Tiotropium / Respimat One Year Study in COPD.

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00387088
First received: October 11, 2006
Last updated: May 7, 2014
Last verified: September 2013
  Purpose

The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Device: Respimat
Drug: Tiotropium
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Efficacy {FEV1, COPD Exacerbations & HRQoL} & Safety of 5mcg Tiotropium Respimat in COPD

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337 [ Time Frame: Baseline and Day 337 ] [ Designated as safety issue: No ]
    Trough FEV1 is defined as the FEV1 measured at the -10 min time point at the end of the dosing interval (24 h post drug administration).

  • Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    Time to first COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation.


Secondary Outcome Measures:
  • Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29 [ Time Frame: Baseline and Day 29 ] [ Designated as safety issue: No ]
    Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.

  • Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169 [ Time Frame: Baseline and Day 169 ] [ Designated as safety issue: No ]
    Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.

  • Number of COPD Exacerbations Per Patient - Exposure Adjusted [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. number of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)

  • Number of COPD Exacerbations Per Patient - naïve Estimate [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)

  • Number of Patients With at Least One COPD Exacerbation [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    Number of patients with at least one COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)

  • Time to First Hospitalisation for COPD Exacerbation [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    Time to first hospitalisation for COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation

  • Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. no. of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)

  • Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)

  • Number of Patients With at Least One Hospitalisation for a COPD Exacerbation [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    Number of patients with at least one hospitalisation for a COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)

  • Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337 [ Time Frame: Baseline and Day 337 ] [ Designated as safety issue: No ]
    The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state

  • Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169 [ Time Frame: Baseline and Day 169 ] [ Designated as safety issue: No ]
    The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state

  • Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337 [ Time Frame: Baseline and Day 337 ] [ Designated as safety issue: No ]
    The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state

  • Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169 [ Time Frame: Baseline and Day 169 ] [ Designated as safety issue: No ]
    The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state

  • Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29 [ Time Frame: Baseline and Day 29 ] [ Designated as safety issue: No ]
    Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.

  • Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169 [ Time Frame: Baseline and Day 169 ] [ Designated as safety issue: No ]
    Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.

  • Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337 [ Time Frame: Baseline and Day 337 ] [ Designated as safety issue: No ]
    Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.

  • Marked Changes From Baseline in Vital Signs at End of Treatment [ Time Frame: Baseline and end of treatment ] [ Designated as safety issue: No ]

    Marked changes from baseline in vital signs (diastolic and systolic blood pressure (DBP and SBP) and pulse rate (PR)) at end of treatment.

    SBP - Increase means SBP >150 mmHg and an increase above baseline of >25 mmHg. SBP - Decrease means SBP <100 mmHg and a decrease below baseline of >10 mmHg.

    DBP - Increase means DBP >90 mmHg and an increase above baseline of >10 mmHg. DBP - Decrease means DBP <60 mmHg and a decrease below baseline of >10 mmHg.

    PR - Increase means PR >100 bpm and an increase above baseline of >10 bpm. PR - Decrease means PR <60 bpm and a decrease below baseline of >10 bpm.


  • Clinically Relevant Findings in Physical Examination and ECG [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
    Clinically relevant findings in Physical Examination and ECG at end of treatment


Enrollment: 3991
Study Start Date: September 2006
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Tiotropium
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Drug: Tiotropium
Placebo
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Device: Respimat

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female
  2. At least 40 years old
  3. Smoker or ex-smoker
  4. Smoking history > 10 pack-years
  5. Forced Expiratory Volume in 1 Second (FEV1) < 60% predicted

Exclusion Criteria:

  1. Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
  2. History of asthma or allergic conditions.
  3. Malignancy requiring treatment within past 5 years
  4. Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
  5. Known active tuberculosis
  6. Known hypersensitivity to anticholinergic drugs.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387088

