Tiotropium / Respimat One Year Study in COPD.

NCT00387088 | Completed Phase 3 Results

• 2 other identifiers: 205.3722006-001009-27
• Study Type: interventional
• Target: 3,991
• Locations: 31 countries
• Sites: 334

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337

  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).

  Baseline and Day 337

• Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

  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.

  During actual study treatment period (planned Day 1 to Day 337)

Secondary Outcomes (18)

• Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29

  Baseline and Day 29

• Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169

  Baseline and Day 169

• Number of COPD Exacerbations Per Patient - Exposure Adjusted

  During actual study treatment period (planned Day 1 to Day 337)

• Number of COPD Exacerbations Per Patient - naïve Estimate

  During actual study treatment period (planned Day 1 to Day 337)

• Number of Patients With at Least One COPD Exacerbation

  During actual study treatment period (planned Day 1 to Day 337)

Study Arms (2)

Tiotropium

OTHER

Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Drug: Tiotropium

Placebo

OTHER

Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Device: Respimat

Interventions

Respimat DEVICE

Placebo

Tiotropium DRUG

Tiotropium

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
• History of asthma or allergic conditions.
• Malignancy requiring treatment within past 5 years
• Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
• Known active tuberculosis
• Known hypersensitivity to anticholinergic drugs.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (334)

205.372.01012 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

205.372.01020 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

205.372.01062 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

205.372.01048 Boehringer Ingelheim Investigational Site

Berkeley, California, United States

Location

205.372.01037 Boehringer Ingelheim Investigational Site

Huntington Park, California, United States

Location

205.372.01058 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Location

205.372.01059 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Location

205.372.01007 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

205.372.01034 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

205.372.01028 Boehringer Ingelheim Investigational Site

Rancho Mirage, California, United States

Location

205.372.01011 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

205.372.01066 Boehringer Ingelheim Investigational Site

Boulder, Colorado, United States

Location

205.372.01008 Boehringer Ingelheim Investigational Site

Norwalk, Connecticut, United States

Location

205.372.01004 Boehringer Ingelheim Investigational Site

Brandon, Florida, United States

Location

205.372.01060 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

205.372.01069 Boehringer Ingelheim Investigational Site

Miami Beach, Florida, United States

Location

205.372.01023 Boehringer Ingelheim Investigational Site

West Palm Beach, Florida, United States

Location

205.372.01053 Boehringer Ingelheim Investigational Site

Winter Park, Florida, United States

Location

205.372.01045 Boehringer Ingelheim Investigational Site

Calhoun, Georgia, United States

Location

205.372.01043 Boehringer Ingelheim Investigational Site

Normal, Illinois, United States

Location

205.372.01061 Boehringer Ingelheim Investigational Site

Dubuque, Iowa, United States

Location

205.372.01035 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

Location

205.372.01049 Boehringer Ingelheim Investigational Site

Shreveport, Louisiana, United States

Location

205.372.01015 Boehringer Ingelheim Investigational Site

Biddeford, Maine, United States

Location

205.372.01067 Boehringer Ingelheim Investigational Site

Columbia, Maryland, United States

Location

205.372.01006 Boehringer Ingelheim Investigational Site

Rockville, Maryland, United States

Location

205.372.01013 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

Location

205.372.01003 Boehringer Ingelheim Investigational Site

Minneapolis, Minnesota, United States

Location

205.372.01021 Boehringer Ingelheim Investigational Site

Chesterfield, Missouri, United States

Location

205.372.01014 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

205.372.01036 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Location

205.372.01046 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Location

205.372.01024 Boehringer Ingelheim Investigational Site

Mineola, New York, United States

Location

205.372.01029 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

Location

205.372.01030 Boehringer Ingelheim Investigational Site

Syracuse, New York, United States

Location

205.372.01026 Boehringer Ingelheim Investigational Site

Chapel Hill, North Carolina, United States

Location

205.372.01019 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Location

205.372.01027 Boehringer Ingelheim Investigational Site

Elizabeth City, North Carolina, United States

Location

205.372.01038 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

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205.372.01031 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

