이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

To Evaluate the Long-term Safety of (R,R)-Formoterol in Subjects With COPD

2012년 2월 21일 업데이트: Sunovion

A Multicenter, Open-Label, Randomized, Active-Controlled, Parallel Group Chronic Safety Study of (R,R)-Formoterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease

The purpose of this study is to determine the long-term safety of arformoterol over a period of 12 months in subjects with COPD

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

This was a multicenter, open-label, randomized, active controlled, parallel group chronic safety study of arformoterol 50 mcg once daily over a period of 12 months in subjects with COPD. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

연구 유형

중재적

등록 (실제)

799

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 미국
    • Alabama
      • Anniston, Alabama, 미국, 36207
        • Pinnacle Research Group
      • Birmingham, Alabama, 미국, 35211
        • Princeton Pulmonary Group, PC
      • Jasper, Alabama, 미국, 35501
        • Pulmonary & Sleep Associates of Jasper, PC
      • Mobile, Alabama, 미국, 36608
        • Pulmonary Associates of Mobile, P.C.
    • Arizona
      • Tucson, Arizona, 미국, 85712
        • Arizona Clinical Research Center, Inc.
    • California
      • Fair Oaks, California, 미국, 95628
        • Northern California Research Corp.
      • Fresno, California, 미국, 93720
        • SARC Research Center
      • Irvine, California, 미국, 92618
        • Irvine Center for Clinical Research
      • LaJolla, California, 미국, 92037
        • Scripps Clinic - Chest and Critical Care
      • Los Angeles, California, 미국, 90505
        • Torrance Clinical Research
      • Mission Hills, California, 미국, 91345
        • Facey Medical Center - Radiant Research
      • Murrieta, California, 미국, 92562
        • Office of Delmer Henninger, MD
      • Orange, California, 미국
        • Advanced Clinical Research Institute
      • Paramount, California, 미국, 90723
        • Center for Clinical Trials, LLC
      • Rancho Mirage, California, 미국, 92270
        • Advances in Medicine
      • Riverside, California, 미국, 92501
        • Inland Clinical Research, Inc.
      • San Diego, California, 미국, 92120
        • Institute of HealthCare Assessment, Inc.
      • San Diego, California, 미국, 92120
        • Wetlin Research Associates, Inc.
      • San Jose, California, 미국, 95128
        • San Jose Clinical Research, Inc.
      • Signal Hill, California, 미국, 90755
        • West Coast Clinical Trials
      • Walnut Creek, California, 미국, 94598
        • Allergy & Asthma Medical Group of Diablo Valley, Inc.
    • Colorado
      • Ft. Collins, Colorado, 미국, 80528
        • Northern Colorado Pulmonary Consultants, PC
    • Florida
      • Clearwater, Florida, 미국, 33765
        • Clinical Research of West Florida, Inc.
      • DeLand, Florida, 미국, 32720
        • University Clinical Research, DeLand
      • Melbourne, Florida, 미국, 32901
        • nTouch Research
      • St. Petersburg, Florida, 미국, 33710
        • nTouch Research
      • Tampa, Florida, 미국, 33613
        • USF Asthma, Allergy and Immunology
      • Tampa, Florida, 미국, 33615
        • AHS Medical Research, Inc.
    • Georgia
      • Atlanta, Georgia, 미국
        • New Horizon Health Research
      • Austell, Georgia, 미국, 30106
        • Protocare Trial, Inc.
      • Decatur, Georgia, 미국, 30033
        • nTouch Research
      • Marietta, Georgia, 미국, 30060
        • Marietta Pulmonary Medicine
      • Roswell, Georgia, 미국, 30076
        • North Point Pulmonary Associates
    • Idaho
      • Coeur d'Alene, Idaho, 미국, 83814
        • Pulmonary Consultants
    • Illinois
      • Chicago, Illinois, 미국, 60637
        • University of Chicago - Department of Medicine
      • Normal, Illinois, 미국, 61761
        • Sneeze, Wheeze and Itch, LLC
    • Indiana
      • Evansville, Indiana, 미국, 47714
        • Medisphere Medical Research Center, Llc
      • South Bend, Indiana, 미국, 46617
        • South Bend Clinic
    • Kansas
      • Shawnee Mission, Kansas, 미국, 66216
        • Heart of America Research Institute
    • Louisiana
      • Lafayette, Louisiana, 미국, 70503
        • Bendel Medical Associates
      • New Orleans, Louisiana, 미국, 70119
        • New Orleans Center for Clinical Research
      • Slidell, Louisiana, 미국, 70461
