Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
---|---|
Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00793624 |
The primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat® inhaler, in patients with COPD.
Condition | Intervention | Phase |
---|---|---|
Pulmonary Disease, Chronic Obstructive |
Drug: BI 1744 CL Drug: Formoterol |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised, Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group Efficacy and Safety Comparison of One-Year Treatment of Two Doses (5mcg (2 Actuations of 2.5 Mcg) and 10mcg (2 Actuations of 5mcg)) of BI 1744 CL Inhalation Solution Delivered by the Respimat® Inhaler, and One Dose (12mcg) of Foradil® Delivered by the Aerolizer® Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD). |
Estimated Enrollment: | 860 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Boehringer Ingelheim Study Coordinator | 800-542-6257 ext Option 4 | clintriage.rdg@boehringer-ingelheim.com |
Canada, Alberta | |
1222.13.1408 Boehringer Ingelheim Investigational Site | |
Calgary, Alberta, Canada | |
1222.13.1409 Boehringer Ingelheim Investigational Site | |
Edmonton, Alberta, Canada | |
Canada, British Columbia | |
1222.13.1407 Boehringer Ingelheim Investigational Site | |
Chilliwack, British Columbia, Canada | |
Canada, Ontario | |
1222.13.1413 Boehringer Ingelheim Investigational Site | |
Toronto, Ontario, Canada | |
1222.13.1401 Boehringer Ingelheim Investigational Site | |
Niagara Falls, Ontario, Canada | |
1222.13.1403 Boehringer Ingelheim Investigational Site | |
Downsview, Ontario, Canada | |
1222.13.1410 Boehringer Ingelheim Investigational Site | |
Sarnia, Ontario, Canada | |
1222.13.1412 Boehringer Ingelheim Investigational Site | |
Hamilton, Ontario, Canada | |
Canada, Quebec | |
1222.13.1404 Boehringer Ingelheim Investigational Site | |
La Malbaie, Quebec, Canada | |
1222.13.1406 Boehringer Ingelheim Investigational Site | |
Point Claire, Quebec, Canada | |
1222.13.1411 Boehringer Ingelheim Investigational Site | |
Montreal, Quebec, Canada | |
Canada, Saskatchewan | |
1222.13.1402 Boehringer Ingelheim Investigational Site | |
Saskatoon, Saskatchewan, Canada | |
Denmark | |
1222.13.2001 Boehringer Ingelheim Investigational Site | |
Silkeborg, Denmark | |
1222.13.2002 Boehringer Ingelheim Investigational Site | |
Hvidovre, Denmark | |
1222.13.2003 Boehringer Ingelheim Investigational Site | |
Aalborg, Denmark | |
Finland | |
1222.13.2101 Boehringer Ingelheim Investigational Site | |
Tampere, Finland | |
1222.13.2102 Boehringer Ingelheim Investigational Site | |
Turku, Finland | |
1222.13.2103 Boehringer Ingelheim Investigational Site | |
Lahti, Finland |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1222.13, Eudract: 2008-001933-84 |
Study First Received: | November 18, 2008 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00793624 |
Health Authority: | Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica); Brazil: National Health Surveillance Agency; Canada: Therapeutic Products Directorate; Croatia: Croatian Institute for Medicines Control, HR-10000 Zagreb; Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10; Denmark: The Danish Medicines Agency; Finland: National Agency for Medicines; Germany: Federal Institute for Drugs and Medical Devices; Hong Kong: Department of Health; India: Ministry of Health and Family Welfare; Italy: Comitato Etico per la sperim. clinica dei medicinali dell'A.O. Universitaria Pisana di Pisa; Korea, Republic of: Korea Food and Drug Administration; Malaysia: Ministry of Health; Norway: Norwegian Medicines Agency (Statens Legemiddelverk); Philippines: Department of Health; South Africa: Medicines Control Council; Spain: Agencia Espanola del Medicamento y Productos Sanitarios; Sweden: Medical Products Agency Regional Ethics Committee of Umeå; Thailand: Ministry of Public Health; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine) |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders |
Formoterol Chronic Disease Pulmonary Disease, Chronic Obstructive |
Respiratory System Agents Disease Attributes Neurotransmitter Agents Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents |
Adrenergic Agonists Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |