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Tiotropium In Exercise

2013年11月27日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

519

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Alabama
      • Jasper、Alabama、アメリカ
        • 205.368.01023 Boehringer Ingelheim Investigational Site
    • Arizona
      • Phoenix、Arizona、アメリカ
        • 205.368.01022 Boehringer Ingelheim Investigational Site
    • California
      • Los Angeles、California、アメリカ
        • 205.368.01003 Boehringer Ingelheim Investigational Site
    • Colorado
      • Fort Collins、Colorado、アメリカ
        • 205.368.01008 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Hartford、Connecticut、アメリカ
        • 205.368.01017 Boehringer Ingelheim Investigational Site
      • Waterbury、Connecticut、アメリカ
        • 205.368.01028 Boehringer Ingelheim Investigational Site
    • Florida
      • Bay Pines、Florida、アメリカ
        • 205.368.01004 Boehringer Ingelheim Investigational Site
      • North Miami Beach、Florida、アメリカ
        • 205.368.01013 Boehringer Ingelheim Investigational Site
    • Kentucky
      • Hazard、Kentucky、アメリカ
        • 205.368.01025 Boehringer Ingelheim Investigational Site
    • Maine
      • Biddeford、Maine、アメリカ
        • 205.368.01029 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore、Maryland、アメリカ
        • 205.368.01016 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Boston、Massachusetts、アメリカ
        • 205.368.01002 Boehringer Ingelheim Investigational Site
    • Missouri
      • Kansas City、Missouri、アメリカ
        • 205.368.01021 Boehringer Ingelheim Investigational Site
    • New York
      • Albany、New York、アメリカ
        • 205.368.01014 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Tulsa、Oklahoma、アメリカ
        • 205.368.01030 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Charleston、South Carolina、アメリカ
        • 205.368.01018 Boehringer Ingelheim Investigational Site
      • Gaffney、South Carolina、アメリカ
        • 205.368.01027 Boehringer Ingelheim Investigational Site
      • Greenville、South Carolina、アメリカ
        • 205.368.01019 Boehringer Ingelheim Investigational Site
      • Spartanburg、South Carolina、アメリカ
        • 205.368.01020 Boehringer Ingelheim Investigational Site
      • Union、South Carolina、アメリカ
        • 205.368.01024 Boehringer Ingelheim Investigational Site
    • Texas
      • Dallas、Texas、アメリカ
        • 205.368.01015 Boehringer Ingelheim Investigational Site
  • アルゼンチン
      • Rosario、アルゼンチン
        • 205.368.54001 Boehringer Ingelheim Investigational Site
      • Vicente López、アルゼンチン
        • 205.368.54002 Boehringer Ingelheim Investigational Site
  • イタリア
      • Ferrara、イタリア
        • 205.368.39006 Boehringer Ingelheim Investigational Site
      • Milano、イタリア
        • 205.368.39004 Boehringer Ingelheim Investigational Site
      • Parma、イタリア
        • 205.368.39002 Boehringer Ingelheim Investigational Site
      • Pisa、イタリア
        • 205.368.39001 Boehringer Ingelheim Investigational Site
  • ウクライナ
      • Dnyepropyetrovsk、ウクライナ
        • 205.368.38003 Boehringer Ingelheim Investigational Site
      • Kiev、ウクライナ
        • 205.368.38001 Boehringer Ingelheim Investigational Site
      • Kiev、ウクライナ
        • 205.368.38002 Boehringer Ingelheim Investigational Site
  • カナダ
    • British Columbia
      • Vancouver、British Columbia、カナダ
        • 205.368.07006 Boehringer Ingelheim Investigational Site
    • Manitoba
      • Winnipeg、Manitoba、カナダ
        • 205.368.07001 Boehringer Ingelheim Investigational Site
      • Winnipeg、Manitoba、カナダ
        • 205.368.07003 Boehringer Ingelheim Investigational Site
    • Ontario
      • Hamilton、Ontario、カナダ
        • 205.368.07004 Boehringer Ingelheim Investigational Site
      • Hamilton、Ontario、カナダ