  Hide Study Locations
Locations
United States, Alabama
205.372.01020 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
205.372.01012 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
205.372.01062 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
United States, California
205.372.01048 Boehringer Ingelheim Investigational Site
Berkeley, California, United States
205.372.01037 Boehringer Ingelheim Investigational Site
Huntington Park, California, United States
205.372.01059 Boehringer Ingelheim Investigational Site
Long Beach, California, United States
205.372.01058 Boehringer Ingelheim Investigational Site
Long Beach, California, United States
205.372.01034 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
205.372.01007 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
205.372.01028 Boehringer Ingelheim Investigational Site
Rancho Mirage, California, United States
205.372.01011 Boehringer Ingelheim Investigational Site
San Diego, California, United States
United States, Colorado
205.372.01066 Boehringer Ingelheim Investigational Site
Boulder, Colorado, United States
United States, Connecticut
205.372.01008 Boehringer Ingelheim Investigational Site
Norwalk, Connecticut, United States
United States, Florida
205.372.01004 Boehringer Ingelheim Investigational Site
Brandon, Florida, United States
205.372.01060 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
205.372.01069 Boehringer Ingelheim Investigational Site
Miami Beach, Florida, United States
205.372.01023 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida, United States
205.372.01053 Boehringer Ingelheim Investigational Site
Winter Park, Florida, United States
United States, Georgia
205.372.01045 Boehringer Ingelheim Investigational Site
Calhoun, Georgia, United States
United States, Illinois
205.372.01043 Boehringer Ingelheim Investigational Site
Normal, Illinois, United States
United States, Iowa
205.372.01061 Boehringer Ingelheim Investigational Site
Dubuque, Iowa, United States
United States, Kansas
205.372.01035 Boehringer Ingelheim Investigational Site
Wichita, Kansas, United States
United States, Louisiana
205.372.01049 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana, United States
United States, Maine
205.372.01015 Boehringer Ingelheim Investigational Site
Biddeford, Maine, United States
United States, Maryland
205.372.01067 Boehringer Ingelheim Investigational Site
Columbia, Maryland, United States
205.372.01006 Boehringer Ingelheim Investigational Site
Rockville, Maryland, United States
United States, Michigan
205.372.01013 Boehringer Ingelheim Investigational Site
Detroit, Michigan, United States
United States, Minnesota
205.372.01003 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota, United States
United States, Missouri
205.372.01021 Boehringer Ingelheim Investigational Site
Chesterfield, Missouri, United States
205.372.01014 Boehringer Ingelheim Investigational Site
St. Louis, Missouri, United States
United States, Nebraska
205.372.01036 Boehringer Ingelheim Investigational Site
Omaha, Nebraska, United States
United States, New Mexico
205.372.01046 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico, United States
United States, New York
205.372.01024 Boehringer Ingelheim Investigational Site
Mineola, New York, United States
205.372.01029 Boehringer Ingelheim Investigational Site
Rochester, New York, United States
205.372.01030 Boehringer Ingelheim Investigational Site
Syracuse, New York, United States
United States, North Carolina
205.372.01026 Boehringer Ingelheim Investigational Site
Chapel Hill, North Carolina, United States
205.372.01019 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, United States
205.372.01027 Boehringer Ingelheim Investigational Site
Elizabeth City, North Carolina, United States
205.372.01038 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina, United States
205.372.01031 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina, United States
