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Study to Investigate the Dose Response, Safety and Efficacy of Nebulized EP-101(SUN101) in Patients With Chronic Obstructive Pulmonary Disease (COPD): GOLDEN-1 Study

2018년 5월 8일 업데이트: Sunovion Respiratory Development Inc.

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Seven Arm, Four-Period Cross-over, Incomplete Block Design, 7-Day Dosing Study to Assess the Dose-Response, Safety, and Efficacy of EP-101 (SUN101) in Subjects With Moderate to Severe COPD

The purpose of this study is to determine steady-state efficacy and dose response profile and to assess safety and pharmacokinetic profile of nebulized EP-101(SUN101) after 7-day dosing using an investigational high efficiency nebulizer (eFlow®) compared with placebo and two active comparators in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, four-period, incomplete block design cross-over study using EP-101(SUN101) and open-label active controls (tiotropium bromide and ipratropium bromide). The study population will consist of subjects of 40-75 years of age with moderate to severe COPD. Approximately 133 subjects diagnosed with moderate to severe COPD will be enrolled in order to achieve minimum 105 subjects completing the study.

Following a run-in phase, each subject will be randomly assigned to one of 7 treatment sequences,(96 sequences when order of administration is considered), with each sequence comprised of four 7-day Treatment Periods. There will be a washout period of 7 days between each Treatment Period. Study visits will be conducted on Days 1 and 7 of each Treatment Period, with an overnight stay required in the clinic during these visits. A Final Study Visit will be conducted 7 days following the last study treatment.

During each Treatment Period, study treatments will be administered once daily (QD), except for ipratropium inhalation solution, which will be administered three times daily (TID). EP-101 (SUN101)active and placebo treatments will be administered using an investigational high-efficiency eFlow® nebulizer. Tiotropium bromide (Spiriva®) will be administered in an open-label manner via Handihaler® dry-powder inhaler (DPI). Ipratropium bromide inhalation solution will be administered in an open-label manner via general purpose nebulizer.

This study was previously posted by Elevation Pharmaceuticals, Inc. On September 5, 2012, Elevation was acquired by merger with Sunovion Pharmaceuticals Inc. ("Sunovion"), which resulted in Elevation becoming a direct wholly-owned subsidiary of Sunovion. In conjunction with this acquisition, the name of Elevation has been changed to Sunovion Respiratory Development Inc.

연구 유형

중재적

등록 (실제)

140

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 미국
    • Arizona
      • Phoenix, Arizona, 미국, 85006
        • Elevation Investigational Site
    • California
      • Los Angeles, California, 미국, 90048
        • Elevation Investigational Site
    • Florida
      • DeLand, Florida, 미국, 32720
        • Elevation Investigational Site
    • Kentucky
      • Madisonville, Kentucky, 미국, 42431
        • Elevation Investigational Site
    • Massachusetts
      • North Dartmouth, Massachusetts, 미국, 02747
        • Elevation Investigational Site
    • North Carolina
      • Charlotte, North Carolina, 미국, 28207
        • Elevation Investigational Site
      • Raleigh, North Carolina, 미국, 27607
        • Elevation Investigational Site
    • Oregon
      • Medford, Oregon, 미국, 97504
        • Elevation Investigational Site
    • South Carolina
      • Spartanburg, South Carolina, 미국, 29303
        • Elevation Investigational Site
    • Washington
      • Tacoma, Washington, 미국, 98418
        • Elevation Investigational Site
  • 영국
      • Manchester, 영국, M21 8AD
        • Elevation Investigational 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

40년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • 40-75 years of age
  • Clinical diagnosis of moderate to severe COPD
  • Current/ex-smokers with at least 10 pack-year smoking history
  • Post-bronchodilator FEV1 ≥ 30% and ≤ 70% predicted normal values
  • Post-bronchodilator FEV1/FVC ratio of ≤ 0.70
  • Post-bronchodilator improvement in FEV1 ≥ 12% and ≤ 30%, and a minimum of 100 mL
  • Willing and able to remain at the study site for at least 24 hours at each study visit
  • Signed written informed consent

Exclusion Criteria:

  • Current evidence or recent history of any clinically significant and unstable disease or abnormality (e.g., myocardial infarction, cardiac failure, uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes)
  • Primary diagnosis of asthma
  • History of malignancy within the past 5 years
  • History of COPD exacerbation within 6 weeks of Screening
  • Daily oxygen therapy > 10 hours per day
  • Systemic steroids use within 6 weeks of Screening
  • Respiratory tract infection within 6 weeks of Screening
  • History of tuberculosis, bronchiectasis
  • History of urinary retention or bladder neck obstruction type symptoms
  • History of glaucoma
  • Prolonged QTc interval (>460msec) or history of long QT syndrome
  • Recent history of alcohol or drug abuse
  • Females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable birth control methods
  • History of hypersensitivity or intolerance to aerosol medications
  • Participation in another investigational drug study within 30 days of Screening

