Clinical trial NCT01431274: Tiotropium+Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 µg / 5 µg; 5 µg / 5 µg) (Delivered by the Respimat® Inhaler) Compared With the Individual Components (2.5 µg and 5 µg Tiotropium, 5 µg Olodaterol) (Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD). [TOnado TM 1]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-09-09
Enrollment: 2624
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


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

Primary outcomes:
measure: Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169.
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169.
measure: Trough FEV1 Response on Day 170.
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170
measure: Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)
timeFrame: Day 169
Secondary outcomes:
measure: Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)
timeFrame: Day 169
measure: FEV1 AUC(0-3h) Response on Day 1
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment.
measure: FEV1 AUC(0-3h) Response on Day 85
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85.
measure: FEV1 AUC(0-3h) Response on Day 365
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365.
measure: Trough FEV1 Response on Day 15.
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15
measure: Trough FEV1 Response on Day 43
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43.
measure: Trough FEV1 Response on Day 85
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on day 85.
measure: Trough FEV1 Response on Day 169
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on Day 169
measure: Trough FEV1 Response on Day 365
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on day 365
measure: FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 1
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment.
measure: FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 85
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85.
measure: FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 169
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169.
measure: FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 365
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365.
measure: Trough FVC Response on Day 15.
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15
measure: Trough FVC Response on Day 43.
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43
measure: Trough FVC Response on Day 85.
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on day 85
measure: Trough FVC Response on Day 170.
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170
measure: Trough FVC Response on Day 365.
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on Day 365.
measure: FEV1 AUC(0-12h) Response in the Sub-set of Patients With 12-hour Pulmonary Function Test (PFT) on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169.
measure: FEV1 AUC(0-24h) Response in the Sub-set of Patients With 12-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169.
measure: FVC AUC(0-12h) Response in the Sub-set of Patients With 12-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169.
measure: FVC AUC(0-24h) Response in Sub-set of Patients With 24-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169.
measure: Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 85 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)
timeFrame: Day 85
measure: Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 365 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)
timeFrame: Day 365
measure: Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 43 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)
timeFrame: Day 43
measure: Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 85 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)
timeFrame: Day 85
measure: Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 365 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)
timeFrame: Day 365
Other outcomes:
Locations:
city: Jasper
country: United States
facility: 1237.5.01038 Boehringer Ingelheim Investigational Site
state: Alabama
city: Mobile
country: United States
facility: 1237.5.01036 Boehringer Ingelheim Investigational Site
state: Alabama
city: Boulder
country: United States
facility: 1237.5.01015 Boehringer Ingelheim Investigational Site
state: Colorado
city: Wheat Ridge
country: United States
facility: 1237.5.01024 Boehringer Ingelheim Investigational Site
state: Colorado
city: Stamford
country: United States
facility: 1237.5.01034 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Clearwater
country: United States
facility: 1237.5.01003 Boehringer Ingelheim Investigational Site
state: Florida
city: Clearwater
country: United States
facility: 1237.5.01010 Boehringer Ingelheim Investigational Site
state: Florida
city: Panama City
country: United States
facility: 1237.5.01027 Boehringer Ingelheim Investigational Site
state: Florida
city: O'Fallon
country: United States
facility: 1237.5.01031 Boehringer Ingelheim Investigational Site
state: Illinois
city: Opelousas
country: United States
facility: 1237.5.01035 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: 1237.5.01004 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Biddeford
country: United States
facility: 1237.5.01017 Boehringer Ingelheim Investigational Site
state: Maine
city: Columbia
country: United States
facility: 1237.5.01028 Boehringer Ingelheim Investigational Site