United States, Ohio
205.372.01017 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
205.372.01044 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
205.372.01041 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
United States, Oklahoma
205.372.01001 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
United States, Oregon
205.372.01063 Boehringer Ingelheim Investigational Site
Eugene, Oregon, United States
United States, Pennsylvania
205.372.01068 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
205.372.01056 Boehringer Ingelheim Investigational Site
Swathmore, Pennsylvania, United States
United States, Texas
205.372.01039 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
205.372.01050 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
205.372.01005 Boehringer Ingelheim Investigational Site
Fort Worth, Texas, United States
205.372.01018 Boehringer Ingelheim Investigational Site
Killeen, Texas, United States
205.372.01040 Boehringer Ingelheim Investigational Site
New Braunfels, Texas, United States
205.372.01052 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
United States, Virginia
205.372.01022 Boehringer Ingelheim Investigational Site
Danville, Virginia, United States
205.372.01065 Boehringer Ingelheim Investigational Site
Lynchburg, Virginia, United States
205.372.01055 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
United States, Washington
205.372.01064 Boehringer Ingelheim Investigational Site
Tacoma, Washington, United States
Australia, New South Wales
205.372.61002 Woolcock Institute of Medical Research
Glebe, New South Wales, Australia
Australia, Queensland
205.372.61009 Thoracic & General Physician
Cairns, Queensland, Australia
205.372.61005 Redcliffe Hospital
Redcliffe, Queensland, Australia
Australia, South Australia
205.372.61006 The Investigator Clinic
Port Lincoln, South Australia, Australia
205.372.61007 The Burnside War Memorial Hospital
Toorak Gardens, South Australia, Australia
205.372.61004 Boehringer Ingelheim Investigational Site
Woodville, South Australia, Australia
Australia, Victoria
205.372.61010 Ecru
Box Hill, Victoria, Australia
205.372.61008 Geelong Clinical Research Centre
Geelong, Victoria, Australia
205.372.61001 Emeritus Research
Malvern, Victoria, Australia
Australia, Western Australia
205.372.61003 Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Brazil
205.372.55012 Universidade Federal de Santa Catarina
Florianópolis, Brazil
205.372.55009 Hospital das Clínicas de Goiânia
Goiânia, Brazil
205.372.55005 Hospital Geral Otávio de Freitas
Recife, Brazil
205.372.55010 Unidade de Coracao e Pulmao do Dto. de Medicina
São Paulo - SP, Brazil
205.372.55001 INCOR e Hospital das Clínicas da Universidade de São Paulo
São Paulo - SP, Brazil
205.372.55011 CEDOES - Diagnóstico e Pesquisa
Vitória, Brazil
Canada, Alberta
205.372.11007 Heritage Medical Research Building
Calgary, Alberta, Canada
205.372.11013 Calgary West Medical Centre
Calgary, Alberta, Canada
205.372.11011 Hermitage Medicentre
Edmonton, Alberta, Canada
205.372.11017 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
205.372.11020 Wetaskiwin Lung Laboratory
Wetaskiwin, Alberta, Canada
Canada, British Columbia
205.372.11010 Dr. Kay Ho
Chilliwack, British Columbia, Canada
205.372.11018 Pacific Lung Health Centre
Vancouver, British Columbia, Canada
Canada, New Brunswick
205.372.11005 Professional Corp. Respirology
Saint John, New Brunswick, Canada
Canada, Newfoundland and Labrador
205.372.11009 White Hills Medical Clinic
St. John's, Newfoundland and Labrador, Canada
Canada, Ontario
205.372.11012 West Lincoln Memorial Hospital
Grimsby, Ontario, Canada
205.372.11014 Dr. Robert Luton
London, Ontario, Canada
205.372.11001 Niagara Clinical Research
Niagara Falls, Ontario, Canada
205.372.11019 Allergy and Asthma Research Centre
Ottawa, Ontario, Canada
205.372.11003 London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario, Canada
