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Tiotropium +Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT01431287

Last Updated: 2015-07-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2539 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-11-30

Brief Summary

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The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components (tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with COPD.

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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tiotropium+olodaterol high dose FDC

Once daily 2 puffs solution for inhalation Respimat

Group Type EXPERIMENTAL

tiotropium + olodaterol

Intervention Type DRUG

fixed dose combination

Respimat

Intervention Type DEVICE

Respimat inhaler

tiotropium+olodaterol low dose FDC

Once daily 2 puffs solution for inhalation Respimat

Group Type EXPERIMENTAL

tiotropium + olodaterol

Intervention Type DRUG

fixed dose combination

Respimat

Intervention Type DEVICE

Respimat inhaler

olodaterol

Once daily 2 puffs solution for inhalation Respimat

Group Type ACTIVE_COMPARATOR

olodaterol

Intervention Type DRUG

one dose only

Respimat

Intervention Type DEVICE

Respimat inhaler

tiotropium low dose

Once daily 2 puffs solution for inhalation Respimat

Group Type ACTIVE_COMPARATOR

tiotropium

Intervention Type DRUG

low dose or high dose

Respimat

Intervention Type DEVICE

Respimat inhaler

tiotropium high dose

Once daily 2 puffs solution for inhalation Respimat

Group Type ACTIVE_COMPARATOR

tiotropium

Intervention Type DRUG

low dose or high dose

Respimat

Intervention Type DEVICE

Respimat inhaler

Interventions

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tiotropium + olodaterol

fixed dose combination

Intervention Type DRUG

tiotropium + olodaterol

fixed dose combination

Intervention Type DRUG

tiotropium

low dose or high dose

Intervention Type DRUG

tiotropium

low dose or high dose

Intervention Type DRUG

olodaterol

one dose only

Intervention Type DRUG

Respimat

Respimat inhaler

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1237.6.01106 Boehringer Ingelheim Investigational Site

Greer, California, United States

Site Status

1237.6.01120 Boehringer Ingelheim Investigational Site

Fort Collins, Colorado, United States

Site Status

1237.6.01131 Boehringer Ingelheim Investigational Site

Danbury, Connecticut, United States

Site Status

1237.6.01117 Boehringer Ingelheim Investigational Site

Waterbury, Connecticut, United States

Site Status

1237.6.01118 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Site Status

1237.6.01126 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Site Status

1237.6.01109 Boehringer Ingelheim Investigational Site

Winter Park, Florida, United States

Site Status

1237.6.01134 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Site Status

1237.6.01107 Boehringer Ingelheim Investigational Site

Couer d'Alene, Idaho, United States

Site Status

1237.6.01110 Boehringer Ingelheim Investigational Site

Lafayette, Louisiana, United States

Site Status

1237.6.01128 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Site Status

1237.6.01130 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Site Status

1237.6.01104 Boehringer Ingelheim Investigational Site

Minneapolis, Minnesota, United States

Site Status

1237.6.01116 Boehringer Ingelheim Investigational Site

Plymouth, Minnesota, United States

Site Status

1237.6.01121 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Site Status

1237.6.01123 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Site Status

1237.6.01129 Boehringer Ingelheim Investigational Site

Henderson, Nevada, United States

Site Status

1237.6.01136 Boehringer Ingelheim Investigational Site

Marlton, New Jersey, United States

Site Status

1237.6.01108 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Site Status

1237.6.01127 Boehringer Ingelheim Investigational Site

Bayside, New York, United States

Site Status

1237.6.01139 Boehringer Ingelheim Investigational Site

Great Neck, New York, United States

Site Status

1237.6.01135 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Site Status

1237.6.01114 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Site Status

1237.6.01102 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Site Status

1237.6.01115 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

1237.6.01101 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

1237.6.01113 Boehringer Ingelheim Investigational Site

East Providence, Rhode Island, United States

Site Status

1237.6.01122 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Site Status

1237.6.01132 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Site Status

1237.6.01137 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Site Status

1237.6.01111 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Site Status

1237.6.01105 Boehringer Ingelheim Investigational Site

Union, South Carolina, United States

Site Status

1237.6.01138 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

Site Status

1237.6.01124 Boehringer Ingelheim Investigational Site

McKinney, Texas, United States

Site Status

1237.6.01112 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

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1237.6.01133 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

