- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02238119
Efficacy and Safety of Free Combination of Tiotropium + Formoterol Compared to Formoterol and Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)
2014년 9월 11일 업데이트: Boehringer Ingelheim
A Randomised, Double-blind, Double-dummy, Crossover Efficacy and Safety Comparison of 6-week Treatment Periods of the Free Combination of Tiotropium Inhalation Powder Capsule (18 μg) + Formoterol Inhalation Powder Capsule (12 μg) QD, Tiotropium Inhalation Powder Capsule (18 μg) QD and Formoterol Inhalation Powder Capsule (12 μg) BID in Patients With COPD
Study to evaluate the lung function response to the free once-daily combination of tiotropium + formoterol compared to formoterol BID and tiotropium QD
연구 개요
연구 유형
중재적
등록 (실제)
74
단계
- 2 단계
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 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- All patients had to sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which included medication washout and restrictions
All patients had to have a diagnosis of chronic obstructive pulmonary disease and had to meet the following spirometric criteria:
- Patients had to have relatively stable moderate to severe airway obstruction with an FEV1 ≤ 60% of predicted normal and FEV1 ≤ 70% of FVC (Visits 1 and 2)
- Male or female patients 40 years of age or older
- Patients had to be current or ex-smokers with a smoking history of more than 10 pack-years (Patients who had never smoked cigarettes had to be excluded)
- Patients had to be able to perform technically acceptable pulmonary function tests and had to be able to maintain records (Patient Daily Diary Record) during the study period as required in the protocol
- Patients had to be able to inhale medication in a competent manner from the HandiHaler® device, the Blue Inhaler device and from a metered dose inhaler (MDI)
Exclusion Criteria:
- Patients with significant diseases other than COPD had to be excluded. A significant disease was defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
- Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis if the abnormality defined a disease listed as an exclusion criterion
- All patients with an serum glutamate oxaloacetate transaminase (SGOT) > 80 IU/L, serum glutamate pyruvate transaminase (SGPT) > 80 IU/L, bilirubin > 17 μmol/L or creatinine > 110 μmol/L (males) / 95 μmol/L (females) had to be excluded regardless of clinical condition
- Patients with a recent history (i.e., six months or less) of myocardial infarction
- Patients with any cardiac arrhythmia requiring drug therapy or who had been hospitalised for heart failure within the past three years
- Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma were allowed
Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.
Patients with prostatic hypertrophy controlled by medication were allowed
- Patients with known narrow-angle glaucoma
- Patients with a history of asthma, allergic rhinitis or who had a total blood eosinophil count ≥600 mm3
- Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis
- Patients with known active tuberculosis
- Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion No. 1.
- Patients who had undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons had to be evaluated as per exclusion criterion No. 1
- Patients who completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1)
- Patients who regularly used daytime oxygen therapy
- Patients who had taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1)
- Patients who were treated with beta-blocker medications. Note: cardioselective beta blocker eye medications (e.g. Betoptic®) for treatment of non-narrow angle glaucoma were allowed
- Patients who were treated with oral beta-adrenergics
- Patients who were treated with cromolyn sodium or nedocromil sodium
- Patients who were treated with antihistamines (H1 receptor antagonists), antileukotrienes or leukotriene receptor antagonists for asthma or excluded allergic conditions. See exclusion criterion No. 9
- Patients using oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
- Patients with known hypersensitivity to anticholinergic drugs, beta-adrenergics, lactose or any other components of the inhalation capsule delivery systems
- Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception for the previous 3 months (i.e. oral contraceptives, intrauterine devices, diaphragm or subdermal implants e.g., Norplant®)
- Patients with previous participation (receipt of randomised treatment) in this study
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: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: tiotropium + formoterol
|
|
활성 비교기: tiotropium
|
|
활성 비교기: formoterol
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Change in area under the curve from pre-dose to 12 hours of the forced expiratory volume in one second (FEV1 AUC0-12h)
기간: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
Change in FEV1 AUC0-24h
기간: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in FEV1 AUC12-24h
기간: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Change in AUC of the forced vital capacity (FVC AUC0-12h)
기간: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Change in FVC AUC0-24h
기간: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Change in FVC AUC12-24h
기간: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Change in peak FEV1 response
기간: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Change in trough FEV1 response
기간: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Change in peak FVC response
기간: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Change in trough FVC response
기간: after 6 weeks of each treatment
|
after 6 weeks of each treatment
|
|
Individual FEV1measurements at each time point
기간: up to 6 weeks
|
up to 6 weeks
|
|
Individual FVCmeasurements at each time point
기간: up to 6 weeks
|
up to 6 weeks
|
|
Peak expiratory flow rate (PEFR)
기간: weeks 4 to 6 of each treatment period
|
measured twice daily
|
weeks 4 to 6 of each treatment period
|
Number of inhalations of rescue salbutamol therapy used per day
기간: weeks 4 to 6 of each treatment period
|
weeks 4 to 6 of each treatment period
|
|
Assessment of daytime COPD symptom score rated on a 6-point rating scale
기간: weeks 4 to 6 of each treatment period
|
weeks 4 to 6 of each treatment period
|
|
Assessment of nighttime COPD symptom score rated on a 5-point rating scale
기간: weeks 4 to 6 of each treatment period
|
weeks 4 to 6 of each treatment period
|
|
Number of patients with adverse events
기간: up to 23 weeks
|
up to 23 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
유용한 링크
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 2월 1일
기본 완료 (실제)
2002년 8월 1일
연구 등록 날짜
최초 제출
2014년 9월 11일
QC 기준을 충족하는 최초 제출
2014년 9월 11일
처음 게시됨 (추정)
2014년 9월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 9월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 9월 11일
마지막으로 확인됨
2014년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1184.3
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. .
티오트로피움에 대한 임상 시험
-
Orion Corporation, Orion Pharma완전한
-
Guangzhou Institute of Respiratory DiseaseBoehringer Ingelheim모병
-
Xiromed LLCLaboratorios Liconsa; Exeltis완전한
-
Neutec Ar-Ge San ve Tic A.Ş완전한
-
Boehringer Ingelheim종료됨