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Tiotropium In Exercise

2013년 11월 27일 업데이트: Boehringer Ingelheim

A Randomized, Double-blind, Placebo-controlled Two-year Trial to Examine the Changes in Exercise Endurance and COPD Treated With Tiotropium Once Daily (EXACTT)

The objective of this study is to evaluate the effects on exercise duration of 96 weeks treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in patients with COPD.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

519

단계

  • 4단계

연락처 및 위치

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

연구 장소

  • 대만
      • Keelung, 대만
        • 205.368.88604 Boehringer Ingelheim Investigational Site
      • Taichung, 대만
        • 205.368.88602 Boehringer Ingelheim Investigational Site
      • Taipei City, 대만
        • 205.368.88603 Boehringer Ingelheim Investigational Site
      • Taoyuan, 대만
        • 205.368.88601 Chang Gung Memorial Hosp-Linkou
  • 독일
      • Berlin, 독일
        • 205.368.49005 Boehringer Ingelheim Investigational Site
      • Freiburg/Breisgau, 독일
        • 205.368.49004 Boehringer Ingelheim Investigational Site
      • Köln, 독일
        • 205.368.49003 Boehringer Ingelheim Investigational Site
      • Münster, 독일
        • 205.368.49006 Boehringer Ingelheim Investigational Site
      • Schmallenberg, 독일
        • 205.368.49002 Boehringer Ingelheim Investigational Site
      • Tübingen, 독일
        • 205.368.49001 Boehringer Ingelheim Investigational Site
  • 러시아 연방
      • Moscow, 러시아 연방
        • 205.368.70001 Boehringer Ingelheim Investigational Site
      • Moscow, 러시아 연방
        • 205.368.70004 Boehringer Ingelheim Investigational Site
      • Moscow, 러시아 연방
        • 205.368.70005 Boehringer Ingelheim Investigational Site
      • Moscow, 러시아 연방
        • 205.368.70006 Boehringer Ingelheim Investigational Site
      • St. Petersburg, 러시아 연방
        • 205.368.70007 Boehringer Ingelheim Investigational Site
  • 미국
    • Alabama
      • Jasper, Alabama, 미국
        • 205.368.01023 Boehringer Ingelheim Investigational Site
    • Arizona
      • Phoenix, Arizona, 미국
        • 205.368.01022 Boehringer Ingelheim Investigational Site
    • California
      • Los Angeles, California, 미국
        • 205.368.01003 Boehringer Ingelheim Investigational Site
    • Colorado
      • Fort Collins, Colorado, 미국
        • 205.368.01008 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Hartford, Connecticut, 미국
        • 205.368.01017 Boehringer Ingelheim Investigational Site
      • Waterbury, Connecticut, 미국
        • 205.368.01028 Boehringer Ingelheim Investigational Site
    • Florida
      • Bay Pines, Florida, 미국
        • 205.368.01004 Boehringer Ingelheim Investigational Site
      • North Miami Beach, Florida, 미국
        • 205.368.01013 Boehringer Ingelheim Investigational Site
    • Kentucky
      • Hazard, Kentucky, 미국
        • 205.368.01025 Boehringer Ingelheim Investigational Site
    • Maine
      • Biddeford, Maine, 미국
        • 205.368.01029 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore, Maryland, 미국
        • 205.368.01016 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Boston, Massachusetts, 미국
        • 205.368.01002 Boehringer Ingelheim Investigational Site
    • Missouri
      • Kansas City, Missouri, 미국
        • 205.368.01021 Boehringer Ingelheim Investigational Site
    • New York
      • Albany, New York, 미국
        • 205.368.01014 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, 미국
        • 205.368.01030 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Charleston, South Carolina, 미국
        • 205.368.01018 Boehringer Ingelheim Investigational Site
      • Gaffney, South Carolina, 미국
        • 205.368.01027 Boehringer Ingelheim Investigational Site
      • Greenville, South Carolina, 미국
        • 205.368.01019 Boehringer Ingelheim Investigational Site
      • Spartanburg, South Carolina, 미국
        • 205.368.01020 Boehringer Ingelheim Investigational Site
      • Union, South Carolina, 미국
        • 205.368.01024 Boehringer Ingelheim Investigational Site
    • Texas
      • Dallas, Texas, 미국
        • 205.368.01015 Boehringer Ingelheim Investigational Site
  • 브라질
      • Goiânia, 브라질
        • 205.368.55003 Boehringer Ingelheim Investigational Site
      • Porto Alegre - RS, 브라질
        • 205.368.55004 Boehringer Ingelheim Investigational Site
      • Sao Paulo, 브라질
        • 205.368.55002 Boehringer Ingelheim Investigational Site
  • 스페인
      • Badalona (Barcelona), 스페인
        • 205.368.34005 Hospital Germans Trias i Pujol
      • Barakaldo (Bilbao), 스페인
        • 205.368.34002 Hospital de Cruces
      • Barcelona, 스페인
        • 205.368.34001 Hospital Clinic i Provincial de Barcelona
      • Madrid, 스페인
        • 205.368.34003 Hospital Gregorio Maranon
      • Sevilla, 스페인
        • 205.368.34004 Hospital Universitario Vírgen del Rocío
      • Sevilla, 스페인
        • 205.368.34006 Boehringer Ingelheim Investigational Site
  • 아르헨티나
      • Rosario, 아르헨티나
        • 205.368.54001 Boehringer Ingelheim Investigational Site
      • Vicente López, 아르헨티나
        • 205.368.54002 Boehringer Ingelheim Investigational Site
  • 우크라이나
      • Dnyepropyetrovsk, 우크라이나
        • 205.368.38003 Boehringer Ingelheim Investigational Site
      • Kiev, 우크라이나
        • 205.368.38001 Boehringer Ingelheim Investigational Site
      • Kiev, 우크라이나
        • 205.368.38002 Boehringer Ingelheim Investigational Site
  • 이탈리아
      • Ferrara, 이탈리아
        • 205.368.39006 Boehringer Ingelheim Investigational Site
      • Milano, 이탈리아
        • 205.368.39004 Boehringer Ingelheim Investigational Site
      • Parma, 이탈리아
        • 205.368.39002 Boehringer Ingelheim Investigational Site
      • Pisa, 이탈리아
        • 205.368.39001 Boehringer Ingelheim Investigational Site
  • 캐나다
    • British Columbia
      • Vancouver, British Columbia, 캐나다
        • 205.368.07006 Boehringer Ingelheim Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, 캐나다
        • 205.368.07001 Boehringer Ingelheim Investigational Site
      • Winnipeg, Manitoba, 캐나다
        • 205.368.07003 Boehringer Ingelheim Investigational Site
    • Ontario
      • Hamilton, Ontario, 캐나다
        • 205.368.07004 Boehringer Ingelheim Investigational Site
      • Hamilton, Ontario, 캐나다
        • 205.368.07005 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, 캐나다
        • 205.368.07008 Boehringer Ingelheim Investigational Site
  • 포르투갈
      • Coimbra, 포르투갈
        • 205.368.35103 Boehringer Ingelheim Investigational Site
      • Matosinhos, 포르투갈
        • 205.368.35102 Boehringer Ingelheim 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 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion criteria

