Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Tiotropium In Exercise

27 listopada 2013 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

519

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

40 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: tiotropium 18mcg
Oral inhalation once daily of 18mcg tiotropium via handihaler
Lek: tiotropium 18 mcg
Oral inhalation once daily of 18mcg tiotropium via handihaler
Komparator placebo: Placebo
Oral inhalation once daily of placebo matching tiotropium via handihaler
Lek: Placebo
Oral inhalation of once-daily placebo matching tiotropium via handihaler

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase
Ramy czasowe: baseline, 96 weeks
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
baseline, 96 weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Boehringer Ingelheim

Współpracownicy

Pfizer

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 sierpnia 2007

Zakończenie podstawowe (Rzeczywisty)

1 czerwca 2010

Daty rejestracji na studia

Pierwszy przesłany

3 września 2007

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 września 2007

Pierwszy wysłany (Oszacować)

5 września 2007

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

24 grudnia 2013

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 listopada 2013

Ostatnia weryfikacja

1 września 2013

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

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

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Choroba płuc, przewlekła obturacja

Badania kliniczne na tiotropium 18 mcg

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Ghana

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

Subskrybuj