205.372.01017 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

205.372.01041 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

205.372.01044 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

205.372.01001 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

205.372.01063 Boehringer Ingelheim Investigational Site

Eugene, Oregon, United States

Location

205.372.01068 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

205.372.01056 Boehringer Ingelheim Investigational Site

Swathmore, Pennsylvania, United States

Location

205.372.01039 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

205.372.01050 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

205.372.01005 Boehringer Ingelheim Investigational Site

Fort Worth, Texas, United States

Location

205.372.01018 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

Location

205.372.01040 Boehringer Ingelheim Investigational Site

New Braunfels, Texas, United States

Location

205.372.01052 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

205.372.01022 Boehringer Ingelheim Investigational Site

Danville, Virginia, United States

Location

205.372.01065 Boehringer Ingelheim Investigational Site

Lynchburg, Virginia, United States

Location

205.372.01055 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

205.372.01064 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Location

205.372.61002 Woolcock Institute of Medical Research

Glebe, New South Wales, Australia

Location

205.372.61009 Thoracic & General Physician

Cairns, Queensland, Australia

Location

205.372.61005 Redcliffe Hospital

Redcliffe, Queensland, Australia

Location

205.372.61006 The Investigator Clinic

Port Lincoln, South Australia, Australia

Location

205.372.61007 The Burnside War Memorial Hospital

Toorak Gardens, South Australia, Australia

Location

205.372.61004 Boehringer Ingelheim Investigational Site

Woodville, South Australia, Australia

Location

205.372.61010 Ecru

Box Hill, Victoria, Australia

Location

205.372.61008 Geelong Clinical Research Centre

Geelong, Victoria, Australia

Location

205.372.61001 Emeritus Research

Malvern, Victoria, Australia

Location

205.372.61003 Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Location

205.372.55012 Universidade Federal de Santa Catarina

Florianópolis, Brazil

Location

205.372.55009 Hospital das Clínicas de Goiânia

Goiânia, Brazil

Location

205.372.55005 Hospital Geral Otávio de Freitas

Recife, Brazil

Location

205.372.55001 INCOR e Hospital das Clínicas da Universidade de São Paulo

São Paulo - SP, Brazil

Location

205.372.55010 Unidade de Coracao e Pulmao do Dto. de Medicina

São Paulo - SP, Brazil

Location

205.372.55011 CEDOES - Diagnóstico e Pesquisa

Vitória, Brazil

Location

205.372.11007 Heritage Medical Research Building

Calgary, Alberta, Canada

Location

205.372.11013 Calgary West Medical Centre

Calgary, Alberta, Canada

Location

205.372.11011 Hermitage Medicentre

Edmonton, Alberta, Canada

Location

205.372.11017 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Location

205.372.11020 Wetaskiwin Lung Laboratory

Wetaskiwin, Alberta, Canada

Location

205.372.11010 Dr. Kay Ho

Chilliwack, British Columbia, Canada

Location

205.372.11018 Pacific Lung Health Centre

Vancouver, British Columbia, Canada

Location

205.372.11005 Professional Corp. Respirology

Saint John, New Brunswick, Canada

Location

205.372.11009 White Hills Medical Clinic

St. John's, Newfoundland and Labrador, Canada

Location

205.372.11012 West Lincoln Memorial Hospital

Grimsby, Ontario, Canada

Location

205.372.11014 Dr. Robert Luton

London, Ontario, Canada

Location

205.372.11001 Niagara Clinical Research

Niagara Falls, Ontario, Canada

Location

205.372.11019 Allergy and Asthma Research Centre

Ottawa, Ontario, Canada

Location

205.372.11003 London Road Diagnostic Clinic and Medical Centre

Sarnia, Ontario, Canada

Location

205.372.11016 London Road Diagnostic Clinic and Medical Centre

Sarnia, Ontario, Canada

Location

205.372.11002 Centenary Respiratory Research Associates

Scarborough Village, Ontario, Canada

Location

205.372.11006 Clinique de médecine familiale de La Malbaie

La Malbaie, Quebec, Canada

Location

205.372.11004 Mount Royal Family Physicians

