Tiotropium +Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)
Launched by BOEHRINGER INGELHEIM · Sep 8, 2011
Trial Information
Current as of July 25, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • 1. Diagnosis of chronic obstructive pulmonary disease.
- • 2. Relatively stable airway obstruction with post FEV1\< 80% predicted normal and post FEV1/FVC \<70%.
- • 3. Male or female patients, 40 years of age or older.
- • 4. Smoking history of more than 10 pack years.
- Exclusion criteria:
- • 1. Significant disease other than COPD
- • 2. Clinically relevant abnormal lab values.
- • 3. History of asthma.
- • 4. Diagnosis of thyrotoxicosis
- • 5. Diagnosis of paroxysmal tachycardia
- • 6. History of myocardial infarction within 1 year of screening visit
- • 7. Unstable or life-threatening cardiac arrhythmia.
- • 8. Hospitalization for heart failure within the past year.
- • 9. Known active tuberculosis.
- • 10. Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
- • 11. History of life-threatening pulmonary obstruction.
- • 12. History of cystic fibrosis.
- • 13. Clinically evident bronchiectasis.
- • 14. History of significant alcohol or drug abuse.
- • 15. Thoracotomy with pulmonary resection
- • 16. Oral ß-adrenergics.
- • 17. Oral corticosteroid medication at unstable doses
- • 18. Regular use of daytime oxygen therapy for more than one hour per day
- • 19. Pulmonary rehabilitation program in the six weeks prior to the screening visit
- • 20. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
- • 21. Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA
- • 22. Pregnant or nursing women.
- • 23. Women of childbearing potential not using a highly effective method of birth control
- • 24. Patients who are unable to comply with pulmonary medication restrictions
About Boehringer Ingelheim
Boehringer Ingelheim is a global, research-driven pharmaceutical company dedicated to improving health and quality of life through innovative therapies. Established in 1885 and headquartered in Ingelheim, Germany, the company focuses on the development of prescription medicines in key therapeutic areas, including respiratory diseases, cardiovascular health, oncology, and immunology. Boehringer Ingelheim is committed to advancing medical science through rigorous clinical trials and collaborative research, striving to bring novel treatments to patients while upholding the highest standards of safety and efficacy. With a strong emphasis on sustainability and corporate responsibility, the company aims to make a meaningful impact on global health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Greer, California, United States
Fort Collins, Colorado, United States
Danbury, Connecticut, United States
Waterbury, Connecticut, United States
Deland, Florida, United States
Tampa, Florida, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Couer D'alene, Idaho, United States
Lafayette, Louisiana, United States
Baltimore, Maryland, United States
North Dartmouth, Massachusetts, United States
Minneapolis, Minnesota, United States
Plymouth, Minnesota, United States
St. Louis, Missouri, United States
St. Louis, Missouri, United States
Henderson, Nevada, United States
Marlton, New Jersey, United States
Albuquerque, New Mexico, United States
Bayside, New York, United States
Great Neck, New York, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
East Providence, Rhode Island, United States
Charleston, South Carolina, United States
Greenville, South Carolina, United States
Greenville, South Carolina, United States
Spartanburg, South Carolina, United States
Union, South Carolina, United States
Killeen, Texas, United States
Mckinney, Texas, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Feldbach, , Austria
Gänserndorf, , Austria
Innsbruck, , Austria
Leoben, , Austria
Linz, , Austria
Salzburg, , Austria
Brussel, , Belgium
Bruxelles, , Belgium
Gent, , Belgium
Jambes, , Belgium
Lebbeke, , Belgium
Leuven, , Belgium
Liège, , Belgium
Oostende, , Belgium
Turnhout, , Belgium
Botucatu, , Brazil
Florianopolis, , Brazil
Passo Fundo, , Brazil
Porto Alegre, , Brazil
Porto Alegre, , Brazil
Porto Alegre, , Brazil
Porto Alegre, , Brazil
Porto Alegre, , Brazil
Sao Paulo, , Brazil
Sao Paulo, , Brazil
