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Tiotropium / Respimat One Year Study in COPD.

7 de maio de 2014 atualizado por: Boehringer Ingelheim

Efficacy {FEV1, COPD Exacerbations & HRQoL} & Safety of 5mcg Tiotropium Respimat in COPD

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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

3991

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

40 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Modelo Intervencional: Atribuição Paralela

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: Tiotropium
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Medicamento: Tiotrópio
Outro: Placebo
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Dispositivo: Respimat

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337
Prazo: Baseline and 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
Prazo: During actual study treatment period (planned Day 1 to Day 337)
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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29
Prazo: Baseline and Day 29
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.
Baseline and Day 29
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169
Prazo: Baseline and Day 169
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.
Baseline and Day 169
Number of COPD Exacerbations Per Patient - Exposure Adjusted
Prazo: During actual study treatment period (planned Day 1 to Day 337)
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)
During actual study treatment period (planned Day 1 to Day 337)
Number of COPD Exacerbations Per Patient - naïve Estimate
Prazo: During actual study treatment period (planned Day 1 to Day 337)
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)
During actual study treatment period (planned Day 1 to Day 337)
Number of Patients With at Least One COPD Exacerbation
Prazo: During actual study treatment period (planned Day 1 to Day 337)
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)
During actual study treatment period (planned Day 1 to Day 337)
Time to First Hospitalisation for COPD Exacerbation
Prazo: During actual study treatment period (planned Day 1 to Day 337)
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
During actual study treatment period (planned Day 1 to Day 337)
Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted
Prazo: During actual study treatment period (planned Day 1 to Day 337)
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)
During actual study treatment period (planned Day 1 to Day 337)
Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate
Prazo: During actual study treatment period (planned Day 1 to Day 337)
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)
During actual study treatment period (planned Day 1 to Day 337)
Number of Patients With at Least One Hospitalisation for a COPD Exacerbation
Prazo: During actual study treatment period (planned Day 1 to Day 337)
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)
During actual study treatment period (planned Day 1 to Day 337)
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337
Prazo: Baseline and Day 337
The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Baseline and Day 337
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169
Prazo: Baseline and Day 169
The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Baseline and Day 169
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337
Prazo: Baseline and Day 337
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
Baseline and Day 337
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169
Prazo: Baseline and Day 169
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
Baseline and Day 169
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29
Prazo: Baseline and Day 29
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.
Baseline and Day 29
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169
Prazo: Baseline and Day 169
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.
Baseline and Day 169
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337
Prazo: Baseline and Day 337
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.
Baseline and Day 337
Marked Changes From Baseline in Vital Signs at End of Treatment
Prazo: Baseline and end of treatment

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.
Baseline and end of treatment
Clinically Relevant Findings in Physical Examination and ECG
Prazo: End of treatment
Clinically relevant findings in Physical Examination and ECG at end of treatment
End of treatment

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Boehringer Ingelheim

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de setembro de 2006

Conclusão Primária (Real)

1 de janeiro de 2009

Datas de inscrição no estudo

Enviado pela primeira vez

11 de outubro de 2006

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de outubro de 2006

Primeira postagem (Estimativa)

12 de outubro de 2006

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

16 de maio de 2014

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de maio de 2014

Última verificação

1 de setembro de 2013

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 205.372
  • 2006-001009-27

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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