Saskatoon, Saskatchewan, Canada

Location

205.372.11015 Dr. Arun Nayar

Saskatoon, Saskatchewan, Canada

Location

205.372.86002 Boehringer Ingelheim Investigational Site

Beijing, China

Location

205.372.86003 Boehringer Ingelheim Investigational Site

Beijing, China

Location

205.372.86004 Boehringer Ingelheim Investigational Site

Beijing, China

Location

205.372.86009 Boehringer Ingelheim Investigational Site

Chengdu, Sichuan Province, China

Location

205.372.86008 Boehringer Ingelheim Investigational Site

Chongqing, China

Location

205.372.86001 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

205.372.86010 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

205.372.86011 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

205.372.86012 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

205.372.86005 Boehringer Ingelheim Investigational Site

Shenyang, China

Location

205.372.86006 Boehringer Ingelheim Investigational Site

Shenyang, China

Location

205.372.86007 Boehringer Ingelheim Investigational Site

Wuhan, China

Location

205.372.45004 Boehringer Ingelheim Investigational Site

Aarhus C, Denmark

Location

205.372.45005 Boehringer Ingelheim Investigational Site

Horsens, Denmark

Location

205.372.45002 Boehringer Ingelheim Investigational Site

Hvidovre, Denmark

Location

205.372.45001 Boehringer Ingelheim Investigational Site

København NV, Denmark

Location

205.372.45003 Boehringer Ingelheim Investigational Site

Odense C, Denmark

Location

205.372.45006 Boehringer Ingelheim Investigational Site

Silkeborg, Denmark

Location

205.372.35804 Boehringer Ingelheim Investigational Site

Helsinki, Finland

Location

205.372.35802 Boehringer Ingelheim Investigational Site

Jyväskylä, Finland

Location

205.372.35803 Boehringer Ingelheim Investigational Site

Lahti, Finland

Location

205.372.35801 Boehringer Ingelheim Investigational Site

Tampere, Finland

Location

205.372.3318A Clinique du Parc

Castelnau-le-Lez, France

Location

205.372.3318B Clinique du Parc

Castelnau-le-Lez, France

Location

205.372.3304A Cabinet Médical

Chamalières, France

Location

205.372.3301A Hôpital Gabriel Montpied

Clermont-Ferrand, France

Location

205.372.3310A Centre Hospitalier

Denain, France

Location

205.372.3314A Cabinet Médical

Grasse, France

Location

205.372.3306A Hôpital Ambroise Paré

Marseille, France

Location

205.372.3303A Hôpital Notre Dame de Bon Secours

Metz, France

Location

205.372.3303B Hôpital Notre Dame de Bon Secours

Metz, France

Location

205.372.3312A Cabinet Médical

Montigny-lès-Metz, France

Location

205.372.3312B Cabinet Médical

Montigny-lès-Metz, France

Location

205.372.3302A Centre Médical Erdre Saint Augustin

Nantes, France

Location

205.372.3305A Cabinet Médical

Nice, France

Location

205.372.3305B Cabinet Médical

Nice, France

Location

205.372.3315A Hôpital Caremeau

Nîmes, France

Location

205.372.3315B Hôpital Caremeau

Nîmes, France

Location

205.372.3317A Cabinet de Pneumologie

Nîmes, France

Location

205.372.3320A Polyclinique Les Fleurs

Ollioules, France

Location

205.372.3320B Polyclinique Les Fleurs

Ollioules, France

Location

205.372.3316A Clinique les Bleuets

Reims, France

Location

205.372.3316B Clinique les Bleuets

Reims, France

Location

205.372.3321A Centre Hospitalier

Saint-Gaudens, France

Location

205.372.3321C Centre Hospitalier

Saint-Gaudens, France

Location

205.372.3319A Institut Arnault Tzanck

Saint-Laurent-du-Var, France

Location

205.372.3325A Cabinet Médical

Six Four Les Plages, France

Location

205.372.3324A Cabinet Médical

Toulon, France

Location

205.372.3309A Cabinet médical

Toulouse, France

Location

205.372.3309B Cabinet médical

Toulouse, France

Location

205.372.49002 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

205.372.49004 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

205.372.49013 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

205.372.49007 Boehringer Ingelheim Investigational Site

Bonn, Germany

Location

205.372.49008 Boehringer Ingelheim Investigational Site

Bruchsal, Germany

Location

205.372.49011 Boehringer Ingelheim Investigational Site

Frankfurt am Main, Germany

Location

205.372.49012 Boehringer Ingelheim Investigational Site

Gelnhausen, Germany