Sao Paulo, , Brazil
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Moncton, New Brunswick, Canada
Courtice, Ontario, Canada
Downsview, Ontario, Canada
Sarnia, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Point Claire, Quebec, Canada
Sherbrooke, Quebec, Canada
Ste Foy, Quebec, Canada
Baotou, , China
Beijing, , China
Beijing, , China
Beijing, , China
Changsha, , China
Chengdu, , China
Chongqing, , China
Haikou, , China
Hangzhou, , China
Hohhot, , China
Jinan, , China
Nanjing, , China
Shanghai, , China
Shenyang, , China
Suzhou, , China
Xi'an, , China
Bogota Dc, , Colombia
Bogota Dc, , Colombia
Bogota Dc, , Colombia
Bogota, , Colombia
Cali, , Colombia
Floridablanca, , Colombia
Petrinja, , Croatia
Rijeka, , Croatia
Zadar, , Croatia
Zagreb, , Croatia
Aschaffenburg, , Germany
Berlin, , Germany
Frankfurt, , Germany
Frankfurt, , Germany
Großhansdorf, , Germany
Halle, , Germany
Hamburg, , Germany
Hannover, , Germany
Leipzig, , Germany
Mainz, , Germany
Rodgau/Dudenhofen, , Germany
Schwerin, , Germany
Teuchern, , Germany
Debrecen, , Hungary
Gödöllö, , Hungary
Pecs, , Hungary
Sopron, , Hungary
Szeged, , Hungary
Chennai, , India
Coimbatore, , India
Jaipur, , India
Kolkatta, , India
Maharastra, , India
Mumbai, , India
Nashik, Maharashtra, , India
Pune, , India
County Limerick, , Ireland
Dublin 24, , Ireland
Dublin 4, , Ireland
Abeno Ku, Osaka, Osaka, , Japan
Aoi Ku, Shizuoka, Shizuoka, , Japan
Chuo Ku, Kobe, Hyogo, , Japan
Fukui, Fukui, , Japan
Fukuyama, Hiroshima, , Japan
Hachioji, Tokyo, , Japan
Himeji, Hyogo, , Japan
Hitachi, Ibaraki, , Japan
Iizuka, Fukuoka, , Japan
Iwamizawa, Hokkaido, , Japan
Kamakura, Kanagawa, , Japan
Kanazawa, Ishikawa, , Japan
Kanazawa, Yokohama, Kanagawa, , Japan
Kashiwa, Chiba, , Japan
Kawasaki Ku, Kawasaki, Kanagawa, , Japan
Kita Ku, Okayama, Okayama, , Japan
Kita Ku, Sakai, Osaka, , Japan
Kita Ku, Sapporo, Hokkaido, , Japan
Kurashiki, Okayama, , Japan
Minami Ku, Yokohama, Kanagawa, , Japan
Minami Ku, Yokohama, Kanagawa, , Japan
Mitaka, Tokyo, , Japan
Mito, Ibaraki, , Japan
Naha, Okinawa, , Japan
Nishi Ku, Kobe, Hyogo, , Japan
Obihiro, Hokkaido, , Japan
Okinawa, Okinawa, , Japan
Ota Ku, Tokyo, , Japan
Sakaide, Kagawa, , Japan
Sapporo, Hokkaido, , Japan
Shimajiri Gun, Okinawa, , Japan
Shimajiri Gun, Okinawa, , Japan
Shinjuku Ku, Tokyo, , Japan
Shinjuku Ku, Tokyo, , Japan
Soka, Saitama, , Japan
Takarazuka, Hyogo, , Japan
Takayama, Gifu, , Japan
Tomigusuku, Okinawa, , Japan
Toyonaka, Osaka, , Japan
Uji, Kyoto, , Japan
Yabu, Hyogo, , Japan
Yao, Osaka, , Japan
Yokosuka, Kanagawa, , Japan
Elverum, , Norway
Hønefoss, , Norway
Kløfta, , Norway
Lierskogen, , Norway
Oslo, , Norway
Ski, , Norway
Svelvik, , Norway
Arad, , Romania
Arad, , Romania
Bucharest, , Romania
Bucuresti, , Romania
Cluj, , Romania
Moscow, , Russian Federation
Moscow, , Russian Federation
St. Petersburg, , Russian Federation
St. Petersburg, , Russian Federation
Yaroslavl, , Russian Federation
Belgrade, , Serbia
Belgrade, , Serbia
Belgrade, , Serbia
Kragujevac, , Serbia
Nis, , Serbia
Bardejov, , Slovakia
Bojnice, , Slovakia
Kosice, , Slovakia
Nitra, , Slovakia
Spisska Nova Ves, , Slovakia
Zilina, , Slovakia
Bellville, , South Africa
Cape Town, , South Africa
Cape Town, , South Africa
Cape Town, , South Africa
Pretoria, , South Africa
Badalona (Barcelona), , Spain
Barcelona, , Spain
Barcelona, , Spain
Hospitalet De Llobregat, , Spain
Mérida, , Spain
Pozuelo De Alarcón, , Spain
San Juan De Alicante, , Spain
Vic (Barcelona), , Spain
Boden, , Sweden
Göteborg, , Sweden
Härnösand, , Sweden
Höllviken, , Sweden
Lund, , Sweden
Stockholm, , Sweden
Uddevalla, , Sweden
Kaohsiung City, , Taiwan
Kaohsiung, , Taiwan
New Taipei City, , Taiwan
Taichung, , Taiwan
Tainan, , Taiwan
Taipei, , Taiwan
Taoyuan County, , Taiwan
Ankara, , Turkey
Denizli, , Turkey
Istanbul, , Turkey
Izmir, , Turkey
Izmir, , Turkey
Blackpool, , United Kingdom
Blackpool, , United Kingdom
Bristol, , United Kingdom
Chertsey, , United Kingdom
Fleetwood, , United Kingdom
Manchester, , United Kingdom
Midsomer Norton, , United Kingdom
Patients applied
Trial Officials
Boehringer Ingelheim
Study Chair
Boehringer Ingelheim
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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