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

NCT ID: NCT01431274

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

2624 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-09-30

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 Chronic Obstructive Pulmonary Disease (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 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

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

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

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

high dose

Respimat

Intervention Type DEVICE

Respimat inhaler

Interventions

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tiotropium + olodaterol

fixed dose combination

Intervention Type DRUG

tiotropium

low dose

Intervention Type DRUG

olodaterol

one dose only

Intervention Type DRUG

tiotropium

high dose

Intervention Type DRUG

tiotropium + olodaterol

fixed dose combination

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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1237.5.01038 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

Site Status

1237.5.01036 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Site Status

1237.5.01015 Boehringer Ingelheim Investigational Site

Boulder, Colorado, United States

Site Status

1237.5.01024 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Site Status

1237.5.01034 Boehringer Ingelheim Investigational Site

Stamford, Connecticut, United States

Site Status

1237.5.01003 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Site Status

1237.5.01010 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Site Status

1237.5.01027 Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

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1237.5.01031 Boehringer Ingelheim Investigational Site

O'Fallon, Illinois, United States

Site Status

1237.5.01035 Boehringer Ingelheim Investigational Site

Opelousas, Louisiana, United States

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1237.5.01004 Boehringer Ingelheim Investigational Site

Shreveport, Louisiana, United States

Site Status

1237.5.01017 Boehringer Ingelheim Investigational Site

Biddeford, Maine, United States

Site Status

1237.5.01028 Boehringer Ingelheim Investigational Site

Columbia, Maryland, United States

Site Status

1237.5.01013 Boehringer Ingelheim Investigational Site

Livonia, Michigan, United States

Site Status

1237.5.01019 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

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1237.5.01025 Boehringer Ingelheim Investigational Site

Larchmont, New York, United States

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1237.5.01008 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

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1237.5.01023 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

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1237.5.01016 Boehringer Ingelheim Investigational Site

Tabor City, North Carolina, United States

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1237.5.01006 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

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1237.5.01040 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

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1237.5.01039 Boehringer Ingelheim Investigational Site

Dayton, Ohio, United States

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1237.5.01037 Boehringer Ingelheim Investigational Site

Toledo, Ohio, United States

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1237.5.01009 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

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1237.5.01032 Boehringer Ingelheim Investigational Site

Charleston, Pennsylvania, United States

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1237.5.01005 Boehringer Ingelheim Investigational Site

Johnston, Rhode Island, United States

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1237.5.01021 Boehringer Ingelheim Investigational Site

Easley, South Carolina, United States

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1237.5.01012 Boehringer Ingelheim Investigational Site

Gaffney, South Carolina, United States

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1237.5.01014 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

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1237.5.01029 Boehringer Ingelheim Investigational Site

Fort Worth, Texas, United States

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1237.5.01002 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

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1237.5.01026 Boehringer Ingelheim Investigational Site

Lynchburg, Virginia, United States

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1237.5.01007 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

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1237.5.01033 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

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1237.5.01001 Boehringer Ingelheim Investigational Site

Morgantown, West Virginia, United States

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1237.5.54010 Boehringer Ingelheim Investigational Site

Buenos Aires, , Argentina

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1237.5.54013 Boehringer Ingelheim Investigational Site

Caba, , Argentina

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1237.5.54016 Boehringer Ingelheim Investigational Site

Caba, , Argentina

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1237.5.54003 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

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1237.5.54002 Boehringer Ingelheim Investigational Site

Cuidad Autonoma de Buenos Airess A, , Argentina

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1237.5.54006 Boehringer Ingelheim Investigational Site

Mar del Plata, , Argentina

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1237.5.54007 Boehringer Ingelheim Investigational Site

Mar del Plata, , Argentina

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1237.5.54009 Boehringer Ingelheim Investigational Site

Mendoza, , Argentina

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1237.5.54012 Boehringer Ingelheim Investigational Site

Monte Grande, , Argentina

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1237.5.54008 Boehringer Ingelheim Investigational Site

Quilmes, , Argentina

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1237.5.54005 Boehringer Ingelheim Investigational Site

Rosario, , Argentina

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1237.5.54004 Boehringer Ingelheim Investigational Site

San Miguel de Tucuma, , Argentina

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1237.5.54011 Boehringer Ingelheim Investigational Site

San Miguel de Tucumán, , Argentina

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1237.5.61001 Boehringer Ingelheim Investigational Site

Toorak Gardens, South Australia, Australia

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1237.5.61002 Boehringer Ingelheim Investigational Site