Location

205.372.49006 Boehringer Ingelheim Investigational Site

Gütersloh, Germany

Location

205.372.49014 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

205.372.49005 Boehringer Ingelheim Investigational Site

Kassel, Germany

Location

205.372.49009 Boehringer Ingelheim Investigational Site

Minden, Germany

Location

205.372.49010 Boehringer Ingelheim Investigational Site

München, Germany

Location

205.372.49016 Boehringer Ingelheim Investigational Site

Weinheim, Germany

Location

205.372.49015 Boehringer Ingelheim Investigational Site

Weyhe, Germany

Location

205.372.49001 Boehringer Ingelheim Investigational Site

Wiesloch, Germany

Location

205.372.49003 Boehringer Ingelheim Investigational Site

Witten, Germany

Location

205.372.30001 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

205.372.30002 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

205.372.30003 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

205.372.30013 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

205.372.30015 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

205.372.30011 Boehringer Ingelheim Investigational Site

Corinth, Greece

Location

205.372.30009 Boehringer Ingelheim Investigational Site

Heraklion-Crete, Greece

Location

205.372.30007 Boehringer Ingelheim Investigational Site

Kalamaria, Greece

Location

205.372.30005 Boehringer Ingelheim Investigational Site

Kavala, Greece

Location

205.372.30004 Boehringer Ingelheim Investigational Site

Komotini, Greece

Location

205.372.30019 Boehringer Ingelheim Investigational Site

Nafplion, Greece

Location

205.372.30008 Boehringer Ingelheim Investigational Site

Serres, Greece

Location

205.372.30014 Boehringer Ingelheim Investigational Site

Thebes, Greece

Location

205.372.30006 Boehringer Ingelheim Investigational Site

Thessaloniki, Greece

Location

205.372.30017 Boehringer Ingelheim Investigational Site

Thessaloniki, Greece

Location

205.372.85203 Boehringer Ingelheim Investigational Site

Hong Kong, Hong Kong

Location

205.372.85201 Boehringer Ingelheim Investigational Site

Kowloon, Hong Kong

Location

205.372.36001 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

205.372.36002 Boehringer Ingelheim Investigational Site

Debrecen, Hungary

Location

205.372.36004 Boehringer Ingelheim Investigational Site

Deszk, Hungary

Location

205.372.36005 Boehringer Ingelheim Investigational Site

Érd, Hungary

Location

205.372.36006 Boehringer Ingelheim Investigational Site

Mosonmagyaróvár, Hungary

Location

205.372.36007 Boehringer Ingelheim Investigational Site

Sopron, Hungary

Location

205.372.91005 Boehringer Ingelheim Investigational Site

Andhra Pradesh, India

Location

205.372.91016 Boehringer Ingelheim Investigational Site

Andhra Pradesh, India

Location

205.372.91003 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

205.372.91006 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

205.372.91017 Boehringer Ingelheim Investigational Site

Calicut,Kerala, India

Location

205.372.91007 Boehringer Ingelheim Investigational Site

Chennai, India

Location

205.372.91010 Boehringer Ingelheim Investigational Site

Chennai, India

Location

205.372.91002 Boehringer Ingelheim Investigational Site

Coimbatore, India

Location

205.372.91009 Boehringer Ingelheim Investigational Site

Gujarat, India

Location

205.372.91011 Boehringer Ingelheim Investigational Site

indore,MP, India

Location

205.372.91012 Boehringer Ingelheim Investigational Site

Maharashtra, India

Location

205.372.91004 Boehringer Ingelheim Investigational Site

Mumbai, India

Location

205.372.91008 Boehringer Ingelheim Investigational Site

Mumbai, India

Location

205.372.91015 Boehringer Ingelheim Investigational Site

New Delhi, India

Location

205.372.91014 Boehringer Ingelheim Investigational Site

Punjab, India

Location

205.372.91013 Boehringer Ingelheim Investigational Site

Tamil Nadu, India

Location

205.372.91001 Boehringer Ingelheim Investigational Site

Uttar Pradesh, India

Location

205.372.35303 Boehringer Ingelheim Investigational Site

Mullingar, Ireland

Location

205.372.39007 Boehringer Ingelheim Investigational Site

Bussolengo (vr), Italy

Location

205.372.39012 Boehringer Ingelheim Investigational Site

