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Tiotropium / Respimat One Year Study in COPD.

7 maja 2014 zaktualizowane przez: 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.

Przegląd badań

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

3991

Faza

  • Faza 3

Kontakty i lokalizacje

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

Lokalizacje studiów

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

Kryteria uczestnictwa

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

Kryteria kwalifikacji

Wiek uprawniający do nauki

40 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  1. 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.

Plan studiów

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

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Model interwencyjny: Przydział równoległy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Inny: Tiotropium
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Inny: Placebo
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337
Ramy czasowe: 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
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: End of treatment
Clinically relevant findings in Physical Examination and ECG at end of treatment
End of treatment

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Publikacje i pomocne linki

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

Daty zapisu na studia

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

Główne daty studiów

Rozpoczęcie studiów

1 września 2006

Zakończenie podstawowe (Rzeczywisty)

1 stycznia 2009

Daty rejestracji na studia

Pierwszy przesłany

11 października 2006

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 października 2006

Pierwszy wysłany (Oszacować)

12 października 2006

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

16 maja 2014

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

7 maja 2014

Ostatnia weryfikacja

1 września 2013

Więcej informacji

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

Badania kliniczne na Choroba płuc, przewlekła obturacja

Badania kliniczne na Tiotropium

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