Respimat Combivent Trial in COPD

Condition(s) targeted: Pulmonary Disease, Chronic Obstructive

Intervention: Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI (Drug); COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat (Drug); Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals

The primary objective of this study is to compare the effect of ipratropium bromide/salbutamol inhalation spray combination administered by the Respimat? inhaler (20 mcg/100 mcg), ipratropium bromide inhalation spray administered by the Respimat? inhaler (20 mcg), and COMBIVENT? MDI administered q. i.d on FEV1 at intervals over a treatment period of 12 weeks in patients with COPD. Specifically, non-inferiority of Combivent Respimat? to COMBIVENT? MDI in FEV1 AUC from 0 to 6 hours , superiority of Combivent Respimat? to Atrovent Respimat? monotherapy in FEV1 AUC from 0 to 4 hours, and non-inferiority of Combivent Respimat? to Atrovent Respimat? monotherapy in FEV1 AUC from 4 to 6 hours will b e analyzed. In addition, steady state pharmacokinetics over one dosing interval following 4 weeks of therapy will be characterized in a subgroup of patients.

Official title: Safety and Efficacy of Combivent Respimat in COPD

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment

Primary outcome: There are three co-primary endpoints: (1) FEV1 AUC (0-6) Combivent Respimat? compared to COMBIVENT? MDI (2) FEV1 AUC (0-4) Combivent Respimat? compared to Atrovent Respimat? (3) FEV1 AUC (4-6) Combivent Respimat? compared to Atrovent Respimat

Secondary outcome: (1) AM Peak Flow, (2) Beta agonist and steroid use, (3) COPD Daily Symptom Scores, (4) Physician Global Assessment (PGA) and (5) COPD Exacerbations.

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

Outpatients of either sex, 40 years or older, with a diagnosis of COPD (FEV1 65% predicted normal and FEV1/FVC 70%).

Exclusion Criteria:

Patients with significant diseases other than COPD that may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study, with a history of asthma or allergic rhinitis, who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator?s opinion will be unable to abstain from the use of oxygen therapy or using oral corticosteroid me dication at unstable doses (i. e., less than 6 weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day will be excluded.

Boehringer Ingelheim Investigational Site, Buenos Airess, Argentina

Boehringer Ingelheim Investigational Site, Capital Federal ,Buenos Aires, Argentina

Policlinica Bancaria, Buenos Aires, Argentina

Hospital Ramos Mejia, Capital Federal, Argentina

Boehringer Ingelheim Investigational Site, La Plata, Buenos Aires, Argentina

Boehringer Ingelheim Investigational Site, Parana, Argentina

Boehringer Ingelheim Investigational Site, Monte Grande, Argentina

HOSPITAL ITALIANO de ROSARIO, Rosario, Argentina

Boehringer Ingelheim Investigational Site, MAR DEL PLATA, Argentina

Boehringer Ingelheim Investigational Site, Capital Federal, Buenos Aires, Argentina

Boehringer Ingelheim Investigational Site, Capital Federal,Buenos Aires, Argentina

Boehringer Ingelheim Investigational Site, Buenos Aires, Argentina

Boehringer Ingelheim Investigational Site, Bs As, Argentina

Boehringer Ingelheim Investigational Site, San Miguel de Tucuman, Argentina

Boehringer Ingelheim Investigational Site, Mendoza, Argentina

INCOR e Hospital das Clinicas da Universidade de S?o Paulo, S?o Paulo - SP, Brazil

Departamento de Pneumologia, Salvador - BA, Brazil

Depto.de Medicina Interna-Servico de pneumologia, Porto Alegre - RS, Brazil

Lar Escola S?o Francisco, S?o Paulo, Brazil

Faculdade de Medicina Universidade Federal de Juiz de Fora, Juiz de Fora ? MG, Brazil