Ferrara, Italy

Location

205.372.39003 Boehringer Ingelheim Investigational Site

Genova, Italy

Location

205.372.39004 Boehringer Ingelheim Investigational Site

Genova, Italy

Location

205.372.39005 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

205.372.39008 Boehringer Ingelheim Investigational Site

Modena, Italy

Location

205.372.39009 Boehringer Ingelheim Investigational Site

Orbassano (to), Italy

Location

205.372.39001 Boehringer Ingelheim Investigational Site

Pisa, Italy

Location

205.372.39010 Boehringer Ingelheim Investigational Site

Pordenone, Italy

Location

205.372.39002 Boehringer Ingelheim Investigational Site

Prato (fi), Italy

Location

205.372.39011 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

205.372.39006 Boehringer Ingelheim Investigational Site

Trieste, Italy

Location

205.372.37001 Boehringer Ingelheim Investigational Site

Kaunas, Lithuania

Location

205.372.37003 Boehringer Ingelheim Investigational Site

Kaunas, Lithuania

Location

205.372.37002 Boehringer Ingelheim Investigational Site

Vilnius, Lithuania

Location

205.372.60003 Boehringer Ingelheim Investigational Site

George Town, Malaysia

Location

205.372.60007 Boehringer Ingelheim Investigational Site

Johor Bahru, Malaysia

Location

205.372.60004 Boehringer Ingelheim Investigational Site

Kelantan Darul Naim, Malaysia

Location

205.372.60005 Boehringer Ingelheim Investigational Site

Kuala Lumpur, Malaysia

Location

205.372.60006 Boehringer Ingelheim Investigational Site

Kuala Lumpur, Malaysia

Location

205.372.60001 Boehringer Ingelheim Investigational Site

Kuala Selangor, Malaysia

Location

205.372.60002 Boehringer Ingelheim Investigational Site

Kuching, Sarawak, Malaysia

Location

205.372.52018 Hospital Universitario de Chihuahua

Chihuahua City, Mexico

Location

205.372.52017 Instituto Nacional de Enfermedades Respiratorias (INER)

Col. Seccion XVI, Mexico

Location

205.372.52013 Sanatorio Henri Dunant

Cuernavaca, Mor. México, Mexico

Location

205.372.52005 Hospital Civil Nuevo de Guadalajara

Guadalajara, Mexico

Location

205.372.52009 Hospital Civil Antiguo

Guadalajara Jal., Mexico

Location

205.372.52001 Hospital General del Estado de Sonora

Hermosillo, Sonora, Mexico

Location

205.372.52014 Hospital Angeles de las Lomas

Huixquilucan Edo.Mex., Mexico

Location

205.372.52004 Clínica de Mérida

Merida Yuc., Mexico

Location

205.372.52016 Hospital General de Mexicali

Mexicali Baja California Norte, Mexico

Location

205.372.52010 Hospital General Agustin O´Haran

Mérida Yucatán, Mexico

Location

205.372.52002 Unidad de Investigación clínica en Medicina

Monterrey, Nuevo León, Mexico

Location

205.372.52006 Hospital Universitario

Monterrey, Nuevo León, Mexico

Location

205.372.52012 Hospital de Nuestra Señora de la Salud

San Luis Potosí City, Mexico

Location

205.372.52003 Hospital "Angel Leaño"

Zapopan, Jal., Mexico

Location

205.372.31009 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

Location

205.372.31006 Boehringer Ingelheim Investigational Site

Drachten, Netherlands

Location

205.372.31001 Boehringer Ingelheim Investigational Site

Groningen, Netherlands

Location

205.372.31011 Boehringer Ingelheim Investigational Site

Hoofddorp, Netherlands

Location

205.372.31007 Boehringer Ingelheim Investigational Site

Leeuwarden, Netherlands

Location

205.372.31004 Boehringer Ingelheim Investigational Site

Roosendaal, Netherlands

Location

205.372.31003 Boehringer Ingelheim Investigational Site

Sneek, Netherlands

Location

205.372.31012 Boehringer Ingelheim Investigational Site

Utrecht, Netherlands

Location

205.372.31002 Boehringer Ingelheim Investigational Site

Voorburg, Netherlands

Location

205.372.31008 Boehringer Ingelheim Investigational Site

Weerselo, Netherlands

Location

205.372.31005 Boehringer Ingelheim Investigational Site

Winschoten, Netherlands

Location

205.372.47002 Boehringer Ingelheim Investigational Site

Ålesund, Norway

Location

205.372.47001 Boehringer Ingelheim Investigational Site

Sandvika, Norway

Location

205.372.47003 Boehringer Ingelheim Investigational Site

Trondheim, Norway

Location

205.372.35102 Hospital Fernando Fonseca

Amadora, Portugal

Location

205.372.35101 Hospital Pulido Valente

Lisbon, Portugal