205.372.11016 London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario, Canada
205.372.11002 Centenary Respiratory Research Associates
Scarborough, Ontario, Canada
Canada, Quebec
205.372.11006 Clinique de médecine familiale de La Malbaie
La Malbaie, Quebec, Canada
Canada, Saskatchewan
205.372.11004 Mount Royal Family Physicians
Saskatoon, Saskatchewan, Canada
205.372.11015 Dr. Arun Nayar
Saskatoon, Saskatchewan, Canada
China
205.372.86004 Boehringer Ingelheim Investigational Site
Beijing, China
205.372.86002 Boehringer Ingelheim Investigational Site
Beijing, China
205.372.86003 Boehringer Ingelheim Investigational Site
Beijing, China
205.372.86009 Boehringer Ingelheim Investigational Site
Chengdu, Sichuan Province, China
205.372.86008 Boehringer Ingelheim Investigational Site
Chongqing, China
205.372.86001 Boehringer Ingelheim Investigational Site
Guangzhou, China
205.372.86010 Boehringer Ingelheim Investigational Site
Shanghai, China
205.372.86012 Boehringer Ingelheim Investigational Site
Shanghai, China
205.372.86011 Boehringer Ingelheim Investigational Site
Shanghai, China
205.372.86005 Boehringer Ingelheim Investigational Site
Shenyang, China
205.372.86006 Boehringer Ingelheim Investigational Site
Shenyang, China
205.372.86007 Boehringer Ingelheim Investigational Site
Wuhan, China
Denmark
205.372.45004 Boehringer Ingelheim Investigational Site
Aarhus C, Denmark
205.372.45005 Boehringer Ingelheim Investigational Site
Horsens, Denmark
205.372.45002 Boehringer Ingelheim Investigational Site
Hvidovre, Denmark
205.372.45001 Boehringer Ingelheim Investigational Site
København NV, Denmark
205.372.45003 Boehringer Ingelheim Investigational Site
Odense C, Denmark
205.372.45006 Boehringer Ingelheim Investigational Site
Silkeborg, Denmark
Finland
205.372.35804 Boehringer Ingelheim Investigational Site
Helsinki, Finland
205.372.35802 Boehringer Ingelheim Investigational Site
Jyväskylä, Finland
205.372.35803 Boehringer Ingelheim Investigational Site
Lahti, Finland
205.372.35801 Boehringer Ingelheim Investigational Site
Tampere, Finland
France
205.372.3318B Clinique du Parc
Castelnau le Lez, France
205.372.3318A Clinique du Parc
Castelnau le Lez, France
205.372.3304A Cabinet Médical
Chamalières, France
205.372.3301A Hôpital Gabriel Montpied
Clermont Ferrand cedex 1, France
205.372.3310A Centre Hospitalier
Denain, France
205.372.3314A Cabinet Médical
Grasse, France
205.372.3306A Hôpital Ambroise Paré
Marseille, France
205.372.3303A Hôpital Notre Dame de Bon Secours
Metz cedex 1, France
205.372.3303B Hôpital Notre Dame de Bon Secours
Metz cedex 1, France
205.372.3312B Cabinet Médical
Montigny les Metz, France
205.372.3312A Cabinet Médical
Montigny les Metz, France
205.372.3302A Centre Médical Erdre Saint Augustin
Nantes, France
205.372.3305B Cabinet Médical
Nice, France
205.372.3305A Cabinet Médical
Nice, France
205.372.3315B Hôpital Caremeau
Nimes cedex 9, France
205.372.3315A Hôpital Caremeau
Nîmes, France
205.372.3317A Cabinet de Pneumologie
Nîmes, France
205.372.3320B Polyclinique Les Fleurs
Ollioules, France
205.372.3320A Polyclinique Les Fleurs
Ollioules, France
205.372.3316B Clinique les Bleuets
Reims, France
205.372.3316A Clinique les Bleuets
Reims, France
205.372.3319A Institut Arnault Tzanck
Saint Laurent du Var, France
205.372.3325A Cabinet Médical
Six Four les Plages, France
205.372.3321A Centre Hospitalier
St Gaudens, France
205.372.3321C Centre Hospitalier
St Gaudens, France
205.372.3324A Cabinet Médical
Toulon, France
205.372.3309B Cabinet médical
Toulouse, France
205.372.3309A Cabinet médical
Toulouse, France
Germany
205.372.49013 Boehringer Ingelheim Investigational Site
Berlin, Germany
205.372.49002 Boehringer Ingelheim Investigational Site
Berlin, Germany
205.372.49004 Boehringer Ingelheim Investigational Site
Berlin, Germany
205.372.49007 Boehringer Ingelheim Investigational Site
Bonn, Germany
205.372.49008 Boehringer Ingelheim Investigational Site