        • North Shore Research Associates
    • Maine
      • Bangor, Maine, 미국, 04401
        • Office of Paul A. Shapero, MD, PA
    • Massachusetts
      • Ayer, Massachusetts, 미국, 01432
        • Primary Care Cardiology Research, Inc.
      • Taunton, Massachusetts, 미국, 02780
        • Center for Clinical Research
    • Michigan
      • Ann Arbor, Michigan, 미국, 48106
        • ClinSite, Inc.
    • Minnesota
      • Minneapolis, Minnesota, 미국, 55407
        • Minnesota Lung Center
    • Missouri
      • Saint Louis, Missouri, 미국, 63108
        • Medex Healthcare Research, Inc.
      • St. Charles, Missouri, 미국, 63301-2847
        • Midwest Chest Consultants, PC
      • St. Louis,, Missouri, 미국, 63122
        • C.A.R.E Clinical Research
    • Montana
      • Butte, Montana, 미국, 59701
        • Office of Keith Popovich, MD
      • Missoula, Montana, 미국, 59804
        • Montana Medical Research, LLC
    • Nevada
      • Las Vegas, Nevada, 미국, 89104
        • Clinical Research Center Of Nevada
      • Las Vegas, Nevada, 미국, 89119
        • Advanced Biomedical Research of America
    • New Jersey
      • Margate City, New Jersey, 미국, 08402
        • Atlantic Research Associates, Inc.
      • South Bound Brook, New Jersey, 미국, 08880
        • UrgentMed Family Practice Medical
    • New Mexico
      • Albuquerque, New Mexico, 미국, 87108
        • Lovelace Scientific Resources - NM
    • New York
      • Endwell, New York, 미국, 13760
        • Endwell Family Physicians
      • Ithaca, New York, 미국, 14850
        • Asthma & Allergy Associates, PC
      • New York City, New York, 미국, 10016
        • N.Y. Pulmonary Associates
      • Rochester, New York, 미국, 14626
        • Ridgewood Medical Group
    • North Carolina
      • Charlotte, North Carolina, 미국, 28207
        • Charlotte Lung and Health Center
      • Raleigh, North Carolina, 미국
        • North Carolina Clinical Research
      • Wilmington, North Carolina, 미국, 28412
        • New Hanover Medical Research
    • North Dakota
      • Fargo, North Dakota, 미국, 58104
        • Odyssey Research Services
    • Ohio
      • Cincinnati, Ohio, 미국, 45241
        • New Horizons Clinical Research, Inc.
      • Cincinnati, Ohio, 미국, 45219
        • Community Research Management Associates, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, 미국, 73103
        • COR Clinical Research LLC
      • Tulsa, Oklahoma, 미국, 74135
        • Healthcare Research Consultants
    • Oregon
      • Medford, Oregon, 미국, 97504
        • Clinical Research Institute of Southern Oregon, PC
      • Medford, Oregon, 미국, 97504
        • Medford Medical Clinic, LLP
      • Portland, Oregon, 미국, 97213
        • Allergy Associates Research Center
    • Pennsylvania
      • Allentown, Pennsylvania, 미국, 18104
        • Northeast Clinical Research Center, Inc.
      • Pittsburgh, Pennsylvania, 미국, 15213
        • University of Pittsburgh
      • Ridley Park, Pennsylvania, 미국, 19078
        • Consortium Clinical Research, Ltd.
    • Rhode Island
      • East Providence, Rhode Island, 미국, 02914
        • Safe Harbor Clinical Research
    • South Carolina
      • Spartanburg, South Carolina, 미국, 29307
        • Spartanburg Pharmaceutical Research
    • Tennessee
      • Knoxville, Tennessee, 미국, 37920
        • Volunteer Research Group
    • Texas
      • Houston, Texas, 미국, 77030
        • Ben Taub General Hospital
      • Houston, Texas, 미국, 77084
        • Breath of Life Research Institute
      • Houston, Texas, 미국, 77074
        • S.W. Asthma Institute
      • San Antonio, Texas, 미국, 78217
        • Wellmed at Northern Hills
    • Virginia
      • Chesapeake, Virginia, 미국, 23321
        • Medsource, Inc.
      • Fredericksburg, Virginia, 미국, 22401
        • Pulmonary Associates of Fredericksburg, Inc.
      • Richmond, Virginia, 미국, 23225
        • Pulmonary Associates of Richmond, Inc.
      • Richmond, Virginia, 미국, 23226
        • Commonwealth Clinical Research
      • Richmond, Virginia, 미국, 23229
        • Virginia Adult & Pediatric Allergy & Asthma, PC Research Office
      • South Boston, Virginia, 미국, 24592
        • Pulmonary Research Partners, Inc.
    • Washington
      • Tacoma, Washington, 미국, 98405
        • Pulmonary Consultants, PLLC
    • West Virginia
      • Morgantown, West Virginia, 미국, 26505
        • Morgantown Pulmonary Associates