1237.6.01125 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Site Status

1237.6.01103 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

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1237.6.43006 Boehringer Ingelheim Investigational Site

Feldbach, , Austria

Site Status

1237.6.43005 Boehringer Ingelheim Investigational Site

Gänserndorf, , Austria

Site Status

1237.6.43002 Boehringer Ingelheim Investigational Site

Innsbruck, , Austria

Site Status

1237.6.43004 Boehringer Ingelheim Investigational Site

Leoben, , Austria

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1237.6.43001 Boehringer Ingelheim Investigational Site

Linz, , Austria

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1237.6.43003 Boehringer Ingelheim Investigational Site

Salzburg, , Austria

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1237.6.32005 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1237.6.32007 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

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1237.6.32004 Boehringer Ingelheim Investigational Site

Ghent, , Belgium

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1237.6.32002 Boehringer Ingelheim Investigational Site

Jambes, , Belgium

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1237.6.32009 Boehringer Ingelheim Investigational Site

Lebbeke, , Belgium

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1237.6.32001 Boehringer Ingelheim Investigational Site

Leuven, , Belgium

Site Status

1237.6.32006 Boehringer Ingelheim Investigational Site

Liège, , Belgium

Site Status

1237.6.32008 Boehringer Ingelheim Investigational Site

Ostend, , Belgium

Site Status

1237.6.32010 Boehringer Ingelheim Investigational Site

Turnhout, , Belgium

Site Status

1237.6.55013 Boehringer Ingelheim Investigational Site

Botucatu, , Brazil

Site Status

1237.6.55010 Boehringer Ingelheim Investigational Site

Florianópolis, , Brazil

Site Status

1237.6.55012 Boehringer Ingelheim Investigational Site

Passo Fundo, , Brazil

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1237.6.55001 Boehringer Ingelheim Investigational Site

Porto Alegre, , Brazil

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1237.6.55002 Boehringer Ingelheim Investigational Site

Porto Alegre, , Brazil

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1237.6.55003 Boehringer Ingelheim Investigational Site

Porto Alegre, , Brazil

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1237.6.55005 Boehringer Ingelheim Investigational Site

Porto Alegre, , Brazil

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1237.6.55009 Boehringer Ingelheim Investigational Site

Porto Alegre, , Brazil

Site Status

1237.6.55006 Boehringer Ingelheim Investigational Site

São Paulo, , Brazil

Site Status

1237.6.55007 Boehringer Ingelheim Investigational Site

São Paulo, , Brazil

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1237.6.55011 Boehringer Ingelheim Investigational Site

São Paulo, , Brazil

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1237.6.02109 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Site Status

1237.6.02111 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1237.6.02106 Boehringer Ingelheim Investigational Site

Moncton, New Brunswick, Canada

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1237.6.02110 Boehringer Ingelheim Investigational Site

Courtice, Ontario, Canada

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1237.6.02101 Boehringer Ingelheim Investigational Site

Downsview, Ontario, Canada

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1237.6.02112 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Site Status

1237.6.02103 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1237.6.02102 Boehringer Ingelheim Investigational Site

Windsor, Ontario, Canada

Site Status

1237.6.02104 Boehringer Ingelheim Investigational Site

Point Claire, Quebec, Canada

Site Status

1237.6.02105 Boehringer Ingelheim Investigational Site

Sherbrooke, Quebec, Canada

Site Status

1237.6.02108 Boehringer Ingelheim Investigational Site

Ste-Foy, Quebec, Canada

Site Status

1237.6.86117 Boehringer Ingelheim Investigational Site

Baotou, , China

Site Status

1237.6.86102 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1237.6.86104 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1237.6.86105 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1237.6.86115 Boehringer Ingelheim Investigational Site

Changsha, , China

Site Status

1237.6.86110 Boehringer Ingelheim Investigational Site

Chengdu, , China

Site Status

1237.6.86111 Boehringer Ingelheim Investigational Site

Chongqing, , China

Site Status

1237.6.86109 Boehringer Ingelheim Investigational Site

Haikou, , China

Site Status

1237.6.86108 Boehringer Ingelheim Investigational Site

Hangzhou, , China

Site Status

1237.6.86116 Boehringer Ingelheim Investigational Site

Hohhot, , China

Site Status

1237.6.86114 Boehringer Ingelheim Investigational Site

Jinan, , China

Site Status

1237.6.86106 Boehringer Ingelheim Investigational Site

Nanjing, , China

Site Status

1237.6.86101 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1237.6.86113 Boehringer Ingelheim Investigational Site