Bruchsal, Germany
205.372.49011 Boehringer Ingelheim Investigational Site
Frankfurt/Main, Germany
205.372.49012 Boehringer Ingelheim Investigational Site
Gelnhausen, Germany
205.372.49006 Boehringer Ingelheim Investigational Site
Gütersloh, Germany
205.372.49014 Boehringer Ingelheim Investigational Site
Hannover, Germany
205.372.49005 Boehringer Ingelheim Investigational Site
Kassel, Germany
205.372.49009 Boehringer Ingelheim Investigational Site
Minden, Germany
205.372.49010 Boehringer Ingelheim Investigational Site
München, Germany
205.372.49016 Boehringer Ingelheim Investigational Site
Weinheim, Germany
205.372.49015 Boehringer Ingelheim Investigational Site
Weyhe, Germany
205.372.49001 Boehringer Ingelheim Investigational Site
Wiesloch, Germany
205.372.49003 Boehringer Ingelheim Investigational Site
Witten, Germany
Greece
205.372.30013 Boehringer Ingelheim Investigational Site
Athens, Greece
205.372.30002 Boehringer Ingelheim Investigational Site
Athens, Greece
205.372.30015 Boehringer Ingelheim Investigational Site
Athens, Greece
205.372.30003 Boehringer Ingelheim Investigational Site
Athens, Greece
205.372.30001 Boehringer Ingelheim Investigational Site
Athens, Greece
205.372.30009 Boehringer Ingelheim Investigational Site
Heraklion-Crete, Greece
205.372.30007 Boehringer Ingelheim Investigational Site
Kalamaria, Greece
205.372.30005 Boehringer Ingelheim Investigational Site
Kavala, Greece
205.372.30004 Boehringer Ingelheim Investigational Site
Komotini, Greece
205.372.30011 Boehringer Ingelheim Investigational Site
Korinthos, Greece
205.372.30019 Boehringer Ingelheim Investigational Site
Nafplio, Greece
205.372.30008 Boehringer Ingelheim Investigational Site
Serres, Greece
205.372.30006 Boehringer Ingelheim Investigational Site
Thessaloniki, Greece
205.372.30017 Boehringer Ingelheim Investigational Site
Thessaloniki, Greece
205.372.30014 Boehringer Ingelheim Investigational Site
Thiva, Greece
Hong Kong
205.372.85203 Boehringer Ingelheim Investigational Site
Hong Kong, Hong Kong
205.372.85201 Boehringer Ingelheim Investigational Site
Kowloon, Hong Kong
Hungary
205.372.36001 Boehringer Ingelheim Investigational Site
Budapest, Hungary
205.372.36002 Boehringer Ingelheim Investigational Site
Debrecen, Hungary
205.372.36004 Boehringer Ingelheim Investigational Site
Deszk, Hungary
205.372.36005 Boehringer Ingelheim Investigational Site
Erd, Hungary
205.372.36006 Boehringer Ingelheim Investigational Site
Mosonmagyarovar, Hungary
205.372.36007 Boehringer Ingelheim Investigational Site
Sopron, Hungary
India
205.372.91005 Boehringer Ingelheim Investigational Site
Andhra Pradesh, India
205.372.91016 Boehringer Ingelheim Investigational Site
Andhra Pradesh, India
205.372.91003 Boehringer Ingelheim Investigational Site
Bangalore, India
205.372.91006 Boehringer Ingelheim Investigational Site
Bangalore, India
205.372.91017 Boehringer Ingelheim Investigational Site
Calicut,Kerala, India
205.372.91010 Boehringer Ingelheim Investigational Site
Chennai, India
205.372.91007 Boehringer Ingelheim Investigational Site
Chennai, India
205.372.91002 Boehringer Ingelheim Investigational Site
Coimbatore, India
205.372.91009 Boehringer Ingelheim Investigational Site
Gujarat, India
205.372.91011 Boehringer Ingelheim Investigational Site
indore,MP, India
205.372.91012 Boehringer Ingelheim Investigational Site
Maharashtra, India
205.372.91008 Boehringer Ingelheim Investigational Site
Mumbai, India
205.372.91004 Boehringer Ingelheim Investigational Site
Mumbai, India
205.372.91015 Boehringer Ingelheim Investigational Site
New Delhi, India
205.372.91014 Boehringer Ingelheim Investigational Site
Punjab, India
205.372.91013 Boehringer Ingelheim Investigational Site
Tamil Nadu, India
205.372.91001 Boehringer Ingelheim Investigational Site
Uttar Pradesh, India
Ireland
205.372.35303 Boehringer Ingelheim Investigational Site
Mullingar, Ireland
Italy