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 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

INCLUSION CRITERIA: In order to qualify for participation, subjects must meet the following criteria:

  • Must give written informed consent prior to participation. Women of childbearing potential must also sign the Women of Childbearing Potential Addendum.
  • Must be willing to comply with study procedures and visit schedule
  • Male or female >35 years of age
  • Female subjects <65 years of age must have a serum pregnancy test conducted at Visit 1 and confirmed negative prior to randomization. Subjects of childbearing potential must be using an acceptable method of birth control.
  • Female subjects who are considered not of childbearing potential must be: (1) documented surgically sterile, OR (2) postmenopausal
  • Have a primary diagnosis of COPD, which may include components of chronic bronchitis and/or emphysema. Diagnosis can be made during the screening process.
  • Have a minimum smoking history of 15 pack-years (pack-years = the number of cigarette packs per day times the number of years)
  • Medical Research Council (MRC) Dyspnea Scale Score >2
  • Have a baseline FEV1 <65% of predicted normal value and >0.70 L documented prior to randomization
  • Have an FEV1/FVC ratio <70% documented prior to randomization.
  • Have a chest x-ray that is consistent with the diagnosis of COPD and taken <3 months prior to Visit 1. If there is no chest x-ray taken 3 months prior to Visit 1, a chest x-ray will be performed prior to Visit 2.
  • Be able to complete all study questionnaires and logs reliably

EXCLUSION CRITERIA: In order to qualify for participation, subjects must not meet any of the following criteria:

  • Currently using disallowed medications or will be unable to complete the medication washout periods
  • Female subject who is pregnant or lactating
  • Have participated in an investigational drug study within 30 days prior to Visit 1 or who is currently participating in another investigational drug study
  • Subject whose schedule or travel prevents the completion of all required visits
  • Subject who is scheduled for in-patient hospitalization, including elective surgery (in-patient or out-patient) during the trial.
  • Subject with life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days prior to Visit 1
  • Known history of asthma or any chronic respiratory disease (including a current history of sleep apnea) other than COPD (chronic bronchitis and/or emphysema).
  • Subject with a blood eosinophil count >5%
  • Subject with clinically significant cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol
  • History of cancer except non-melanomatous skin cancer
  • History of lung resection of more than one full lobe
  • Subject who requires continuous supplemental oxygen therapy. The use of supplemental oxygen, not to exceed 2 L/minute, at nighttime only and/or only during exercise is allowed.
  • Have had a change in dose or type of any medications for COPD within 14 days prior to the screening visit
  • Have a known sensitivity to (R,R)-formoterol, ipratropium, salmeterol or albuterol or any of the excipients contained in any of these formulations
  • Have clinically significant abnormalities that may interfere with the metabolism or excretion of the study drug
  • Have a history of substance abuse or drug abuse within 12 months of Visit 1 or with a positive urine drug screen at the screening visit
  • Subject with clinically significant abnormal laboratory values
  • Subject with clinically significant abnormal 12-lead ECG that may jeopardize the subject's ability to complete the study
  • Subject using any prescription drug for which concomitant beta-agonist administration is contraindicated

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: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 1
Arformoterol tartrate 50 mcg QD
의약품: arformoterol
Arformoterol inhalation solution, 50 mcg QD
다른 이름들:
  • Brovana Inhalation Solution
  • (R,R)-Formoterol
활성 비교기: 2
Salmeterol 42 mcg BID
의약품: Salmeterol
Salmeterol MDI, 42 mcg BID
다른 이름들:
  • Serevent MDI
  • racemic formoterol

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Overall occurrence of adverse events
기간: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52

2차 결과 측정

결과 측정
기간
Laboratory parameters
기간: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
ECG parameters
기간: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
24-hour holter monitoring parameters
기간: Weeks -1, 0, 13, 26, 39, 52
Weeks -1, 0, 13, 26, 39, 52
Vital signs
기간: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Plasma arformoterol concentrations
기간: Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Weeks -1, 0, 3, 6, 9, 13, 26, 39, 52
Physical examination findings
기간: Weeks -1, 53
Weeks -1, 53

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Sunovion

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

2002년 6월 1일

기본 완료 (실제)

2004년 12월 1일

연구 완료 (실제)

2004년 12월 1일

연구 등록 날짜

최초 제출

2003년 7월 8일

QC 기준을 충족하는 최초 제출

2003년 7월 8일

처음 게시됨 (추정)

2003년 7월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2012년 2월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2012년 2월 21일

마지막으로 확인됨

2012년 2월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 091-060

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. .

arformoterol에 대한 임상 시험

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정황

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약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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