        • 205.368.07005 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal、Quebec、カナダ
        • 205.368.07008 Boehringer Ingelheim Investigational Site
  • スペイン
      • Badalona (Barcelona)、スペイン
        • 205.368.34005 Hospital Germans Trias i Pujol
      • Barakaldo (Bilbao)、スペイン
        • 205.368.34002 Hospital de Cruces
      • Barcelona、スペイン
        • 205.368.34001 Hospital Clinic i Provincial de Barcelona
      • Madrid、スペイン
        • 205.368.34003 Hospital Gregorio Maranon
      • Sevilla、スペイン
        • 205.368.34004 Hospital Universitario Vírgen del Rocío
      • Sevilla、スペイン
        • 205.368.34006 Boehringer Ingelheim Investigational Site
  • ドイツ
      • Berlin、ドイツ
        • 205.368.49005 Boehringer Ingelheim Investigational Site
      • Freiburg/Breisgau、ドイツ
        • 205.368.49004 Boehringer Ingelheim Investigational Site
      • Köln、ドイツ
        • 205.368.49003 Boehringer Ingelheim Investigational Site
      • Münster、ドイツ
        • 205.368.49006 Boehringer Ingelheim Investigational Site
      • Schmallenberg、ドイツ
        • 205.368.49002 Boehringer Ingelheim Investigational Site
      • Tübingen、ドイツ
        • 205.368.49001 Boehringer Ingelheim Investigational Site
  • ブラジル
      • Goiânia、ブラジル
        • 205.368.55003 Boehringer Ingelheim Investigational Site
      • Porto Alegre - RS、ブラジル
        • 205.368.55004 Boehringer Ingelheim Investigational Site
      • Sao Paulo、ブラジル
        • 205.368.55002 Boehringer Ingelheim Investigational Site
  • ポルトガル
      • Coimbra、ポルトガル
        • 205.368.35103 Boehringer Ingelheim Investigational Site
      • Matosinhos、ポルトガル
        • 205.368.35102 Boehringer Ingelheim Investigational Site
  • ロシア連邦
      • Moscow、ロシア連邦
        • 205.368.70001 Boehringer Ingelheim Investigational Site
      • Moscow、ロシア連邦
        • 205.368.70004 Boehringer Ingelheim Investigational Site
      • Moscow、ロシア連邦
        • 205.368.70005 Boehringer Ingelheim Investigational Site
      • Moscow、ロシア連邦
        • 205.368.70006 Boehringer Ingelheim Investigational Site
      • St. Petersburg、ロシア連邦
        • 205.368.70007 Boehringer Ingelheim Investigational Site
  • 台湾
      • Keelung、台湾
        • 205.368.88604 Boehringer Ingelheim Investigational Site
      • Taichung、台湾
        • 205.368.88602 Boehringer Ingelheim Investigational Site
      • Taipei City、台湾
        • 205.368.88603 Boehringer Ingelheim Investigational Site
      • Taoyuan、台湾
        • 205.368.88601 Chang Gung Memorial Hosp-Linkou

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

40年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：tiotropium 18mcg
Oral inhalation once daily of 18mcg tiotropium via handihaler
薬：tiotropium 18 mcg
Oral inhalation once daily of 18mcg tiotropium via handihaler
プラセボコンパレーター：Placebo
Oral inhalation once daily of placebo matching tiotropium via handihaler
薬：Placebo
Oral inhalation of once-daily placebo matching tiotropium via handihaler

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase
時間枠：baseline, 96 weeks
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
baseline, 96 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Boehringer Ingelheim

協力者

Pfizer

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2007年8月1日

一次修了 (実際)

2010年6月1日

試験登録日

最初に提出

2007年9月3日

QC基準を満たした最初の提出物

2007年9月3日

最初の投稿 (見積もり)

2007年9月5日

学習記録の更新

投稿された最後の更新 (見積もり)

2013年12月24日

QC基準を満たした最後の更新が送信されました

2013年11月27日

最終確認日

2013年9月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

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

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

tiotropium 18 mcgの臨床試験

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スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Thailand

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

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