205.372.39007 Boehringer Ingelheim Investigational Site
Bussolengo (vr), Italy
205.372.39012 Boehringer Ingelheim Investigational Site
Ferrara, Italy
205.372.39003 Boehringer Ingelheim Investigational Site
Genova, Italy
205.372.39004 Boehringer Ingelheim Investigational Site
Genova, Italy
205.372.39005 Boehringer Ingelheim Investigational Site
Milano, Italy
205.372.39008 Boehringer Ingelheim Investigational Site
Modena, Italy
205.372.39009 Boehringer Ingelheim Investigational Site
Orbassano (to), Italy
205.372.39001 Boehringer Ingelheim Investigational Site
Pisa, Italy
205.372.39010 Boehringer Ingelheim Investigational Site
Pordenone, Italy
205.372.39002 Boehringer Ingelheim Investigational Site
Prato (fi), Italy
205.372.39011 Boehringer Ingelheim Investigational Site
Roma, Italy
205.372.39006 Boehringer Ingelheim Investigational Site
Trieste, Italy
Korea, Republic of
205.372.82010 Boehringer Ingelheim Investigational Site
Anyang, Korea, Republic of
205.372.82005 Boehringer Ingelheim Investigational Site
Daegu, Korea, Republic of
205.372.82009 Boehringer Ingelheim Investigational Site
Daejoen, Korea, Republic of
205.372.82003 Boehringer Ingelheim Investigational Site
Incheon, Korea, Republic of
205.372.82008 Boehringer Ingelheim Investigational Site
Jeonbuk, Korea, Republic of
205.372.82007 Boehringer Ingelheim Investigational Site
Kwangju, Korea, Republic of
205.372.82002 Boehringer Ingelheim Investigational Site
Pusan, Korea, Republic of
205.372.82006 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
205.372.82004 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
205.372.82001 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Lithuania
205.372.37001 Boehringer Ingelheim Investigational Site
Kaunas, Lithuania
205.372.37003 Boehringer Ingelheim Investigational Site
Kaunas, Lithuania
205.372.37002 Boehringer Ingelheim Investigational Site
Vilnius, Lithuania
Malaysia
205.372.60007 Boehringer Ingelheim Investigational Site
Johor Baharu, Malaysia
205.372.60004 Boehringer Ingelheim Investigational Site
Kelantan Darul Naim, Malaysia
205.372.60005 Boehringer Ingelheim Investigational Site
Kuala Lumpur, Malaysia
205.372.60006 Boehringer Ingelheim Investigational Site
Kuala Lumpur, Malaysia
205.372.60002 Boehringer Ingelheim Investigational Site
Kuching, Sarawak, Malaysia
205.372.60003 Boehringer Ingelheim Investigational Site
Penang, Malaysia
205.372.60001 Boehringer Ingelheim Investigational Site
Selangor, Malaysia
Mexico
205.372.52018 Hospital Universitario de Chihuahua
Chihuahua, Mexico
205.372.52017 Instituto Nacional de Enfermedades Respiratorias (INER)
Col. Seccion XVI, Mexico
205.372.52013 Sanatorio Henri Dunant
Cuernavaca, Mor. México, Mexico
205.372.52005 Hospital Civil Nuevo de Guadalajara
Guadalajara, Mexico
205.372.52009 Hospital Civil Antiguo
Guadalajara Jal., Mexico
205.372.52001 Hospital General del Estado de Sonora
Hermosillo, Sonora, Mexico
205.372.52014 Hospital Angeles de las Lomas
Huixquilucan Edo.Mex., Mexico
205.372.52004 Clínica de Mérida
Merida Yuc., Mexico
205.372.52016 Hospital General de Mexicali
Mexicali Baja California Norte, Mexico
205.372.52002 Unidad de Investigación clínica en Medicina
Monterrey, Nuevo León, Mexico
205.372.52006 Hospital Universitario
Monterrey, Nuevo León, Mexico
205.372.52010 Hospital General Agustin O´Haran
Mérida Yucatán, Mexico
205.372.52012 Hospital de Nuestra Señora de la Salud
San Luis Potosi, Mexico
205.372.52003 Hospital "Angel Leaño"
Zapopan, Jal., Mexico
Netherlands
205.372.31009 Boehringer Ingelheim Investigational Site
Amsterdam, Netherlands
205.372.31006 Boehringer Ingelheim Investigational Site
Drachten, Netherlands
205.372.31001 Boehringer Ingelheim Investigational Site
Groningen, Netherlands
205.372.31011 Boehringer Ingelheim Investigational Site
Hoofddorp, Netherlands
205.372.31007 Boehringer Ingelheim Investigational Site
Leeuwarden, Netherlands
205.372.31004 Boehringer Ingelheim Investigational Site
Roosendaal, Netherlands