Boehringer Ingelheim Investigational Site, Porto Alegre - RS, Brazil

Hopital Ambroise Pare, Marseille, France

Boehringer Ingelheim Investigational Site, Nice, France

Clinique de la Louviere, Lille Cedex, France

Boehringer Ingelheim Investigational Site, Nantes, France

Centre hospitalier Germon & Gauthier, Bethune, France

Centre hospitalier Germon & Gauthier, Bethune Cedex, France

Boehringer Ingelheim Investigational Site, Athens, Greece

Boehringer Ingelheim Investigational Site, Larissa, Greece

Boehringer Ingelheim Investigational Site, Thessaloniki, Greece

Boehringer Ingelheim Investigational Site, Kavala, Greece

Boehringer Ingelheim Investigational Site, Mournies-Chania, Greece

Boehringer Ingelheim Investigational Site, Komotini, Greece

Boehringer Ingelheim Investigational Site, Serres, Greece

Boehringer Ingelheim Investigational Site, Heraklion, Greece

Boehringer Ingelheim Investigational Site, Korinthos, Greece

Boehringer Ingelheim Investigational Site, Nafplio, Greece

Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of

Boehringer Ingelheim Investigational Site, Gyeonggi-Do, Korea, Republic of

Boehringer Ingelheim Investigational Site, Daegu, Korea, Republic of

Boehringer Ingelheim Investigational Site, Geonggi-Do, Korea, Republic of

Boehringer Ingelheim Investigational Site, Grafton / Auckland, New Zealand

Private Bag 3200, Hamilton, New Zealand

Boehringer Ingelheim Investigational Site, Dunedin, New Zealand

Boehringer Ingelheim Investigational Site, Wellington, New Zealand

Boehringer Ingelheim Investigational Site, Tauranga, New Zealand

Boehringer Ingelheim Investigational Site, Warsaw, Poland

Boehringer Ingelheim Investigational Site, Proszowice, Poland

Boehringer Ingelheim Investigational Site, Wroclaw, Poland

Boehringer Ingelheim Investigational Site, Ostrow Wielkopolska, Poland

Boehringer Ingelheim Investigational Site, Poznan, Poland

Boehringer Ingelheim Investigational Site, Krakow, Poland

Boehringer Ingelheim Investigational Site, Bydgoszcz, Poland

Boehringer Ingelheim Investigational Site, Radom, Poland

Boehringer Ingelheim Investigational Site, Moscow, Russian Federation

Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation

Boehringer Ingelheim Investigational Site, St.Petersburg, Russian Federation

Boehringer Ingelheim Investigational Site, Kazan, Russian Federation

Boehringer Ingelheim Investigational Site, Cape Town, South Africa

Boehringer Ingelheim Investigational Site, Bellville, South Africa

Boehringer Ingelheim Investigational Site, Paarl, South Africa

Boehringer Ingelheim Investigational Site, Johannesburg, South Africa

Boehringer Ingelheim Investigational Site, Park Town West, South Africa

Boehringer Ingelheim Investigational Site, Boksburg, South Africa

Boehringer Ingelheim Investigational Site, Orange Grove, South Africa

Chang Gung Memorial Hosp-Linkou, Taoyuan, Taiwan

Taipei Veterans General Hospital, Taipei, Taiwan

National Taiwan University Hospital, Taipei, Taiwan

Chang Gong Memorial Hospital, Keelong Town, Taiwan

Taichung Veterans General Hospital, Taichung, Taiwan

Boehringer Ingelheim Investigational Site, Ankara, Turkey

Boehringer Ingelheim Investigational Site, MERSIN, Turkey

Boehringer Ingelheim Investigational Site, Istanbul, Turkey

Boehringer Ingelheim Investigational Site, ISTANBUL, Turkey

Boehringer Ingelheim Investigational Site, ANTALYA, Turkey

Boehringer Ingelheim Investigational Site, Kiev, Ukraine

Boehringer Ingelheim Investigational Site, Dnyepropyetrovsk, Ukraine

Boehringer Ingelheim Investigational Site, Donetsk, Ukraine

Medicine Evaluation Unit, Manchester, United Kingdom

Addenbrooke's Hospital, Cambridge, United Kingdom

Boehringer Ingelheim Investigational Site, Bury St Edmonds, United Kingdom

Morriston Hospital, Swansea, United Kingdom

Colchester General Hospital, Colchester, United Kingdom

Doncaster Royal Infirmary, Doncaster, United Kingdom

Boehringer Ingelheim Investigational Site, Soham, United Kingdom

Boehringer Ingelheim Investigational Site, Ballieston, Glasgow, United Kingdom

Boehringer Ingelheim Investigational Site, Windsor, United Kingdom

Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States

Boehringer Ingelheim Investigational Site, Jasper, Alabama, United States

Boehringer Ingelheim Investigational Site, Mobile, Alabama, United States

Boehringer Ingelheim Investigational Site, Phoenix, Arizona, United States

Boehringer Ingelheim Investigational Site, Lakewood, California, United States

Boehringer Ingelheim Investigational Site, Sepulveda, California, United States

Boehringer Ingelheim Investigational Site, Palo Alto, California, United States

Boehringer Ingelheim Investigational Site, San Jose, California, United States

Boehringer Ingelheim Investigational Site, Torrence, California, United States

Boehringer Ingelheim Investigational Site, Riverside, California, United States

Boehringer Ingelheim Investigational Site, Los Angeles, California, United States

Boehringer Ingelheim Investigational Site, Rancho Mirage, California, United States