state: Maryland
city: Livonia
country: United States
facility: 1237.5.01013 Boehringer Ingelheim Investigational Site
state: Michigan
city: Omaha
country: United States
facility: 1237.5.01019 Boehringer Ingelheim Investigational Site
state: Nebraska
city: Larchmont
country: United States
facility: 1237.5.01025 Boehringer Ingelheim Investigational Site
state: New York
city: Rochester
country: United States
facility: 1237.5.01008 Boehringer Ingelheim Investigational Site
state: New York
city: Raleigh
country: United States
facility: 1237.5.01023 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Tabor City
country: United States
facility: 1237.5.01016 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: 1237.5.01006 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 1237.5.01040 Boehringer Ingelheim Investigational Site
state: Ohio
city: Dayton
country: United States
facility: 1237.5.01039 Boehringer Ingelheim Investigational Site
state: Ohio
city: Toledo
country: United States
facility: 1237.5.01037 Boehringer Ingelheim Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: 1237.5.01009 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Charleston
country: United States
facility: 1237.5.01032 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Johnston
country: United States
facility: 1237.5.01005 Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Easley
country: United States
facility: 1237.5.01021 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Gaffney
country: United States
facility: 1237.5.01012 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: 1237.5.01014 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Ft. Worth
country: United States
facility: 1237.5.01029 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1237.5.01002 Boehringer Ingelheim Investigational Site
state: Texas
city: Lynchburg
country: United States
facility: 1237.5.01026 Boehringer Ingelheim Investigational Site
state: Virginia
city: Spokane
country: United States
facility: 1237.5.01007 Boehringer Ingelheim Investigational Site
state: Washington
city: Tacoma
country: United States
facility: 1237.5.01033 Boehringer Ingelheim Investigational Site
state: Washington
city: Morgantown
country: United States
facility: 1237.5.01001 Boehringer Ingelheim Investigational Site
state: West Virginia
city: Buenos Aires
country: Argentina
facility: 1237.5.54010 Boehringer Ingelheim Investigational Site
city: Caba
country: Argentina
facility: 1237.5.54013 Boehringer Ingelheim Investigational Site
city: Caba
country: Argentina
facility: 1237.5.54016 Boehringer Ingelheim Investigational Site
city: Capital Federal
country: Argentina
facility: 1237.5.54003 Boehringer Ingelheim Investigational Site
city: Cuidad Autonoma de Buenos Airess A
country: Argentina
facility: 1237.5.54002 Boehringer Ingelheim Investigational Site
city: Mar del Plata
country: Argentina
facility: 1237.5.54006 Boehringer Ingelheim Investigational Site
city: Mar del Plata
country: Argentina
facility: 1237.5.54007 Boehringer Ingelheim Investigational Site
city: Mendoza
country: Argentina
facility: 1237.5.54009 Boehringer Ingelheim Investigational Site
city: Monte Grande
country: Argentina
facility: 1237.5.54012 Boehringer Ingelheim Investigational Site
city: Quilmes
country: Argentina
facility: 1237.5.54008 Boehringer Ingelheim Investigational Site
city: Rosario
country: Argentina
facility: 1237.5.54005 Boehringer Ingelheim Investigational Site
city: San Miguel de Tucuman
country: Argentina
facility: 1237.5.54011 Boehringer Ingelheim Investigational Site
city: San Miguel de Tucuma
country: Argentina
facility: 1237.5.54004 Boehringer Ingelheim Investigational Site
city: Toorak Gardens
country: Australia
facility: 1237.5.61001 Boehringer Ingelheim Investigational Site
state: South Australia
city: Woodville
country: Australia
facility: 1237.5.61002 Boehringer Ingelheim Investigational Site
state: South Australia
city: Frankston
country: Australia
facility: 1237.5.61004 Boehringer Ingelheim Investigational Site
state: Victoria
city: Plovdiv
country: Bulgaria
facility: 1237.5.35905 Boehringer Ingelheim Investigational Site
city: Rousse
country: Bulgaria
facility: 1237.5.35901 Boehringer Ingelheim Investigational Site
city: Shumen
country: Bulgaria
facility: 1237.5.35906 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1237.5.35902 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1237.5.35904 Boehringer Ingelheim Investigational Site
city: Troyan
country: Bulgaria
facility: 1237.5.35903 Boehringer Ingelheim Investigational Site
city: Veliko Tarnovo
country: Bulgaria
facility: 1237.5.35908 Boehringer Ingelheim Investigational Site
city: Calgary
country: Canada
facility: 1237.5.02002 Boehringer Ingelheim Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: 1237.5.02001 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: 1237.5.02004 Boehringer Ingelheim Investigational Site
state: Manitoba
city: Burlington
country: Canada
facility: 1237.5.02005 Boehringer Ingelheim Investigational Site
state: Ontario
city: Grimsby
country: Canada
facility: 1237.5.02007 Boehringer Ingelheim Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: 1237.5.02011 Boehringer Ingelheim Investigational Site
state: Ontario
city: Sherbrooke
country: Canada
facility: 1237.5.02008 Boehringer Ingelheim Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: 1237.5.02009 Boehringer Ingelheim Investigational Site