205.372.31003 Boehringer Ingelheim Investigational Site
Sneek, Netherlands
205.372.31012 Boehringer Ingelheim Investigational Site
Utrecht, Netherlands
205.372.31002 Boehringer Ingelheim Investigational Site
Voorburg, Netherlands
205.372.31008 Boehringer Ingelheim Investigational Site
Weerselo, Netherlands
205.372.31005 Boehringer Ingelheim Investigational Site
Winschoten, Netherlands
Norway
205.372.47001 Boehringer Ingelheim Investigational Site
Sandvika, Norway
205.372.47003 Boehringer Ingelheim Investigational Site
Trondheim, Norway
205.372.47002 Boehringer Ingelheim Investigational Site
Ålesund, Norway
Portugal
205.372.35102 Hospital Fernando Fonseca
Amadora, Portugal
205.372.35104 Hospital de Santa Marta
Lisboa, Portugal
205.372.35101 Hospital Pulido Valente
Lisboa, Portugal
205.372.35103 Hospital de São João
Porto, Portugal
205.372.35105 Centro Hospitalar do Alto Minho, Estrada de Santa Luzia
Viana do Castelo, Portugal
Singapore
205.372.65001 Boehringer Ingelheim Investigational Site
Singapore, Singapore
205.372.65003 Boehringer Ingelheim Investigational Site
Singapore, Singapore
205.372.65005 Boehringer Ingelheim Investigational Site
Singapore, Singapore
Slovakia
205.372.42102 Boehringer Ingelheim Investigational Site
Bratislava, Slovakia
205.372.42103 Boehringer Ingelheim Investigational Site
Nove Zamky, Slovakia
South Africa
205.372.27002 Boehringer Ingelheim Investigational Site
Bellville, South Africa
205.372.27001 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
205.372.27004 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
205.372.27008 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
205.372.27006 Boehringer Ingelheim Investigational Site
Centurion, South Africa
205.372.27003 Boehringer Ingelheim Investigational Site
Durban, South Africa
205.372.27005 Boehringer Ingelheim Investigational Site
Pretoria, South Africa
205.372.27007 Boehringer Ingelheim Investigational Site
Somerset West, South Africa
Spain
205.372.34005 Hospital San Pedro de Alcántara
Cáceres, Spain
205.372.34006 Hospital 12 de octubre
Madrid, Spain
205.372.34004 Hospital Gregorio Marañón
Madrid, Spain
205.372.34001 Hospital Mutua Terrassa
Terrassa (Barcelona), Spain
205.372.34002 Hospital Universitario Dr. Peset
Valencia, Spain
Sweden
205.372.46001 Björknäs Vårdcentral
Boden, Sweden
205.372.46004 Näsets läkargrupp
Höllviken, Sweden
205.372.46005 Lungmedicinska kliniken
Linköping, Sweden
205.372.46006 Lungmedicinska Kliniken
Stockholm, Sweden
205.372.46002 Alnö Vårdcentral
Sundsvall, Sweden
Switzerland
205.372.41002 Boehringer Ingelheim Investigational Site
Lugano, Switzerland
205.372.41003 Boehringer Ingelheim Investigational Site
Montana, Switzerland
205.372.41001 Boehringer Ingelheim Investigational Site
Zürich, Switzerland
Taiwan
205.372.88607 Kaohsiung Medical University Hospital
Kaohsiung, Taiwan
205.372.88606 National Cheng Kung University Hospital
Tainan, Taiwan
205.372.88602 Taipei Veterans General Hospital
Taipei, Taiwan
205.372.88604 Tri-Service General Hospital
Taipei, Taiwan
205.372.88601 National Taiwan University Hospital
Taipei, Taiwan
205.372.88603 Mackay Memorial Hospital
Taipei, Taiwan
205.372.88608 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
205.372.88609 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
205.372.88605 Chang Gung Memorial Hosp-Linkou
Taoyuan, Taiwan
Turkey
205.372.90006 Gazi Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D.
Ankara, Turkey
205.372.90007 Atatürk Gög. Hastaliklari ve Cerrahisi Egitim Hastanesi
Ankara, Turkey
205.372.90003 Uludag Universitesi Tip Fakultesi Gogus Hastaliklari
Bursa, Turkey
205.372.90009 Trakya Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D.
Edirne, Turkey
205.372.90005 Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, Turkey
205.372.90004 Dr. Lütfi Kirdar Egitim ve Arastirma Hastanesi
Istanbul, Turkey
205.372.90001 Izmir Tepecik Gogus Hastaliklari ve Gogus Cerrahisi Hast.