Location

205.372.35104 Hospital de Santa Marta

Lisbon, Portugal

Location

205.372.35103 Hospital de São João

Porto, Portugal

Location

205.372.35105 Centro Hospitalar do Alto Minho, Estrada de Santa Luzia

Viana do Castelo, Portugal

Location

205.372.65001 Boehringer Ingelheim Investigational Site

Singapore, Singapore

Location

205.372.65003 Boehringer Ingelheim Investigational Site

Singapore, Singapore

Location

205.372.65005 Boehringer Ingelheim Investigational Site

Singapore, Singapore

Location

205.372.42102 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

205.372.42103 Boehringer Ingelheim Investigational Site

Nové Zámky, Slovakia

Location

205.372.27002 Boehringer Ingelheim Investigational Site

Bellville, South Africa

Location

205.372.27001 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

205.372.27004 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

205.372.27008 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

205.372.27006 Boehringer Ingelheim Investigational Site

Centurion, South Africa

Location

205.372.27003 Boehringer Ingelheim Investigational Site

Durban, South Africa

Location

205.372.27005 Boehringer Ingelheim Investigational Site

Pretoria, South Africa

Location

205.372.27007 Boehringer Ingelheim Investigational Site

Somerset West, South Africa

Location

205.372.82010 Boehringer Ingelheim Investigational Site

Anyang, South Korea

Location

205.372.82005 Boehringer Ingelheim Investigational Site

Daegu, South Korea

Location

205.372.82009 Boehringer Ingelheim Investigational Site

Daejoen, South Korea

Location

205.372.82003 Boehringer Ingelheim Investigational Site

Incheon, South Korea

Location

205.372.82008 Boehringer Ingelheim Investigational Site

Jeonbuk, South Korea

Location

205.372.82007 Boehringer Ingelheim Investigational Site

Kwangju, South Korea

Location

205.372.82002 Boehringer Ingelheim Investigational Site

Pusan, South Korea

Location

205.372.82001 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

205.372.82004 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

205.372.82006 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

205.372.34005 Hospital San Pedro de Alcántara

Cáceres, Spain

Location

205.372.34004 Hospital Gregorio Marañón

Madrid, Spain

Location

205.372.34006 Hospital 12 de octubre

Madrid, Spain

Location

205.372.34001 Hospital Mutua Terrassa

Terrassa (Barcelona), Spain

Location

205.372.34002 Hospital Universitario Dr. Peset

Valencia, Spain

Location

205.372.46001 Björknäs Vårdcentral

Boden, Sweden

Location

205.372.46004 Näsets läkargrupp

Höllviken, Sweden

Location

205.372.46005 Lungmedicinska kliniken

Linköping, Sweden

Location

205.372.46006 Lungmedicinska Kliniken

Stockholm, Sweden

Location

205.372.46002 Alnö Vårdcentral

Sundsvall, Sweden

Location

205.372.41002 Boehringer Ingelheim Investigational Site

Lugano, Switzerland

Location

205.372.41003 Boehringer Ingelheim Investigational Site

Montana, Switzerland

Location

205.372.41001 Boehringer Ingelheim Investigational Site

Zurich, Switzerland

Location

205.372.88607 Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Location

205.372.88606 National Cheng Kung University Hospital

Tainan, Taiwan

Location

205.372.88601 National Taiwan University Hospital

Taipei, Taiwan

Location

205.372.88602 Taipei Veterans General Hospital

Taipei, Taiwan

Location

205.372.88603 Mackay Memorial Hospital

Taipei, Taiwan

Location

205.372.88604 Tri-Service General Hospital

Taipei, Taiwan

Location

205.372.88608 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

205.372.88609 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

205.372.88605 Chang Gung Memorial Hosp-Linkou

Taoyuan District, Taiwan

Location

205.372.90006 Gazi Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D.

Ankara, Turkey (Türkiye)

Location

205.372.90007 Atatürk Gög. Hastaliklari ve Cerrahisi Egitim Hastanesi

Ankara, Turkey (Türkiye)

Location

205.372.90003 Uludag Universitesi Tip Fakultesi Gogus Hastaliklari

Bursa, Turkey (Türkiye)

Location

205.372.90009 Trakya Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D.

Edirne, Turkey (Türkiye)

Location

205.372.90004 Dr. Lütfi Kirdar Egitim ve Arastirma Hastanesi

Istanbul, Turkey (Türkiye)