Shenyang, , China

Site Status

1237.6.86107 Boehringer Ingelheim Investigational Site

Suzhou, , China

Site Status

1237.6.86112 Boehringer Ingelheim Investigational Site

Xi'an, , China

Site Status

1237.6.57001 Boehringer Ingelheim Investigational Site

Bogota DC, , Colombia

Site Status

1237.6.57003 Boehringer Ingelheim Investigational Site

Bogota DC, , Colombia

Site Status

1237.6.57007 Boehringer Ingelheim Investigational Site

Bogota DC, , Colombia

Site Status

1237.6.57008 Boehringer Ingelheim Investigational Site

Bogotá, , Colombia

Site Status

1237.6.57006 Boehringer Ingelheim Investigational Site

Cali, , Colombia

Site Status

1237.6.57004 Boehringer Ingelheim Investigational Site

Floridablanca, , Colombia

Site Status

1237.6.38503 Boehringer Ingelheim Investigational Site

Petrinja, , Croatia

Site Status

1237.6.38504 Boehringer Ingelheim Investigational Site

Rijeka, , Croatia

Site Status

1237.6.38502 Boehringer Ingelheim Investigational Site

Zadar, , Croatia

Site Status

1237.6.38501 Boehringer Ingelheim Investigational Site

Zagreb, , Croatia

Site Status

1237.6.49022 Boehringer Ingelheim Investigational Site

Aschaffenburg, , Germany

Site Status

1237.6.49017 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1237.6.49026 Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

Site Status

1237.6.49027 Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

Site Status

1237.6.49025 Boehringer Ingelheim Investigational Site

Großhansdorf, , Germany

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1237.6.49016 Boehringer Ingelheim Investigational Site

Halle, , Germany

Site Status

1237.6.49024 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1237.6.49021 Boehringer Ingelheim Investigational Site

Hanover, , Germany

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1237.6.49019 Boehringer Ingelheim Investigational Site

Leipzig, , Germany

Site Status

1237.6.49028 Boehringer Ingelheim Investigational Site

Mainz, , Germany

Site Status

1237.6.49018 Boehringer Ingelheim Investigational Site

Rodgau/Dudenhofen, , Germany

Site Status

1237.6.49020 Boehringer Ingelheim Investigational Site

Schwerin, , Germany

Site Status

1237.6.49023 Boehringer Ingelheim Investigational Site

Teuchern, , Germany

Site Status

1237.6.36001 Boehringer Ingelheim Investigational Site

Debrecen, , Hungary

Site Status

1237.6.36004 Boehringer Ingelheim Investigational Site

Gödöllö, , Hungary

Site Status

1237.6.36005 Boehringer Ingelheim Investigational Site

Pécs, , Hungary

Site Status

1237.6.36003 Boehringer Ingelheim Investigational Site

Sopron, , Hungary

Site Status

1237.6.36002 Boehringer Ingelheim Investigational Site

Szeged, , Hungary

Site Status

1237.6.91003 Boehringer Ingelheim Investigational Site

Chennai, , India

Site Status

1237.6.91011 Boehringer Ingelheim Investigational Site

Coimbatore, , India

Site Status

1237.6.91004 Boehringer Ingelheim Investigational Site

Jaipur, , India

Site Status

1237.6.91002 Boehringer Ingelheim Investigational Site

Kolkata, , India

Site Status

1237.6.91007 Boehringer Ingelheim Investigational Site

Maharastra, , India

Site Status

1237.6.91006 Boehringer Ingelheim Investigational Site

Mumbai, , India

Site Status

1237.6.91009 Boehringer Ingelheim Investigational Site

Nashik, Maharashtra, , India

Site Status

1237.6.91008 Boehringer Ingelheim Investigational Site

Pune, , India

Site Status

1237.6.35304 Boehringer Ingelheim Investigational Site

County Limerick, , Ireland

Site Status

1237.6.35301 Boehringer Ingelheim Investigational Site

Dublin, , Ireland

Site Status

1237.6.35303 Boehringer Ingelheim Investigational Site

Dublin, , Ireland

Site Status

1237.6.81127 Boehringer Ingelheim Investigational Site

Abeno-ku, Osaka, Osaka, , Japan

Site Status

1237.6.81123 Boehringer Ingelheim Investigational Site

Aoi-ku, Shizuoka, Shizuoka, , Japan

Site Status

1237.6.81132 Boehringer Ingelheim Investigational Site

Chuo-ku, Kobe, Hyogo, , Japan

Site Status

1237.6.81121 Boehringer Ingelheim Investigational Site

Fukui, Fukui, , Japan

Site Status

1237.6.81137 Boehringer Ingelheim Investigational Site

Fukuyama, Hiroshima, , Japan

Site Status

1237.6.81109 Boehringer Ingelheim Investigational Site

Hachioji, Tokyo, , Japan

Site Status

1237.6.81134 Boehringer Ingelheim Investigational Site

Himeji, Hyogo, , Japan

Site Status

1237.6.81106 Boehringer Ingelheim Investigational Site

Hitachi, Ibaraki, , Japan

Site Status

1237.6.81139 Boehringer Ingelheim Investigational Site

Iizuka, Fukuoka, , Japan

Site Status

1237.6.81102 Boehringer Ingelheim Investigational Site

Iwamizawa, Hokkaido, , Japan

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1237.6.81117 Boehringer Ingelheim Investigational Site

Kamakura, Kanagawa, , Japan

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1237.6.81120 Boehringer Ingelheim Investigational Site

Kanazawa, Ishikawa, , Japan

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1237.6.81113 Boehringer Ingelheim Investigational Site

Kanazawa, Yokohama, Kanagawa, , Japan

Site Status

1237.6.81108 Boehringer Ingelheim Investigational Site

Kashiwa, Chiba, , Japan

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1237.6.81114 Boehringer Ingelheim Investigational Site

Kawasaki-ku, Kawasaki, Kanagawa, , Japan

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1237.6.81135 Boehringer Ingelheim Investigational Site

Kita-ku, Okayama, Okayama, , Japan

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1237.6.81126 Boehringer Ingelheim Investigational Site

Kita-ku, Sakai, Osaka, , Japan

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1237.6.81101 Boehringer Ingelheim Investigational Site

Kita-ku, Sapporo, Hokkaido, , Japan

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1237.6.81136 Boehringer Ingelheim Investigational Site

Kurashiki, Okayama, , Japan

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1237.6.81116 Boehringer Ingelheim Investigational Site

Minami-ku, Yokohama, Kanagawa, , Japan

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1237.6.81118 Boehringer Ingelheim Investigational Site

Minami-ku, Yokohama, Kanagawa, , Japan

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1237.6.81112 Boehringer Ingelheim Investigational Site

Mitaka, Tokyo, , Japan

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1237.6.81105 Boehringer Ingelheim Investigational Site

Mito, Ibaraki, , Japan

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1237.6.81142 Boehringer Ingelheim Investigational Site

Naha, Okinawa, , Japan

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1237.6.81131 Boehringer Ingelheim Investigational Site

Nishi-ku, Kobe, Hyogo, , Japan

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1237.6.81104 Boehringer Ingelheim Investigational Site

Obihiro, Hokkaido, , Japan

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1237.6.81141 Boehringer Ingelheim Investigational Site

Okinawa, Okinawa, , Japan

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1237.6.81110 Boehringer Ingelheim Investigational Site

Ota-ku, Tokyo, , Japan

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1237.6.81138 Boehringer Ingelheim Investigational Site

Sakaide, Kagawa, , Japan

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1237.6.81103 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

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1237.6.81140 Boehringer Ingelheim Investigational Site

Shimajiri-gun, Okinawa, , Japan

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1237.6.81144 Boehringer Ingelheim Investigational Site

Shimajiri-gun, Okinawa, , Japan

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1237.6.81111 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, , Japan

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1237.6.81145 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, , Japan

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1237.6.81107 Boehringer Ingelheim Investigational Site

Soka, Saitama, , Japan

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1237.6.81133 Boehringer Ingelheim Investigational Site