Woodville, South Australia, Australia

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1237.5.61004 Boehringer Ingelheim Investigational Site

Frankston, Victoria, Australia

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1237.5.35905 Boehringer Ingelheim Investigational Site

Plovdiv, , Bulgaria

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1237.5.35901 Boehringer Ingelheim Investigational Site

Rousse, , Bulgaria

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1237.5.35906 Boehringer Ingelheim Investigational Site

Shumen, , Bulgaria

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1237.5.35902 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

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1237.5.35904 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

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1237.5.35903 Boehringer Ingelheim Investigational Site

Troyan Municipality, , Bulgaria

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1237.5.35908 Boehringer Ingelheim Investigational Site

Veliko Tarnovo, , Bulgaria

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1237.5.02002 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

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1237.5.02001 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

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1237.5.02004 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

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1237.5.02005 Boehringer Ingelheim Investigational Site

Burlington, Ontario, Canada

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1237.5.02007 Boehringer Ingelheim Investigational Site

Grimsby, Ontario, Canada

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1237.5.02011 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

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1237.5.02003 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

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1237.5.02006 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

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1237.5.02008 Boehringer Ingelheim Investigational Site

Sherbrooke, Quebec, Canada

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1237.5.02009 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

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1237.5.86003 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1237.5.86004 Boehringer Ingelheim Investigational Site

Beijing, , China

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1237.5.86011 Boehringer Ingelheim Investigational Site

Changsha, , China

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1237.5.86012 Boehringer Ingelheim Investigational Site

Changsha, , China

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1237.5.86014 Boehringer Ingelheim Investigational Site

Foshan, , China

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1237.5.86001 Boehringer Ingelheim Investigational Site

Guangzhou, , China

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1237.5.86015 Boehringer Ingelheim Investigational Site

Nanning, , China

Site Status

1237.5.86002 Boehringer Ingelheim Investigational Site

Shanghai, , China

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1237.5.86005 Boehringer Ingelheim Investigational Site

Shanghai, , China

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1237.5.86006 Boehringer Ingelheim Investigational Site

Shanghai, , China

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1237.5.86007 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1237.5.86009 Boehringer Ingelheim Investigational Site

Shenyang, , China

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1237.5.86016 Boehringer Ingelheim Investigational Site

Wuhan, , China

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1237.5.86010 Boehringer Ingelheim Investigational Site

Xi'an, , China

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1237.5.86008 Boehringer Ingelheim Investigational Site

Yangzhou, , China

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1237.5.86017 Boehringer Ingelheim Investigational Site

Yinchuan, , China

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1237.5.42004 Boehringer Ingelheim Investigational Site

Beroun, , Czechia

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1237.5.42002 Boehringer Ingelheim Investigational Site

Cvikov, , Czechia

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1237.5.42001 Boehringer Ingelheim Investigational Site

Prague, , Czechia

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1237.5.42005 Boehringer Ingelheim Investigational Site

Rokycany, , Czechia

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1237.5.42003 Boehringer Ingelheim Investigational Site

Znojmo, , Czechia

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1237.5.45002 Boehringer Ingelheim Investigational Site

Aalborg, , Denmark

Site Status

1237.5.45009 Boehringer Ingelheim Investigational Site

Hvidovre, , Denmark

Site Status

1237.5.45007 Boehringer Ingelheim Investigational Site

Kolding, , Denmark

Site Status

1237.5.45001 Boehringer Ingelheim Investigational Site

København NV, , Denmark

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1237.5.45011 Boehringer Ingelheim Investigational Site

Næstved, , Denmark

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1237.5.45006 Boehringer Ingelheim Investigational Site

Odense C, , Denmark

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1237.5.45008 Boehringer Ingelheim Investigational Site

Roskilde, , Denmark

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1237.5.45003 Boehringer Ingelheim Investigational Site

Silkeborg, , Denmark

Site Status

1237.5.45005 Boehringer Ingelheim Investigational Site

Sønderborg, , Denmark

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1237.5.45004 Boehringer Ingelheim Investigational Site

Vaerløse, , Denmark

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1237.5.37002 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

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1237.5.37001 Boehringer Ingelheim Investigational Site

Tartu, , Estonia

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1237.5.35801 Boehringer Ingelheim Investigational Site

Helsinki, , Finland

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1237.5.35804 Boehringer Ingelheim Investigational Site

Pori, , Finland

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1237.5.35802 Boehringer Ingelheim Investigational Site