  1. All patients must sign an informed consent
  2. Diagnosis of COPD with specific spirometric criteria (determined at study visits)
  3. Age >= 40 years
  4. Medical Research Council Dyspnoea score >= 2
  5. Current or ex-smoker with a >= 10 pack-year smoking history
  6. Ability to exercise on treadmill

Exclusion criteria

  1. Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment
  2. Clinical history of asthma
  3. Use of supplemental oxygen therapy
  4. Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)
  5. Recent history (<= 12 months) of myocardial infarction
  6. Unstable or life-threatening cardiac arrhythmia
  7. Malignancy treated with radiation therapy or chemotherapy in the last 5 years
  8. Pregnant or nursing women
  9. Known hypersensitivity to anticholinergic drugs or any component of the study medications
  10. Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1
  11. Estimated life expectancy < 2 years
  12. Symptomatic prostatic hyperplasia or bladder neck obstruction
  13. Known narrow-angle glaucoma
  14. Any condition that is contraindicated for exercise
  15. Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing
  16. Body mass index < 18 kg/m2 or >35 kg/m2 list truncated for space

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: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: tiotropium 18mcg
Oral inhalation once daily of 18mcg tiotropium via handihaler
의약품: tiotropium 18 mcg
Oral inhalation once daily of 18mcg tiotropium via handihaler
위약 비교기: Placebo
Oral inhalation once daily of placebo matching tiotropium via handihaler
의약품: Placebo
Oral inhalation of once-daily placebo matching tiotropium via handihaler