Takarazuka, Hyogo, , Japan

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1237.6.81122 Boehringer Ingelheim Investigational Site

Takayama, Gifu, , Japan

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1237.6.81143 Boehringer Ingelheim Investigational Site

Tomigusuku, Okinawa, , Japan

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1237.6.81128 Boehringer Ingelheim Investigational Site

Toyonaka, Osaka, , Japan

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1237.6.81124 Boehringer Ingelheim Investigational Site

Uji, Kyoto, , Japan

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1237.6.81130 Boehringer Ingelheim Investigational Site

Yabu, Hyogo, , Japan

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1237.6.81129 Boehringer Ingelheim Investigational Site

Yao, Osaka, , Japan

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1237.6.81119 Boehringer Ingelheim Investigational Site

Yokosuka, Kanagawa, , Japan

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1237.6.47005 Boehringer Ingelheim Investigational Site

Elverum, , Norway

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1237.6.47001 Boehringer Ingelheim Investigational Site

Hønefoss, , Norway

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1237.6.47002 Boehringer Ingelheim Investigational Site

Kløfta, , Norway

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1237.6.47004 Boehringer Ingelheim Investigational Site

Lierskogen, , Norway

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1237.6.47003 Boehringer Ingelheim Investigational Site

Oslo, , Norway

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1237.6.47007 Boehringer Ingelheim Investigational Site

Ski, , Norway

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1237.6.47008 Boehringer Ingelheim Investigational Site

Svelvik, , Norway

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1237.6.40004 Boehringer Ingelheim Investigational Site

Arad, , Romania

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1237.6.40005 Boehringer Ingelheim Investigational Site

Arad, , Romania

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1237.6.40001 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

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1237.6.40002 Boehringer Ingelheim Investigational Site

Bucharest, , Romania

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1237.6.40003 Boehringer Ingelheim Investigational Site

Cluj-Napoca, , Romania

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1237.6.07004 Boehringer Ingelheim Investigational Site

Moscow, , Russia

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1237.6.07005 Boehringer Ingelheim Investigational Site

Moscow, , Russia

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1237.6.07002 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

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1237.6.07003 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

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1237.6.07001 Boehringer Ingelheim Investigational Site

Yaroslavl, , Russia

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1237.6.38103 Boehringer Ingelheim Investigational Site

Belgrade, , Serbia

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1237.6.38104 Boehringer Ingelheim Investigational Site

Belgrade, , Serbia

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1237.6.38105 Boehringer Ingelheim Investigational Site

Belgrade, , Serbia

Site Status

1237.6.38102 Boehringer Ingelheim Investigational Site

Kragujevac, , Serbia

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1237.6.38101 Boehringer Ingelheim Investigational Site

Niš, , Serbia

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1237.6.42101 Boehringer Ingelheim Investigational Site

Bardejov, , Slovakia

Site Status

1237.6.42102 Boehringer Ingelheim Investigational Site

Bojnice, , Slovakia

Site Status

1237.6.42104 Boehringer Ingelheim Investigational Site

Košice, , Slovakia

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1237.6.42107 Boehringer Ingelheim Investigational Site

Nitra, , Slovakia

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1237.6.42103 Boehringer Ingelheim Investigational Site

Spišská Nová Ves, , Slovakia

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1237.6.42106 Boehringer Ingelheim Investigational Site

Žilina, , Slovakia

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1237.6.27002 Boehringer Ingelheim Investigational Site

Bellville, , South Africa

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1237.6.27001 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

Site Status

1237.6.27003 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

Site Status

1237.6.27004 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

Site Status

1237.6.27005 Boehringer Ingelheim Investigational Site

Pretoria, , South Africa

Site Status

1237.6.34008 Boehringer Ingelheim Investigational Site

Badalona (Barcelona), , Spain

Site Status

1237.6.34003 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1237.6.34009 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1237.6.34001 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, , Spain