Turku, , Finland

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1237.5.33004 Boehringer Ingelheim Investigational Site

Béthune, , France

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1237.5.33007 Boehringer Ingelheim Investigational Site

Montpellier, , France

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1237.5.33005 Boehringer Ingelheim Investigational Site

Nantes, , France

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1237.5.33006 Boehringer Ingelheim Investigational Site

Nîmes, , France

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1237.5.33008 Boehringer Ingelheim Investigational Site

Perpignan, , France

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1237.5.33001 Boehringer Ingelheim Investigational Site

Saint-Pierre, , France

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1237.5.33002 Boehringer Ingelheim Investigational Site

Strasbourg, , France

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1237.5.49006 Boehringer Ingelheim Investigational Site

Bamberg, , Germany

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1237.5.49002 Boehringer Ingelheim Investigational Site

Berlin, , Germany

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1237.5.49003 Boehringer Ingelheim Investigational Site

Berlin, , Germany

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1237.5.49013 Boehringer Ingelheim Investigational Site

Berlin, , Germany

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1237.5.49011 Boehringer Ingelheim Investigational Site

Erfurt, , Germany

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1237.5.49005 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

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1237.5.49010 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

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1237.5.49009 Boehringer Ingelheim Investigational Site

Koblenz, , Germany

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1237.5.49014 Boehringer Ingelheim Investigational Site

Neu-Isenburg, , Germany

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1237.5.49012 Boehringer Ingelheim Investigational Site

Oschersleben, , Germany

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1237.5.49001 Boehringer Ingelheim Investigational Site

Rüdersdorf, , Germany

Site Status

1237.5.49004 Boehringer Ingelheim Investigational Site

Weinheim, , Germany

Site Status

1237.5.49008 Boehringer Ingelheim Investigational Site

Wiesloch, , Germany

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1237.5.50201 Boehringer Ingelheim Investigational Site

Guatemala City, , Guatemala

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1237.5.50202 Boehringer Ingelheim Investigational Site

Guatemala City, , Guatemala

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1237.5.50203 Boehringer Ingelheim Investigational Site

Guatemala City, , Guatemala

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1237.5.50204 Boehringer Ingelheim Investigational Site

Guatemala City, , Guatemala

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1237.5.50205 Boehringer Ingelheim Investigational Site

Guatemala City, , Guatemala

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1237.5.50206 Boehringer Ingelheim Investigational Site

Guatemala City, , Guatemala

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1237.5.50207 Boehringer Ingelheim Investigational Site

Guatemala City, , Guatemala

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1237.5.36005 Boehringer Ingelheim Investigational Site

Debrecen, , Hungary

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1237.5.36001 Boehringer Ingelheim Investigational Site

Deszk, , Hungary

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1237.5.36006 Boehringer Ingelheim Investigational Site

Kapuvár, , Hungary

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1237.5.36003 Boehringer Ingelheim Investigational Site

Szombathely, , Hungary

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1237.5.36002 Boehringer Ingelheim Investigational Site

Törökbálint, , Hungary

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1237.5.91010 Boehringer Ingelheim Investigational Site

Ahmedabad, , India

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1237.5.91002 Boehringer Ingelheim Investigational Site

Bangalore, , India

Site Status

1237.5.91007 Boehringer Ingelheim Investigational Site

Bangalore, , India

Site Status

1237.5.91004 Boehringer Ingelheim Investigational Site

Coimbatore, , India

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1237.5.91011 Boehringer Ingelheim Investigational Site

Hyderabad, , India

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1237.5.91001 Boehringer Ingelheim Investigational Site

Jaipur, , India

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1237.5.91008 Boehringer Ingelheim Investigational Site

Jaipur, , India

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1237.5.91009 Boehringer Ingelheim Investigational Site

Mysore, , India

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1237.5.91006 Boehringer Ingelheim Investigational Site

Pune, , India

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1237.5.39008 Boehringer Ingelheim Investigational Site

Cagliari, , Italy

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1237.5.39002 Boehringer Ingelheim Investigational Site

Genova, , Italy

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1237.5.39006 Boehringer Ingelheim Investigational Site

Montescano (PV), , Italy

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1237.5.39009 Boehringer Ingelheim Investigational Site

Monza, , Italy

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1237.5.39004 Boehringer Ingelheim Investigational Site

Parma, , Italy

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1237.5.39001 Boehringer Ingelheim Investigational Site

Pisa, , Italy

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1237.5.81003 Boehringer Ingelheim Investigational Site

