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Tiotropium In Exercise

27. listopadu 2013 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

519

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

40 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: tiotropium 18mcg
Oral inhalation once daily of 18mcg tiotropium via handihaler
Lék: tiotropium 18 mcg
Oral inhalation once daily of 18mcg tiotropium via handihaler
Komparátor placeba: Placebo
Oral inhalation once daily of placebo matching tiotropium via handihaler
Lék: Placebo
Oral inhalation of once-daily placebo matching tiotropium via handihaler

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase
Časové okno: baseline, 96 weeks
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
baseline, 96 weeks

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Boehringer Ingelheim

Spolupracovníci

Pfizer

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

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Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. srpna 2007

Primární dokončení (Aktuální)

1. června 2010

Termíny zápisu do studia

První předloženo

3. září 2007

První předloženo, které splnilo kritéria kontroly kvality

3. září 2007

První zveřejněno (Odhad)

5. září 2007

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

24. prosince 2013

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

27. listopadu 2013

Naposledy ověřeno

1. září 2013

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na tiotropium 18 mcg

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Podmínky

Vzácné nemoci

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Místa

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