Site Status

1237.6.34002 Boehringer Ingelheim Investigational Site

Mérida, , Spain

Site Status

1237.6.34005 Boehringer Ingelheim Investigational Site

Pozuelo de Alarcón, , Spain

Site Status

1237.6.34004 Boehringer Ingelheim Investigational Site

Sant Joan d'Alacant, , Spain

Site Status

1237.6.34006 Boehringer Ingelheim Investigational Site

Vic (Barcelona), , Spain

Site Status

1237.6.46003 Boehringer Ingelheim Investigational Site

Boden, , Sweden

Site Status

1237.6.46002 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

Site Status

1237.6.46006 Boehringer Ingelheim Investigational Site

Härnösand, , Sweden

Site Status

1237.6.46005 Boehringer Ingelheim Investigational Site

Höllviken, , Sweden

Site Status

1237.6.46001 Boehringer Ingelheim Investigational Site

Lund, , Sweden

Site Status

1237.6.46004 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1237.6.46007 Boehringer Ingelheim Investigational Site

Uddevalla, , Sweden

Site Status

1237.6.88607 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

Site Status

1237.6.88608 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

Site Status

1237.6.88602 Boehringer Ingelheim Investigational Site

New Taipei City, , Taiwan

Site Status

1237.6.88604 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

Site Status

1237.6.88605 Boehringer Ingelheim Investigational Site

Tainan City, , Taiwan

Site Status

1237.6.88601 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1237.6.88603 Boehringer Ingelheim Investigational Site

Taoyuan, , Taiwan

Site Status

1237.6.90105 Boehringer Ingelheim Investigational Site

Ankara, , Turkey (Türkiye)

Site Status

1237.6.90103 Boehringer Ingelheim Investigational Site

Denizli, , Turkey (Türkiye)

Site Status

1237.6.90104 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

1237.6.90101 Boehringer Ingelheim Investigational Site

Izmir, , Turkey (Türkiye)

Site Status

1237.6.90102 Boehringer Ingelheim Investigational Site

Izmir, , Turkey (Türkiye)

Site Status

1237.6.44002 Boehringer Ingelheim Investigational Site

Blackpool, , United Kingdom

Site Status

1237.6.44009 Boehringer Ingelheim Investigational Site

Blackpool, , United Kingdom

Site Status

1237.6.44007 Boehringer Ingelheim Investigational Site

Bristol, , United Kingdom

Site Status

1237.6.44010 Boehringer Ingelheim Investigational Site

Chertsey, , United Kingdom

Site Status

1237.6.44011 Boehringer Ingelheim Investigational Site

Fleetwood, , United Kingdom

Site Status

1237.6.44001 Boehringer Ingelheim Investigational Site

Manchester, , United Kingdom

Site Status

1237.6.44008 Boehringer Ingelheim Investigational Site

Midsomer Norton, , United Kingdom

Site Status

Countries

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United States Austria Belgium Brazil Canada China Colombia Croatia Germany Hungary India Ireland Japan Norway Romania Russia Serbia Slovakia South Africa Spain Sweden Taiwan Turkey (Türkiye) United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Rabe KF, Chalmers JD, Miravitlles M, Kocks JWH, Tsiligianni I, de la Hoz A, Xue W, Singh D, Ferguson GT, Wedzicha J. Tiotropium/Olodaterol Delays Clinically Important Deterioration Compared with Tiotropium Monotherapy in Patients with Early COPD: a Post Hoc Analysis of the TONADO(R) Trials. Adv Ther. 2021 Jan;38(1):579-593. doi: 10.1007/s12325-020-01528-2. Epub 2020 Nov 11.

Reference Type DERIVED
PMID: 33175291 (View on PubMed)

Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.

Reference Type DERIVED
PMID: 32943047 (View on PubMed)

Andreas S, Bothner U, de la Hoz A, Kloer I, Trampisch M, Alter P. No Influence on Cardiac Arrhythmia or Heart Rate from Long-Term Treatment with Tiotropium/Olodaterol versus Monocomponents by Holter ECG Analysis in Patients with Moderate-to-Very-Severe COPD. Int J Chron Obstruct Pulmon Dis. 2020 Aug 10;15:1945-1953. doi: 10.2147/COPD.S246350. eCollection 2020.

Reference Type DERIVED
PMID: 32848380 (View on PubMed)

Andreas S, McGarvey L, Bothner U, Trampisch M, de la Hoz A, Flezar M, Buhl R, Alter P. Absence of Adverse Effects of Tiotropium/Olodaterol Compared with the Monocomponents on Long-Term Heart Rate and Blood Pressure in Patients with Moderate-to-Very-Severe COPD. Int J Chron Obstruct Pulmon Dis. 2020 Aug 10;15:1935-1944. doi: 10.2147/COPD.S246348. eCollection 2020.

