines (2011).
  • Current smokers or ex-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, or equivalent).
  • Post-bronchodilator (following inhalation of ipratropium bromide MDI) FEV1 ≥ 30% and ≤ 70% of predicted normal value during the Screening Period.
  • Post-bronchodilator (following inhalation of ipratropium bromide MDI) FEV1/FVC ratio < 0.70 during the Screening Period.
  • Post-bronchodilator (following inhalation of ipratropium bromide MDI) improvement in FEV1 ≥ 12% and ≥ 100 mL during the Screening Period.
  • Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005).

  • Subject, if female ≤ 65 years of age and of child bearing potential, must have a negative serum pregnancy test at screening. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control:

    • a. An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation.
    • b. Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
    • c. Abstinence.
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • Current evidence or recent history of any clinically significant and unstable disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infarction, cardiac failure, uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities.
  • Current evidence or history of clinically significant abnormal cardiac rhythm and/or conduction findings, including Holter monitoring results during the Screening Period.
  • Concomitant pulmonary disease or primary diagnosis of asthma.
  • History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma of the skin
  • Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to the Screening Period.
  • Use of daily oxygen therapy > 10 hours per day.
  • Use of systemic steroids within 3 months prior to the Screening Period.
  • Respiratory tract infection within 6 weeks prior to or during the Screening Period.
  • History of tuberculosis, bronchiectasis or other non-specific pulmonary disease.
  • History of urinary retention or bladder neck obstruction type symptoms.
  • History of narrow-angle glaucoma.
  • Prolonged QTc interval (> 450msec for males and > 470msec for females) during the Screening Period, or history of long QT syndrome.
  • Recent history (previous 12 months) of excessive use or abuse of narcotic/illegal drugs.
  • History of hypersensitivity or intolerance to β2-agonists or anticholinergics.
  • Participation in another investigational drug study where drug was received within 30 days prior to the Screening Period.
  • Female subject who is pregnant or lactating

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: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: EP-101 Placebo
EP-101 Placebo AM + EP-101 Placebo PM
의약품: Placebo
EP-101 Placebo AM + EP-101 Placebo PM
다른 이름들:
  • SUN101
실험적: EP 101 12.5 mcg
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
의약품: EP-101 12.5 mcg
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
다른 이름들:
  • SUN101
실험적: EP-101 25 mcg
EP-101 25 mcg AM + EP-101 25 mcg PM
의약품: EP-101 25 mcg
EP-101 25 mcg AM + EP-101 25 mcg PM
다른 이름들:
  • SUN101
실험적: EP-101 50 mcg
EP-101 50 mcg AM + EP-101 50 mcg PM
의약품: EP-101 50 mcg
EP-101 50 mcg AM + EP-101 50 mcg PM
다른 이름들:
  • SUN101
실험적: EP-101 100 mcg
EP-101 100 mcg AM + EP-101 100 mcg PM
의약품: EP-101 100 mcg
EP-101 100 mcg AM + EP-101 100 mcg PM
다른 이름들:
  • SUN101

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)
기간: Baseline and Day 29
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the mean of the spirometry values collected at 23 hours 30 minutes and 24 hours after the in-clinic morning dose (i.e. approximately 12 hrs after the previous evening dose).
Baseline and Day 29

2차 결과 측정

결과 측정
측정값 설명
기간
The Standardized Change From Baseline FEV1 AUC(0-12)
기간: Day 28
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Day 28
The Standardized Change From Baseline FEV1 AUC(12-24)
기간: Day 28
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Day 28
The Peak FEV1 Change From Baseline
기간: Day 28
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Peak FEV1 is defined as the highest postdose FEV1 value within 4 hrs after the morning dose.
Day 28
The Number of Subjects With Treatment-emergent Adverse Events
기간: Baseline up to Day 28
Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Baseline up to Day 28
The Number of Subjects With Treatment-emergent Serious Adverse Events
기간: Baseline up to Day 28
Treatment-emergent serious adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Baseline up to Day 28
The Number of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation
기간: Baseline up to Day 28
Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Baseline up to Day 28
The Percentage of Subjects With Treatment-emergent Adverse Events
기간: Baseline up to Day 28
Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Baseline up to Day 28
The Percentage of Subjects With Treatment-emergent Serious Adverse Events
기간: Baseline up to Day 28
Treatment-emergent serious adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Baseline up to Day 28
The Percentage of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation
기간: Baseline up to Day 28
Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Baseline up to Day 28

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Sunovion Respiratory Development Inc.

수사관

  • 연구 책임자: Respiratory Medical Director, MD, Sunovion Respiratory Development

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

2012년 10월 1일

기본 완료 (실제)

2013년 4월 1일

연구 완료 (실제)

2013년 4월 1일

연구 등록 날짜

최초 제출

2012년 10월 10일

QC 기준을 충족하는 최초 제출

2012년 10월 10일

처음 게시됨 (추정)

2012년 10월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 3월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 2월 6일

마지막으로 확인됨

2018년 2월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • EP-101-04 (SUN101)

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. .

COPD에 대한 임상 시험

Placebo에 대한 임상 시험

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