- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01131806
Comparing Treatment Efficacy With HD/MD Flu Plus Sal in Chronic Obstructive Pulmonary Disease (COPD) Patients
Comparing Treatment Efficacy With High and Medium Dose of Fluticasone in Combination With Salmeterol in COPD Patients
연구 개요
상태
정황
상세 설명
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and the use of health care resources worldwide. It is characterized by chronic progressive symptoms, airflow obstruction, and impaired health status, which is worse in those who have frequent, acute episodes of symptom exacerbation. Treatment for COPD is focused on minimizing risk factors, improving symptoms, and preventing exacerbations.
Pulmonary inflammation is the key factor in COPD. Inhaled long-acting β2 agonists (LABA) improve airflow obstruction, control of symptoms, and health status in patients with COPD over 3 to 4 months. Inhaled corticosteroids (ICS) are currently the most popular anti-inflammatory medications for use in symptomatic patients with COPD. Previous large scaled randomized control study discovered long-term use of ICS didn't modified annual decline of lung function in COPD patients, but may reduce the frequency of exacerbations, especially when combined with an LABA.
Combination treatment with ICS and LABA has been widely used for patients with COPD and attains an improved control of symptoms and lung function, with no greater risk of side-effects than that of treatment with either component alone. Combined ICS/LABA will result in better treatment effects that are superior to those associated with either drug alone. However, the treatment efficacy between high and medium dose of inhaled corticosteroid in combination of LABA is still unknown. The aim of the current study is to investigate the treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in COPD patients.
연구 유형
등록 (예상)
단계
- 4단계
연락처 및 위치
연구 장소
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Taipei City, 대만, 112
- 모병
- Chest department, Veteran General Hospital-TAIPEI
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연락하다:
- Diahn-Warng Perng, PhD
- 전화번호: 3194 +886-2-28712121
- 이메일: dwperng@vghtpe.gov.tw
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연락하다:
- Kang-Cheng Su, MD
- 전화번호: 8928 +886-2-28712121
- 이메일: kcsu@vghtpe.gov.tw
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부수사관:
- Kang-Cheng Su, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or female outpatients aged ≧ 40 years.
- Current or ex-smoker, with smoking history ≧ 10 pack- years
- COPD (FEV1/FVC < 70%) patients with post-bronchodilator FEV1 ≦ 70% predicted value, without bronchial reversibility (≦10% increase post bronchodilator).
Exclusion Criteria:
- Diagnosis or suspicion of sleep apnea
- Concurrent rhinitis, eczema, and asthma
- Clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease
- A chest X-ray indicating diagnosis other than COPD that might interfere with the study.
- Major disease abnormalities are uncontrolled on therapy.
- Alcohol or medication abuse.
- Patients had lower respiratory tract infections or received systemic steroid in the 4 weeks prior to the commencement of study.
- Unable or unwilling to comply with all protocol specified procedures.
공부 계획
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 |
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활성 비교기: MD Flu/Sal
fluticasone125 mcg/ salmeterol 25 mcg 2puffs (medium dose group) inhaled twice daily; salbutamol evohaler allowed from 100 to 400 mcg for inhalation as needed basis.
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fluticasone 125mcg/salmeterol 25mcg 2puffs/day x 52 weeks
다른 이름들:
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실험적: HD Flu/Sal
fluticasone 250 mcg/salmeterol 25 mcg 2puffs (high dose group) inhaled twice daily; salbutamol evohaler allowed from 100 to 400 mcg for inhalation as needed basis.
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fluticasone 250mcg/salmeterol 25mcg 2puffs/day x 52 weeks
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The change of lung function parameters(FEV1&FVC) at different time points
기간: baseline, week 12, 28 and 52
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The changes of lung function parameters, including post bronchodilation forced expiratory volume in first second (FEV1) and forced vital capacity (FVC), at different time points, including baseline, 12th week, 28th week, and ending (52th week).
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baseline, week 12, 28 and 52
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Annual rate of acute exacerbations
기간: 1 year
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total numbers of acute exacerbation throughout the study year
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1 year
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Life quality evaluation
기간: baseline, week 12, 28, and 52
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The changes of Health-related quality of life assessed by CAT questionnaire before and after treatment.
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baseline, week 12, 28, and 52
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Annual incidence of community-acquired pneumonia
기간: 1 year
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Annual incidence of community-acquired pneumonia throughout the study year
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1 year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Diahn-Warng Perng, PhD, Taipei Veterans General Hospital, Taiwan
간행물 및 유용한 링크
일반 간행물
- Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Yates JC, Vestbo J; TORCH investigators. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. 2007 Feb 22;356(8):775-89. doi: 10.1056/NEJMoa063070.
- Keating GM, McCormack PL. Salmeterol/fluticasone propionate: a review of its use in the treatment of chronic obstructive pulmonary disease. Drugs. 2007;67(16):2383-405. doi: 10.2165/00003495-200767160-00006.
- Hanania NA, Darken P, Horstman D, Reisner C, Lee B, Davis S, Shah T. The efficacy and safety of fluticasone propionate (250 microg)/salmeterol (50 microg) combined in the Diskus inhaler for the treatment of COPD. Chest. 2003 Sep;124(3):834-43. doi: 10.1378/chest.124.3.834.
- Szafranski W, Cukier A, Ramirez A, Menga G, Sansores R, Nahabedian S, Peterson S, Olsson H. Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. Eur Respir J. 2003 Jan;21(1):74-81. doi: 10.1183/09031936.03.00031402. Erratum In: Eur Respir J. 2003 May;21(5):912.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- VGHIRB No. 98-10-16
- CM981016 (기타 식별자: Veterans General Hospital-TAIPEI)
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. .
fluticasone/ salmeterol 125/25 mcg/puff에 대한 임상 시험
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Neutec Ar-Ge San ve Tic A.Ş완전한
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Respirent Pharmaceuticals Co Ltd.Becro Ltd.모병
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Respirent Pharmaceuticals Co Ltd.완전한
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GlaxoSmithKline완전한천식미국, 아르헨티나, 독일, 대한민국, 루마니아, 러시아 연방, 스페인, 네덜란드, 멕시코, 브라질, 칠레, 체코