- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01307189
Effects of Tiotropium on Walking Capacity in Patients With COPD
This study was designed to test the following hypothesis:
A) The acute and long-term (3 weeks) bronchodilator-induced changes in exercise tolerance and in the physiological response during the endurance shuttle walk will be greater with tiotropium compared to placebo in COPD patients.
B) Three weeks of bronchodilation will be associated with increase activity of daily living as evaluated using the London Chest Activity Daily Living scale.
연구 개요
상세 설명
Objectives:
The purpose of this study is to compare the acute bronchodilator-induced changes in exercise tolerance during the endurance shuttle walk between tiotropium and placebo in COPD patients. Also, it will evaluate the physiological response (VE, VO2, VCO2, and heart rate) during the endurance shuttle walk in patients with COPD patients. Finally, it will compare the long-term (3 weeks) bronchodilator-induced changes in exercise tolerance during the endurance shuttle walk between tiotropium and placebo in COPD patients and evaluate the impact of long-term (3 weeks) bronchodilation on activity of daily living evaluated using the London Chest Activity Daily Living scale.
Methods:
This will be a double-blind, randomized and parallel-group study. Due to the long action duration of tiotropium (up to 4 weeks), a cross-over design, as we used in our ipratropium versus placebo study, is not appropriate in the present study. The study will require five visits at the Centre de recherche de l'Hopital Laval. The first visit will include review of the consent form, pulmonary function testing, and a maximal incremental shuttle walk. The following two visits (Visit 2 and 3) will be used to familiarize the participants to the shuttle endurance walking test. Salbutamol and ipratropium bromide will be stopped 6 hours prior to these visits while the remaining medication allowed during the study period (see below) will be continued as prescribed. The goal of the familiarization will be to reduce the learning effect that typically occurs when an individual completes the same endurance test several times 3. On visit 4, patients will be randomized to receive one of the two treatments: placebo or tiotropium 18 ug (Spiriva) using the handihaler device. Pulmonary function testing will then be performed and the London Chest Activity Daily Living scale will be administered. Two hours following the inhalation of the first study dose, pulmonary function testing will be repeated and the patients will perform an endurance shuttle walk. They will be provided enough medication for the study duration and discharged. The same procedure as Visit 4 will be completed three weeks later, on visit 5.
Data analysis:
The main outcome will be endurance time at day 21. This variable will be compared between the two treatment arms using an unpaired t-test. The endurance time at day 0 will also be compared between the two treatment arms using the same procedure. The time course of the cardiorespiratory parameters and dyspnea over time will be compared between the two exercise modalities. Comparisons will be done using a repeated measure design (ANOVA). Significance level will be set at a p value of 0.05. The two familiarization endurance shuttle walk tests performed at day -10 and day -5 will be used to evaluate the test-retest variability of this procedure.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Quebec, 캐나다, G1V 4G5
- Centre de recherche de l'IUCPQ
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- age > 50 years, smoking history > 10 packs/year, FEV1 < 70% of predicted and FEV1/FVC < 70%.
Exclusion Criteria:
- respiratory exacerbation within the 2 months preceding the study, history of asthma, significant O2 desaturation (SaO2 < 85%) at rest or during exercise, presence of another pathology that could influence exercise tolerance.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 위약
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Placebo diskus inhalation powder, once daily
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활성 비교기: 티오트로피움
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Tiotropium diskus inhalation powder, 18ug, once daily
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Endurance time during an endurance shuttle walk
기간: acute response (2.5 hours) following the administration of the active and comparison drug
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acute response (2.5 hours) following the administration of the active and comparison drug
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Compare the long-term bronchodilator-induced changes in exercise tolerance during the endurance shuttle walk
기간: three weeks
|
three weeks
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Evaluate the impact of long-term bronchodilation on activity of daily living evaluated using the London Chest Activity Daily Living scale
기간: three weeks
|
three weeks
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Cardio-respiratory responses during an endurance shutlle walk
기간: acute response following the administration of the study medication
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acute response following the administration of the study medication
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료 (실제)
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
- CER1199
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Tiotropium에 대한 임상 시험
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Orion Corporation, Orion Pharma완전한
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Guangzhou Institute of Respiratory DiseaseBoehringer Ingelheim모병
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Xiromed LLCLaboratorios Liconsa; Exeltis완전한
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Neutec Ar-Ge San ve Tic A.Ş완전한
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Boehringer Ingelheim종료됨