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase
기간: baseline, 96 weeks
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
baseline, 96 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase
기간: baseline, 8 weeks
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
baseline, 8 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase
기간: baseline, 16 weeks
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
baseline, 16 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase
기간: baseline, 32 weeks
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
baseline, 32 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase
기간: baseline, 48 weeks
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
baseline, 48 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase
기간: baseline, 64 weeks
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
baseline, 64 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase
기간: baseline, 80 weeks
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
baseline, 80 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase
기간: baseline, 8 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 8 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase
기간: baseline, 16 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 16 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase
기간: baseline, 32 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 32 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase
기간: baseline, 48 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 48 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase
기간: baseline, 64 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 64 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase
기간: baseline, 80 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 80 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase
기간: baseline, 96 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 96 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase
기간: baseline, 8 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 8 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase
기간: baseline, 16 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 16 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase
기간: baseline, 32 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 32 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase
기간: baseline, 48 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 48 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase
기간: baseline, 64 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 64 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase
기간: baseline, 80 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 80 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase
기간: baseline, 96 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 96 weeks
Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase
기간: baseline, 8 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 8 weeks
Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase
기간: baseline, 16 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 16 weeks
Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase
기간: baseline, 32 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 32 weeks
Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase
기간: baseline, 48 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 48 weeks
Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase
기간: baseline, 64 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 64 weeks
Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase
기간: baseline, 80 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 80 weeks
Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase
기간: baseline, 96 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 96 weeks
Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase
기간: baseline, 8 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 8 weeks
Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase
기간: baseline, 16 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 16 weeks
Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase
기간: baseline, 32 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 32 weeks
Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase
기간: baseline, 48 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 48 weeks
Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase
기간: baseline, 64 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 64 weeks
Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase
기간: baseline, 80 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 80 weeks
Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase
기간: baseline, 96 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 96 weeks
Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase
기간: baseline, 96 weeks
Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)
baseline, 96 weeks
Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase
기간: baseline, 96 weeks
Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)
baseline, 96 weeks
Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase
기간: baseline, 96 weeks
Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)
baseline, 96 weeks
Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase
기간: baseline, 8 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 8 weeks
Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase
기간: baseline, 16 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 16 weeks
Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase
기간: baseline, 32 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 32 weeks
Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase
기간: baseline, 48 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 48 weeks
Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase
기간: baseline, 64 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 64 weeks
Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase
기간: baseline, 80 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 80 weeks
Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase
기간: baseline, 96 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 96 weeks
Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase
기간: baseline, 8 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 8 weeks
Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase
기간: baseline, 16 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 16 weeks
Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase
기간: baseline, 32 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 32 weeks
Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase
기간: baseline, 48 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 48 weeks
Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase
기간: baseline, 64 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 64 weeks
Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase
기간: baseline, 80 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 80 weeks
Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase
기간: baseline, 96 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 96 weeks
Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase
기간: baseline, 96 weeks
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
baseline, 96 weeks
Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase
기간: baseline, 96 weeks
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
baseline, 96 weeks
Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase
기간: baseline, 96 weeks
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
baseline, 96 weeks
Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase
기간: baseline, 96 weeks
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
baseline, 96 weeks
Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase
기간: baseline, 96 weeks
COPD exacerbation is a complex of symptoms related to COPD with a duration of three days or more requiring a change of treatment.
baseline, 96 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase
기간: baseline, 100 weeks
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
baseline, 100 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase
기간: baseline, 100 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 100 weeks
Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase
기간: baseline, 100 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 100 weeks
Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase
기간: baseline, 100 weeks
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
baseline, 100 weeks
Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase
기간: baseline, 100 weeks
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
baseline, 100 weeks
Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase
기간: baseline, 100 weeks
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
baseline, 100 weeks
Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase
기간: baseline, 100 weeks
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
baseline, 100 weeks
Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status
기간: From first drug administration until 30 days after last drug administration
Clinical Relevant Abnormalities for Vital Signs and Physical examination, including vital status. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.
From first drug administration until 30 days after last drug administration

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Boehringer Ingelheim

협력자

Pfizer

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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

2007년 8월 1일

기본 완료 (실제)

2010년 6월 1일

연구 등록 날짜

최초 제출

2007년 9월 3일

QC 기준을 충족하는 최초 제출

2007년 9월 3일

처음 게시됨 (추정)

2007년 9월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 12월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 11월 27일

마지막으로 확인됨

2013년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 205.368
  • 2006-004610-41 (EudraCT 번호: EudraCT)

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. .

tiotropium 18 mcg에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Gabon

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다