Aoba-ku, Sendai, Miyagi, , Japan

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1237.5.81001 Boehringer Ingelheim Investigational Site

Asahikawa, Hokkaido, , Japan

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1237.5.81006 Boehringer Ingelheim Investigational Site

Bunkyo-ku, Tokyo, , Japan

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1237.5.81044 Boehringer Ingelheim Investigational Site

Chuo-ku, Kumamoto, Kumamoto, , Japan

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1237.5.81035 Boehringer Ingelheim Investigational Site

Gifu, Gifu, , Japan

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1237.5.81017 Boehringer Ingelheim Investigational Site

Hakata-ku, Fukuoka, Fukuoka, , Japan

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1237.5.81031 Boehringer Ingelheim Investigational Site

Hamamatsushi, Shizuoka, , Japan

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1237.5.81014 Boehringer Ingelheim Investigational Site

Himeji, Hyogo, , Japan

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1237.5.81037 Boehringer Ingelheim Investigational Site

Ikoma, Nara, , Japan

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1237.5.81024 Boehringer Ingelheim Investigational Site

Inashiki-gun, Ibaraki, , Japan

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1237.5.81008 Boehringer Ingelheim Investigational Site

Itabashi-ku, Tokyo, , Japan

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1237.5.81016 Boehringer Ingelheim Investigational Site

Jonan-ku, Fukuoka, Fukuoka, , Japan

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1237.5.81020 Boehringer Ingelheim Investigational Site

Kagoshima, Kagoshima,, , Japan

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1237.5.81021 Boehringer Ingelheim Investigational Site

Kagoshima, Kagoshima, , Japan

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1237.5.81005 Boehringer Ingelheim Investigational Site

Kamogawa, Chiba, , Japan

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1237.5.81011 Boehringer Ingelheim Investigational Site

Kishiwada, Osaka, , Japan

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1237.5.81018 Boehringer Ingelheim Investigational Site

Kitakyusyu,Fukuoka, , Japan

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1237.5.81042 Boehringer Ingelheim Investigational Site

Koga, Fukuoka, , Japan

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1237.5.81032 Boehringer Ingelheim Investigational Site

Komaki, Aichi, , Japan

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1237.5.81033 Boehringer Ingelheim Investigational Site

Komaki, Aichi, , Japan

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1237.5.81019 Boehringer Ingelheim Investigational Site

Koshi, Kumamoto, , Japan

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1237.5.81027 Boehringer Ingelheim Investigational Site

Koto-ku, Tokyo, , Japan

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1237.5.81025 Boehringer Ingelheim Investigational Site

Kuki, Saitama, , Japan

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1237.5.81038 Boehringer Ingelheim Investigational Site

Kure, Hiroshima, , Japan

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1237.5.81015 Boehringer Ingelheim Investigational Site

Kurume, Fukuoka, , Japan

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1237.5.81029 Boehringer Ingelheim Investigational Site

Matsumoto, Nagano, , Japan

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1237.5.81030 Boehringer Ingelheim Investigational Site

Matsumoto, Nagano, , Japan

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1237.5.81010 Boehringer Ingelheim Investigational Site

Matsusaka, Mie, , Japan

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1237.5.81041 Boehringer Ingelheim Investigational Site

Minami-ku. Fukuoka, Fukuoka, , Japan

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1237.5.81002 Boehringer Ingelheim Investigational Site

Morioka, Iwate, , Japan

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1237.5.81034 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

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1237.5.81036 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

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1237.5.81004 Boehringer Ingelheim Investigational Site

Naka-gun, Ibaraki, , Japan

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1237.5.81022 Boehringer Ingelheim Investigational Site

Okinawa, Urasoe, , Japan

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1237.5.81023 Boehringer Ingelheim Investigational Site

Okinawa, Urasoe, , Japan

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1237.5.81012 Boehringer Ingelheim Investigational Site

Sayama, Osaka, , Japan

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1237.5.81045 Boehringer Ingelheim Investigational Site

Sendai, Miyagi, , Japan

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1237.5.81009 Boehringer Ingelheim Investigational Site

Seto, Aichi, , Japan

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1237.5.81026 Boehringer Ingelheim Investigational Site

Shinagawa, Tokyo, , Japan

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1237.5.81007 Boehringer Ingelheim Investigational Site

Shinjyuku-ku, Tokyo, , Japan

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1237.5.81039 Boehringer Ingelheim Investigational Site

Takamatsu, Kagawa, , Japan

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1237.5.81040 Boehringer Ingelheim Investigational Site