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: 크로스오버 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: EP-101 via nebulizer (eFlow®) 25 ug
EP-101 via nebulizer (eFlow®)
의약품: EP-101 via nebulizer (eFlow®) 25 ug
EP-101 (25 ug ) Dose 1 administered once daily for 7 days
다른 이름들:
  • SUN101
활성 비교기: Tiotropium bromide via (Spiriva® Handihaler®)
의약품: Tiotropium bromide via (Spiriva® Handihaler®)
Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI
다른 이름들:
  • 티오트로피움 브로마이드
활성 비교기: Ipratropium bromide Inhalation Solution
Ipratropium bromide Inhalation Solution via Handihaler® DPI
의약품: Ipratropium bromide Inhalation Solution via Handihaler® DPI
Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer
다른 이름들:
  • Ipratropium bromide
위약 비교기: Placebo EP-101
Placebo
의약품: Placebo EP-101
Placebo EP-101 administered once daily for 7 days
다른 이름들:
  • 위약
실험적: EP-101 via nebulizer (eFlow®) 50 ug
EP-101 via nebulizer (eFlow®)
의약품: EP-101 via nebulizer (eFlow®) 50 ug
EP-101 (50 ug ) administered once daily for 7 days
다른 이름들:
  • SUN101
실험적: EP-101 via nebulizer (eFlow®) 100 ug
EP-101 via nebulizer (eFlow®)
의약품: EP-101 via nebulizer (eFlow®) 100 ug
EP-101 (100ug) administered once daily for 7 days
다른 이름들:
  • SUN101
실험적: EP-101 via nebulizer (eFlow®) 200 ug
EP-101 via nebulizer (eFlow®)
의약품: EP-101 via nebulizer (eFlow®) 200 ug
EP-101 (200) ug administered once daily for 7 days
다른 이름들:
  • SUN101

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Mean Change in 24 Post Dose Trough Forced Expiratory Volume in 1 Second (FEV1)
기간: Day 1 and Day 7
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 post dose for Day 1 and Day 7 within each Treatment Period. Baseline was calculated as the mean of the FEV1 values at 45 minutes and 15 minutes prior to the morning dose at Day 1 of each Treatment Period. Change from baseline was calculated as the trough FEV1 value minus the baseline for Day 1 and Day 7.
Day 1 and Day 7
Standardized Change in FEV1 Area Under the Curve (AUC) (0-12hr , 12-24hr, 0-24hr) on Day 1 and Day 7
기간: Day 1 and Day 7
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. The standardized FEV1 AUC(0-12hr and 12-24hr) on Day 1 and Day 7 was calculated using the trapezoidal rule from the changes in FEV1 at Day 1 and Day 7, respectively, from the baseline value (the mean of the two FEV1 values at 45 minutes and 15 minutes prior to morning dose at Day 1 of the respective Treatment Periods) and dividing by the actual length of the time interval.
Day 1 and Day 7

2차 결과 측정

결과 측정
측정값 설명
기간
Peak FEV1 (Maximum FEV1 During the First 4 Hours Post-dose on Day 1 and Day 7)
기간: Day 1 and Day 7
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines
Day 1 and Day 7
Treatment Responders (Number of Subjects With Clinically Meaningful Change From Pre-dose in Trough FEV1 on Day 1 and Day 7)
기간: Day 1 and Day 7
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Clinically meaningful is defined as when the change from baseline (mean of the two pre-dose values at Day 1) in 24 hour trough FEV1 on a SUN-101 treatment is more than 100 mL compared to the mean change in trough FEV1 from all subjects on the placebo treatment.
Day 1 and Day 7
Number of Participants With Adverse Events, Vital Signs, and Clinically Significant Abnormal ECG Values and Laboratory Tests
기간: Day 1 through Day 7
AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. Vital signs were performed during the screening period to confirm study eligibility and at the final study visit. ECGs were performed during the screening period to confirm study eligibility. Vital signs and ECG were additionally collected within 30 minutes pre-dose; and 30 minutes, and 1, 2, 4, 6, 12 hours, and 23 hours 45 minutes post-dose within each treatment period. Clinical laboratory assessments were conducted during the screening period, at each study visit during each treatment period, and at the final study visit.
Day 1 through Day 7
Rescue Medication Use
기간: Day 1 through Day 7
Mean number of puffs of daily rescue medication
Day 1 through Day 7
Treatment Responders (Percentage of Subjects With Clinically Meaningful Change From Pre-dose in Trough FEV1 on Day 1 and Day 7)
기간: Day 1 and Day 7
percentage of subjects with clinically meaningful change from pre-dose in trough FEV1 on Day 1 and Day 7 Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Day 1 and Day 7

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Sunovion Respiratory Development Inc.

수사관

  • 연구 책임자: Ahmet Tutuncu, M.D., Ph.D., Chief Medical Officer / Elevation Pharmaceuticals, Inc.

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 8월 1일

기본 완료 (실제)

2011년 12월 1일

연구 완료 (실제)

2011년 12월 1일

연구 등록 날짜

최초 제출

2011년 8월 29일

QC 기준을 충족하는 최초 제출

2011년 8월 29일

처음 게시됨 (추정)

2011년 8월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 5월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 5월 8일

마지막으로 확인됨

2018년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • EP-101-03

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위치

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