Reference Type DERIVED
PMID: 32848379 (View on PubMed)

Wedzicha JA, Buhl R, Singh D, Vogelmeier CF, de la Hoz A, Xue W, Anzueto A, Calverley PMA. Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO(R)/DYNAGITO(R) Trials. Adv Ther. 2020 Oct;37(10):4266-4279. doi: 10.1007/s12325-020-01438-3. Epub 2020 Aug 10.

Reference Type DERIVED
PMID: 32776202 (View on PubMed)

Buhl R, de la Hoz A, Xue W, Singh D, Ferguson GT. Efficacy of Tiotropium/Olodaterol Compared with Tiotropium as a First-Line Maintenance Treatment in Patients with COPD Who Are Naive to LAMA, LABA and ICS: Pooled Analysis of Four Clinical Trials. Adv Ther. 2020 Oct;37(10):4175-4189. doi: 10.1007/s12325-020-01411-0. Epub 2020 Jul 15.

Reference Type DERIVED
PMID: 32671684 (View on PubMed)

Buhl R, Singh D, de la Hoz A, Xue W, Ferguson GT. Benefits of Tiotropium/Olodaterol Compared with Tiotropium in Patients with COPD Receiving only LAMA at Baseline: Pooled Analysis of the TONADO(R) and OTEMTO(R) Studies. Adv Ther. 2020 Aug;37(8):3485-3499. doi: 10.1007/s12325-020-01373-3. Epub 2020 May 27.

Reference Type DERIVED
PMID: 32462607 (View on PubMed)

Ferguson GT, Buhl R, Bothner U, Hoz A, Voss F, Anzueto A, Calverley PMA. Safety of tiotropium/olodaterol in chronic obstructive pulmonary disease: pooled analysis of three large, 52-week, randomized clinical trials. Respir Med. 2018 Oct;143:67-73. doi: 10.1016/j.rmed.2018.08.012. Epub 2018 Aug 28.

Reference Type DERIVED
PMID: 30261995 (View on PubMed)

Maltais F, Buhl R, Koch A, Amatto VC, Reid J, Gronke L, Bothner U, Voss F, McGarvey L, Ferguson GT. beta-Blockers in COPD: A Cohort Study From the TONADO Research Program. Chest. 2018 Jun;153(6):1315-1325. doi: 10.1016/j.chest.2018.01.008. Epub 2018 Jan 31.

Reference Type DERIVED
PMID: 29355547 (View on PubMed)

Buhl R, Magder S, Bothner U, Tetzlaff K, Voss F, Loaiza L, Vogelmeier CF, McGarvey L. Long-term general and cardiovascular safety of tiotropium/olodaterol in patients with moderate to very severe chronic obstructive pulmonary disease. Respir Med. 2017 Jan;122:58-66. doi: 10.1016/j.rmed.2016.11.011. Epub 2016 Nov 14.

Reference Type DERIVED
PMID: 27993292 (View on PubMed)

Ferguson GT, Flezar M, Korn S, Korducki L, Gronke L, Abrahams R, Buhl R. Efficacy of Tiotropium + Olodaterol in Patients with Chronic Obstructive Pulmonary Disease by Initial Disease Severity and Treatment Intensity: A Post Hoc Analysis. Adv Ther. 2015 Jun;32(6):523-36. doi: 10.1007/s12325-015-0218-0. Epub 2015 Jun 26.

Reference Type DERIVED
PMID: 26112656 (View on PubMed)

Buhl R, Maltais F, Abrahams R, Bjermer L, Derom E, Ferguson G, Flezar M, Hebert J, McGarvey L, Pizzichini E, Reid J, Veale A, Gronke L, Hamilton A, Korducki L, Tetzlaff K, Waitere-Wijker S, Watz H, Bateman E. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4). Eur Respir J. 2015 Apr;45(4):969-79. doi: 10.1183/09031936.00136014. Epub 2015 Jan 8.

Reference Type DERIVED
PMID: 25573406 (View on PubMed)

Other Identifiers

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2009-010669-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1237.6

Identifier Type: -

Identifier Source: org_study_id

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