Takamatsu, Kagawa, , Japan

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1237.5.81013 Boehringer Ingelheim Investigational Site

Wakayama, Wakayama, , Japan

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1237.5.81043 Boehringer Ingelheim Investigational Site

Yanagawa-shi, Fukuoka,, , Japan

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1237.5.81028 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, , Japan

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1237.5.52002 Boehringer Ingelheim Investigational Site

Hermosillo, , Mexico

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1237.5.52003 Boehringer Ingelheim Investigational Site

México, , Mexico

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1237.5.52007 Boehringer Ingelheim Investigational Site

Monterrey, , Mexico

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1237.5.52001 Boehringer Ingelheim Investigational Site

Tijuana, , Mexico

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1237.5.31004 Boehringer Ingelheim Investigational Site

Almelo, , Netherlands

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1237.5.31006 Boehringer Ingelheim Investigational Site

Breda, , Netherlands

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1237.5.31001 Boehringer Ingelheim Investigational Site

Eindhoven, , Netherlands

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1237.5.31008 Boehringer Ingelheim Investigational Site

Harderwijk, , Netherlands

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1237.5.31007 Boehringer Ingelheim Investigational Site

Heerlen, , Netherlands

Site Status

1237.5.31010 Boehringer Ingelheim Investigational Site

Hengelo, , Netherlands

Site Status

1237.5.31009 Boehringer Ingelheim Investigational Site

Hoorn, , Netherlands

Site Status

1237.5.31005 Boehringer Ingelheim Investigational Site

Nieuwegein, , Netherlands

Site Status

1237.5.31002 Boehringer Ingelheim Investigational Site

Veldhoven, , Netherlands

Site Status

1237.5.31003 Boehringer Ingelheim Investigational Site

Zutphen, , Netherlands

Site Status

1237.5.64002 Boehringer Ingelheim Investigational Site

Dunedin, , New Zealand

Site Status

1237.5.64001 Boehringer Ingelheim Investigational Site

Greenlane East Auckland NZ, , New Zealand

Site Status

1237.5.35105 Boehringer Ingelheim Investigational Site

Amadora, , Portugal

Site Status

1237.5.35101 Boehringer Ingelheim Investigational Site

Coimbra, , Portugal

Site Status

1237.5.35102 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

Site Status

1237.5.35104 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

Site Status

1237.5.35103 Boehringer Ingelheim Investigational Site

Porto, , Portugal

Site Status

1237.5.35106 Boehringer Ingelheim Investigational Site

Vila Nova de Gaia, , Portugal

Site Status

1237.5.35107 Boehringer Ingelheim Investigational Site

Viseu, , Portugal

Site Status

1237.5.07001 Boehringer Ingelheim Investigational Site

Gatchina (Leningradskaya Oblast), , Russia

Site Status

1237.5.07003 Boehringer Ingelheim Investigational Site

Kazan', , Russia

Site Status

1237.5.07004 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1237.5.07005 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1237.5.07002 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1237.5.38601 Boehringer Ingelheim Investigational Site

Golnik, , Slovenia

Site Status

1237.5.38602 Boehringer Ingelheim Investigational Site

Golnik, , Slovenia

Site Status

1237.5.82004 Boehringer Ingelheim Investigational Site

Bucheon-si, , South Korea

Site Status

1237.5.82008 Boehringer Ingelheim Investigational Site

Daegu, , South Korea

Site Status

1237.5.82001 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1237.5.82002 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1237.5.82003 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1237.5.82007 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1237.5.82005 Boehringer Ingelheim Investigational Site

Suwon, , South Korea

Site Status

1237.5.82006 Boehringer Ingelheim Investigational Site

Wŏnju, , South Korea

Site Status

1237.5.90003 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

1237.5.90004 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

1237.5.90002 Boehringer Ingelheim Investigational Site

Izmir, , Turkey (Türkiye)

Site Status

1237.5.90005 Boehringer Ingelheim Investigational Site

İzmit, , Turkey (Türkiye)

Site Status

1237.5.90001 Boehringer Ingelheim Investigational Site

Mersin, , Turkey (Türkiye)

Site Status

Countries

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United States Argentina Australia Bulgaria Canada China Czechia Denmark Estonia Finland France Germany Guatemala Hungary India Italy Japan Mexico Netherlands New Zealand Portugal Russia Slovenia South Korea Turkey (Türkiye)

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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2009-010668-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1237.5

Identifier Type: -

Identifier Source: org_study_id

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