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Tiotropium In Exercise

27 ноября 2013 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

519

Фаза

  • Фаза 4

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

40 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: tiotropium 18mcg
Oral inhalation once daily of 18mcg tiotropium via handihaler
Лекарство: tiotropium 18 mcg
Oral inhalation once daily of 18mcg tiotropium via handihaler
Плацебо Компаратор: Placebo
Oral inhalation once daily of placebo matching tiotropium via handihaler
Лекарство: Placebo
Oral inhalation of once-daily placebo matching tiotropium via handihaler

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase
Временное ограничение: baseline, 96 weeks
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
baseline, 96 weeks

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

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Спонсор

Boehringer Ingelheim

Соавторы

Pfizer

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 августа 2007 г.

Первичное завершение (Действительный)

1 июня 2010 г.

Даты регистрации исследования

Первый отправленный

3 сентября 2007 г.

Впервые представлено, что соответствует критериям контроля качества

3 сентября 2007 г.

Первый опубликованный (Оценивать)

5 сентября 2007 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

24 декабря 2013 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

27 ноября 2013 г.

Последняя проверка

1 сентября 2013 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

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

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования tiotropium 18 mcg

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