Location

205.372.90005 Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, Turkey (Türkiye)

Location

205.372.90001 Izmir Tepecik Gogus Hastaliklari ve Gogus Cerrahisi Hast.

Izmir, Turkey (Türkiye)

Location

205.372.90008 Erciyes Universitesi Tip Fakultesi

Kayseri, Turkey (Türkiye)

Location

205.372.90010 Selcuk Universitesi Tip Fakultesi

Konya, Turkey (Türkiye)

Location

205.372.90002 19 Mayis Universitesi Tip Fakultesi Gogus Hastaliklari A.B.D

Samsun, Turkey (Türkiye)

Location

205.372.44027 Boehringer Ingelheim Investigational Site

Aston Clinton, Aylesbury, United Kingdom

Location

205.372.44022 Boehringer Ingelheim Investigational Site

Carmarthen, United Kingdom

Location

205.372.44002 Boehringer Ingelheim Investigational Site

Chertsey, United Kingdom

Location

205.372.44023 Boehringer Ingelheim Investigational Site

Chesterfield, United Kingdom

Location

205.372.44014 Boehringer Ingelheim Investigational Site

Darlington, United Kingdom

Location

205.372.44009 Boehringer Ingelheim Investigational Site

East Horsley, United Kingdom

Location

205.372.44011 Boehringer Ingelheim Investigational Site

Fowey, United Kingdom

Location

205.372.44003 Boehringer Ingelheim Investigational Site

Frome, United Kingdom

Location

205.372.44026 Boehringer Ingelheim Investigational Site

Greenisland, United Kingdom

Location

205.372.44013 Boehringer Ingelheim Investigational Site

Heywood, United Kingdom

Location

205.372.44016 Boehringer Ingelheim Investigational Site

Isleworth, United Kingdom

Location

205.372.44020 Boehringer Ingelheim Investigational Site

Kirkby in Ashfield, United Kingdom

Location

205.372.44024 Boehringer Ingelheim Investigational Site

Mortimer, United Kingdom

Location

205.372.44001 Boehringer Ingelheim Investigational Site

Nottingham, United Kingdom

Location

205.372.44018 Boehringer Ingelheim Investigational Site

Penzance, United Kingdom

Location

205.372.44021 Boehringer Ingelheim Investigational Site

Plymouth, United Kingdom

Location

205.372.44005 Boehringer Ingelheim Investigational Site

Saint Just, Penzance, United Kingdom

Location

205.372.44007 Boehringer Ingelheim Investigational Site

Sheffield, United Kingdom

Location

205.372.44010 Boehringer Ingelheim Investigational Site

Sneinton, Nottingham, United Kingdom

Location

205.372.44015 Boehringer Ingelheim Investigational Site

St Austell, United Kingdom

Location

205.372.44006 Boehringer Ingelheim Investigational Site

Sunderland, United Kingdom

Location

205.372.44008 Boehringer Ingelheim Investigational Site

Wellingborough, United Kingdom

Location

205.372.44012 Boehringer Ingelheim Investigational Site

Westbury on Trym, United Kingdom

Location

205.372.44028 Boehringer Ingelheim Investigational Site

Windsor, United Kingdom

Location

205.372.44019 Boehringer Ingelheim Investigational Site

Woking, United Kingdom

Location

Related Publications (2)

• Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.

  PMID: 32943047 DERIVED

• Bateman ED, Tashkin D, Siafakas N, Dahl R, Towse L, Massey D, Pavia D, Zhong NS. A one-year trial of tiotropium Respimat plus usual therapy in COPD patients. Respir Med. 2010 Oct;104(10):1460-72. doi: 10.1016/j.rmed.2010.06.004.

  PMID: 20620037 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Pharmaceuticals
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 11, 2006
• First Posted: October 12, 2006
• Study Start: September 1, 2006
• Primary Completion: January 1, 2009
• Last Updated: May 16, 2014
• Results First Posted: January 22, 2010

Record last verified: 2013-09

Locations

IN (17); LI (3); ZA (8); HU (6); SL (2); DK (6); FI (4); CN (12); GR (15); TU (10); KR (10); FR (28); NO (3); HK (2); TW (9); DE (16); US (57); ME (14); MY (7); CA (19); BR (6); SG (3); PT (5); GB (25); IT (12); AU (10); ES (5); NL (11); SE (5); CH (3); IE (1)