Boehringer Ingelheim Investigational Site, Wheat Ridge, Colorado, United States

Boehringer Ingelheim Investigational Site, Fort Collins, Colorado, United States

Boehringer Ingelheim Investigational Site, Denver, Colorado, United States

Boehringer Ingelheim Investigational Site, Stamford, Connecticut, United States

Boehringer Ingelheim Investigational Site, Hartford, Connecticut, United States

Boehringer Ingelheim Investigational Site, Waterbury, Connecticut, United States

Boehringer Ingelheim Investigational Site, Melbourne, Florida, United States

Boehringer Ingelheim Investigational Site, Bay Pines, Florida, United States

Boehringer Ingelheim Investigational Site, Panama City, Florida, United States

Boehringer Ingelheim Investigational Site, Deland, Florida, United States

Boehringer Ingelheim Investigational Site, Clearwater, Florida, United States

Boehringer Ingelheim Investigational Site, Tampa, Florida, United States

Boehringer Ingelheim Investigational Site, Brandon, Florida, United States

Emerald Coast Clinical Research, Pensecola, Florida, United States

Boehringer Ingelheim Investigational Site, Winter Park, Florida, United States

Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States

Boehringer Ingelheim Investigational Site, Decatur, Georgia, United States

Boehringer Ingelheim Investigational Site, Coeur D'Alene, Idaho, United States

Boehringer Ingelheim Investigational Site, Olathe, Kansas, United States

Boehringer Ingelheim Investigational Site, Wichita, Kansas, United States

Boehringer Ingelheim Investigational Site, Bowling Green, Kentucky, United States

Boehringer Ingelheim Investigational Site, New Orleans, Louisiana, United States

Boehringer Ingelheim Investigational Site, Shreveport, Louisiana, United States

Boehringer Ingelheim Investigational Site, Lafayette, Louisiana, United States

Boehringer Ingelheim Investigational Site, Baltimore, Maryland, United States

Boehringer Ingelheim Investigational Site, Ann Arbor, Michigan, United States

Boehringer Ingelheim Investigational Site, Minneapolis, Minnesota, United States

Boehringer Ingelheim Investigational Site, St. Louis, Missouri, United States

Boehringer Ingelheim Investigational Site, Reno, Nevada, United States

Boehringer Ingelheim Investigational Site, Henderson, Nevada, United States

Boehringer Ingelheim Investigational Site, Cherry Hill, New Jersey, United States

Boehringer Ingelheim Investigational Site, Summit, New Jersey, United States

Boehringer Ingelheim Investigational Site, Brick, New Jersey, United States

Boehringer Ingelheim Investigational Site, Albuquerque, New Mexico, United States

Boehringer Ingelheim Investigational Site, New Hyde Park, New York, United States

Boehringer Ingelheim Investigational Site, Larchmont, New York, United States

Boehringer Ingelheim Investigational Site, New York City, New York, United States

Boehringer Ingelheim Investigational Site, Raleigh, North Carolina, United States

Boehringer Ingelheim Investigational Site, Winston-Salem, North Carolina, United States

Boehringer Ingelheim Investigational Site, Asheville, North Carolina, United States

Boehringer Ingelheim Investigational Site, Toledo, Ohio, United States

Boehringer Ingelheim Investigational Site, Sylvania, Ohio, United States

Boehringer Ingelheim Investigational Site, Oklahoma City, Oklahoma, United States

Boehringer Ingelheim Investigational Site, Medford, Oregon, United States

Boehringer Ingelheim Investigational Site, Philadelphia, Pennsylvania, United States

Boehringer Ingelheim Investigational Site, Pittsburgh, Pennsylvania, United States

Boehringer Ingelheim Investigational Site, Hershey, Pennsylvania, United States

Boehringer Ingelheim Investigational Site, Johnston, Rhode Island, United States

Boehringer Ingelheim Investigational Site, East Providence, Rhode Island, United States

Boehringer Ingelheim Investigational Site, Spartanburg, South Carolina, United States

Boehringer Ingelheim Investigational Site, Charleston, South Carolina, United States

Boehringer Ingelheim Investigational Site, Greenville, South Carolina, United States

Boehringer Ingelheim Investigational Site, Greer, South Carolina, United States

Boehringer Ingelheim Investigational Site, Nashville, Tennessee, United States

Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States

Boehringer Ingelheim Investigational Site, Houston, Texas, United States

Boehringer Ingelheim Investigational Site, Killeen, Texas, United States

Boehringer Ingelheim Investigational Site, Fort Worth, Texas, United States

Boehringer Ingelheim Investigational Site, Richmond, Virginia, United States

Boehringer Ingelheim Investigational Site, Roanoke, Virginia, United States

Boehringer Ingelheim Investigational Site, Salem, Virginia, United States

Boehringer Ingelheim Investigational Site, Spokane, Washington, United States

Boehringer Ingelheim Investigational Site, Tacoma, Washington, United States

Boehringer Ingelheim Investigational Site, Bellington, Washington, United States

Boehringer Ingelheim Investigational Site, Morgantown, West Virginia, United States

Ending date: July 2008
Last updated: May 15, 2008