Izmir, Turkey
205.372.90008 Erciyes Universitesi Tip Fakultesi
Kayseri, Turkey
205.372.90010 Selcuk Universitesi Tip Fakultesi
Konya, Turkey
205.372.90002 19 Mayis Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D
Samsun, Turkey
United Kingdom
205.372.44027 Boehringer Ingelheim Investigational Site
Aston Clinton, Aylesbury, United Kingdom
205.372.44022 Boehringer Ingelheim Investigational Site
Carmarthen, United Kingdom
205.372.44002 Boehringer Ingelheim Investigational Site
Chertsey, United Kingdom
205.372.44023 Boehringer Ingelheim Investigational Site
Chesterfield, United Kingdom
205.372.44014 Boehringer Ingelheim Investigational Site
Darlington, United Kingdom
205.372.44009 Boehringer Ingelheim Investigational Site
East Horsley, United Kingdom
205.372.44011 Boehringer Ingelheim Investigational Site
Fowey, United Kingdom
205.372.44003 Boehringer Ingelheim Investigational Site
Frome, United Kingdom
205.372.44026 Boehringer Ingelheim Investigational Site
Greenisland, United Kingdom
205.372.44013 Boehringer Ingelheim Investigational Site
Heywood, United Kingdom
205.372.44016 Boehringer Ingelheim Investigational Site
Isleworth, United Kingdom
205.372.44020 Boehringer Ingelheim Investigational Site
Kirkby in Ashfield, United Kingdom
205.372.44024 Boehringer Ingelheim Investigational Site
Mortimer, United Kingdom
205.372.44001 Boehringer Ingelheim Investigational Site
Nottingham, United Kingdom
205.372.44018 Boehringer Ingelheim Investigational Site
Penzance, United Kingdom
205.372.44021 Boehringer Ingelheim Investigational Site
Plymouth, United Kingdom
205.372.44007 Boehringer Ingelheim Investigational Site
Sheffield, United Kingdom
205.372.44010 Boehringer Ingelheim Investigational Site
Sneinton, Nottingham, United Kingdom
205.372.44005 Boehringer Ingelheim Investigational Site
St Just, Penzance, United Kingdom
205.372.44015 Boehringer Ingelheim Investigational Site
St. Austell, United Kingdom
205.372.44006 Boehringer Ingelheim Investigational Site
Sunderland, United Kingdom
205.372.44008 Boehringer Ingelheim Investigational Site
Wellingborough, United Kingdom
205.372.44012 Boehringer Ingelheim Investigational Site
Westbury on Trym, United Kingdom
205.372.44028 Boehringer Ingelheim Investigational Site
Windsor, United Kingdom
205.372.44019 Boehringer Ingelheim Investigational Site
Woking, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00387088     History of Changes
Other Study ID Numbers: 205.372, 2006-001009-27
Study First Received: October 11, 2006
Results First Received: November 13, 2009
Last Updated: May 7, 2014
Health Authority: Australia: Responsilble Ethics Committee
Brazil: Ministry of Health
Canada: Health Canada - Therapeutic Products Directorate
China: Food and Drug Administration
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: AFSSAPS
Germany: BfArM Bundesinstitut fuer Arzneimittel und Medizinprodukte
Great Britain: MHRA
Greece: National Organization for Medicines (EOF) National Ethics Committee
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy, H-1051 Budapest
India: Ministry of Health and Family Welfare
Ireland: Irish Medicines Board
Italy: Comitato Etico dell'Azienda Osp. Universitaria Pisana - PISA
Korea, Republic of: Korea Food and Drug Administration (KFDA)
Lithuania: State Medicines Control Agency, LT-01132 Vilnius
Malaysia: Ministry of Health
Mexico: Ministry of Health
Netherlands: Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Portugal: National Pharmacy and Medicines Institute
Singapore: Health Sciences Authority,Ministry of Health
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
South Africa: Medicines Control Council
Spain: Ministry of Health
Sweden: The National Board of Health and Welfare
Switzerland: Swissmedic, Hallerstrasse 7, 3000 Bern
Taiwan: Department of Health, Executive Yuan, Taiwan
Turkey: Ministry of Health Central Ethics Committee
United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014