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 September 03, 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
Jasper, Alabama, United States
Mobile, Alabama, United States
Boulder, Colorado, United States
Wheat Ridge, Colorado, United States
Stamford, Connecticut, United States
Clearwater, Florida, United States
Clearwater, Florida, United States
Panama City, Florida, United States
O'fallon, Illinois, United States
Opelousas, Louisiana, United States
Shreveport, Louisiana, United States
Biddeford, Maine, United States
Columbia, Maryland, United States
Livonia, Michigan, United States
Omaha, Nebraska, United States
Larchmont, New York, United States
Rochester, New York, United States
Raleigh, North Carolina, United States
Tabor City, North Carolina, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Charleston, Pennsylvania, United States
Johnston, Rhode Island, United States
Easley, South Carolina, United States
Gaffney, South Carolina, United States
Spartanburg, South Carolina, United States
Ft. Worth, Texas, United States
San Antonio, Texas, United States
Lynchburg, Virginia, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Morgantown, West Virginia, United States
Buenos Aires, , Argentina
Caba, , Argentina
Caba, , Argentina
Capital Federal, , Argentina
Cuidad Autonoma De Buenos Airess A, , Argentina
Mar Del Plata, , Argentina
Mar Del Plata, , Argentina
Mendoza, , Argentina
Monte Grande, , Argentina
Quilmes, , Argentina
Rosario, , Argentina
San Miguel De Tucuman, , Argentina
San Miguel De Tucuma, , Argentina
Toorak Gardens, South Australia, Australia
Woodville, South Australia, Australia
Frankston, Victoria, Australia
Plovdiv, , Bulgaria
Rousse, , Bulgaria
Shumen, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Troyan, , Bulgaria
Veliko Tarnovo, , Bulgaria
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Burlington, Ontario, Canada
Grimsby, Ontario, Canada
Ottawa, Ontario, Canada
Sherbrooke, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Quebec, , Canada
Quebec, , Canada
Beijing, , China
Beijing, , China
Changsha, , China
Changsha, , China
Foshan, , China
Guangzhou, , China
Nan Ning, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shenyang, , China
Wuhan, , China
Xi'an, , China
Yangzhou, , China
Yinchuan, , China
Beroun, , Czech Republic
Cvikov, , Czech Republic
Praha 6, , Czech Republic
Rokycany, , Czech Republic
Znojmo, , Czech Republic
Aalborg, , Denmark
Hvidovre, , Denmark
Kolding, , Denmark
København Nv, , Denmark
Næstved, , Denmark
Odense C, , Denmark
Roskilde, , Denmark
Silkeborg, , Denmark
Sønderborg, , Denmark
Vaerløse, , Denmark
Tallin, , Estonia
Tartu, , Estonia
Helsinki, , Finland
Pori, , Finland
Turku, , Finland
Bethune Cedex, , France
Montpellier Cedex 5, , France
Nantes, , France
Nîmes Cedex 9, , France
Perpignan, , France
Saint Pierre Cedex, , France
Strasbourg, , France
Bamberg, , Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Erfurt, , Germany
Hamburg, , Germany
Hamburg, , Germany
Koblenz, , Germany
Neu Isenburg, , Germany
Oschersleben, , Germany
Rüdersdorf, , Germany
Weinheim, , Germany
Wiesloch, , Germany
Guatemala, , Guatemala
Guatemala, , Guatemala
Guatemala, , Guatemala
Guatemala, , Guatemala
Guatemala, , Guatemala
Guatemala, , Guatemala
Guatemala, , Guatemala
Debrecen, , Hungary
Deszk, , Hungary
Kapuvar, , Hungary
Szombathely, , Hungary
Törökbalint, , Hungary
Ahmedabad, , India
Bangalore, , India
Bangalore, , India
Coimbatore, , India
Hyderabad, , India
Jaipur, , India
Jaipur, , India
Mysore, , India
Pune, , India
Cagliari, , Italy
Genova, , Italy
Montescano (Pv), , Italy
Monza, , Italy
Parma, , Italy
Pisa, , Italy
Aoba Ku, Sendai, Miyagi, , Japan
Asahikawa, Hokkaido, , Japan
Bunkyo Ku, Tokyo, , Japan
Chuo Ku, Kumamoto, Kumamoto, , Japan
Gifu, Gifu, , Japan
Hakata Ku, Fukuoka, Fukuoka, , Japan
Hamamatsushi, Shizuoka, , Japan
Himeji, Hyogo, , Japan
Ikoma, Nara, , Japan
Inashiki Gun, Ibaraki, , Japan
Itabashi Ku, Tokyo, , Japan
Jonan Ku, Fukuoka, Fukuoka, , Japan
Kagoshima, Kagoshima,, , Japan
Kagoshima, Kagoshima, , Japan
Kamogawa, Chiba, , Japan
Kishiwada, Osaka, , Japan
Kitakyusyu,Fukuoka, , Japan
Koga, Fukuoka, , Japan
Komaki, Aichi, , Japan
Komaki, Aichi, , Japan
Koshi, Kumamoto, , Japan
Koto Ku, Tokyo, , Japan
Kuki, Saitama, , Japan
Kure, Hiroshima, , Japan
Kurume, Fukuoka, , Japan
Matsumoto, Nagano, , Japan
Matsumoto, Nagano, , Japan
Matsusaka, Mie, , Japan
Minami Ku. Fukuoka, Fukuoka, , Japan
Morioka, Iwate, , Japan
Nagoya, Aichi, , Japan
Nagoya, Aichi, , Japan
Naka Gun, Ibaraki, , Japan
Okinawa, Urasoe, , Japan
Okinawa, Urasoe, , Japan
Sayama, Osaka, , Japan
Sendai, Miyagi, , Japan
Seto, Aichi, , Japan
Shinagawa, Tokyo, , Japan
Shinjyuku Ku, Tokyo, , Japan
Takamatsu, Kagawa, , Japan
Takamatsu, Kagawa, , Japan
Wakayama, Wakayama, , Japan
Yanagawa Shi, Fukuoka,, , Japan
Yokohama, Kanagawa, , Japan
Bucheon, , Korea, Republic Of
Daegu, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Suwon, , Korea, Republic Of
Wonju, , Korea, Republic Of
Hermosillo, , Mexico
Mexico, , Mexico
Monterrey, , Mexico
Tijuana, , Mexico
Almelo, , Netherlands
Breda, , Netherlands
Eindhoven, , Netherlands
Harderwijk, , Netherlands
Heerlen, , Netherlands
Hengelo, , Netherlands
Hoorn, , Netherlands
Nieuwegein, , Netherlands
Veldhoven, , Netherlands
Zutphen, , Netherlands
Dunedin, , New Zealand
Greenlane East Auckland Nz, , New Zealand
Amadora, , Portugal
Coimbra, , Portugal
Lisboa, , Portugal
Lisboa, , Portugal
Porto, , Portugal
Vila Nova De Gaia, , Portugal
Viseu, , Portugal
Gatchina (Leningradskaya Oblast), , Russian Federation
Kazan, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
St. Petersburg, , Russian Federation
Golnik, , Slovenia
Golnik, , Slovenia
Istanbul, , Turkey
Istanbul, , Turkey
Izmir, , Turkey
Izmit, , Turkey
Mersin, , Turkey
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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