state: Saskatchewan
city: Quebec
country: Canada
facility: 1237.5.02003 Boehringer Ingelheim Investigational Site
city: Quebec
country: Canada
facility: 1237.5.02006 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1237.5.86003 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1237.5.86004 Boehringer Ingelheim Investigational Site
city: Changsha
country: China
facility: 1237.5.86011 Boehringer Ingelheim Investigational Site
city: Changsha
country: China
facility: 1237.5.86012 Boehringer Ingelheim Investigational Site
city: Foshan
country: China
facility: 1237.5.86014 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 1237.5.86001 Boehringer Ingelheim Investigational Site
city: Nan Ning
country: China
facility: 1237.5.86015 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1237.5.86002 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1237.5.86005 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1237.5.86006 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1237.5.86007 Boehringer Ingelheim Investigational Site
city: Shenyang
country: China
facility: 1237.5.86009 Boehringer Ingelheim Investigational Site
city: Wuhan
country: China
facility: 1237.5.86016 Boehringer Ingelheim Investigational Site
city: Xi'An
country: China
facility: 1237.5.86010 Boehringer Ingelheim Investigational Site
city: Yangzhou
country: China
facility: 1237.5.86008 Boehringer Ingelheim Investigational Site
city: Yinchuan
country: China
facility: 1237.5.86017 Boehringer Ingelheim Investigational Site
city: Beroun
country: Czech Republic
facility: 1237.5.42004 Boehringer Ingelheim Investigational Site
city: Cvikov
country: Czech Republic
facility: 1237.5.42002 Boehringer Ingelheim Investigational Site
city: Praha 6
country: Czech Republic
facility: 1237.5.42001 Boehringer Ingelheim Investigational Site
city: Rokycany
country: Czech Republic
facility: 1237.5.42005 Boehringer Ingelheim Investigational Site
city: Znojmo
country: Czech Republic
facility: 1237.5.42003 Boehringer Ingelheim Investigational Site
city: Aalborg
country: Denmark
facility: 1237.5.45002 Boehringer Ingelheim Investigational Site
city: Hvidovre
country: Denmark
facility: 1237.5.45009 Boehringer Ingelheim Investigational Site
city: Kolding
country: Denmark
facility: 1237.5.45007 Boehringer Ingelheim Investigational Site
city: København NV
country: Denmark
facility: 1237.5.45001 Boehringer Ingelheim Investigational Site
city: Næstved
country: Denmark
facility: 1237.5.45011 Boehringer Ingelheim Investigational Site
city: Odense C
country: Denmark
facility: 1237.5.45006 Boehringer Ingelheim Investigational Site
city: Roskilde
country: Denmark
facility: 1237.5.45008 Boehringer Ingelheim Investigational Site
city: Silkeborg
country: Denmark
facility: 1237.5.45003 Boehringer Ingelheim Investigational Site
city: Sønderborg
country: Denmark
facility: 1237.5.45005 Boehringer Ingelheim Investigational Site
city: Vaerløse
country: Denmark
facility: 1237.5.45004 Boehringer Ingelheim Investigational Site
city: Tallin
country: Estonia
facility: 1237.5.37002 Boehringer Ingelheim Investigational Site
city: Tartu
country: Estonia
facility: 1237.5.37001 Boehringer Ingelheim Investigational Site
city: Helsinki
country: Finland
facility: 1237.5.35801 Boehringer Ingelheim Investigational Site
city: Pori
country: Finland
facility: 1237.5.35804 Boehringer Ingelheim Investigational Site
city: Turku
country: Finland
facility: 1237.5.35802 Boehringer Ingelheim Investigational Site
city: Bethune Cedex
country: France
facility: 1237.5.33004 Boehringer Ingelheim Investigational Site
city: Montpellier cedex 5
country: France
facility: 1237.5.33007 Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1237.5.33005 Boehringer Ingelheim Investigational Site
city: Nîmes cedex 9
country: France
facility: 1237.5.33006 Boehringer Ingelheim Investigational Site
city: Perpignan
country: France
facility: 1237.5.33008 Boehringer Ingelheim Investigational Site
city: Saint Pierre Cedex
country: France
facility: 1237.5.33001 Boehringer Ingelheim Investigational Site
city: Strasbourg
country: France
facility: 1237.5.33002 Boehringer Ingelheim Investigational Site
city: Bamberg
country: Germany
facility: 1237.5.49006 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1237.5.49002 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1237.5.49003 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1237.5.49013 Boehringer Ingelheim Investigational Site
city: Erfurt
country: Germany
facility: 1237.5.49011 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1237.5.49005 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1237.5.49010 Boehringer Ingelheim Investigational Site
city: Koblenz
country: Germany
facility: 1237.5.49009 Boehringer Ingelheim Investigational Site
city: Neu-Isenburg
country: Germany
facility: 1237.5.49014 Boehringer Ingelheim Investigational Site
city: Oschersleben
country: Germany
facility: 1237.5.49012 Boehringer Ingelheim Investigational Site
city: Rüdersdorf
country: Germany
facility: 1237.5.49001 Boehringer Ingelheim Investigational Site
city: Weinheim
country: Germany
facility: 1237.5.49004 Boehringer Ingelheim Investigational Site
city: Wiesloch
country: Germany
facility: 1237.5.49008 Boehringer Ingelheim Investigational Site
city: Guatemala
country: Guatemala
facility: 1237.5.50201 Boehringer Ingelheim Investigational Site
city: Guatemala
country: Guatemala
facility: 1237.5.50202 Boehringer Ingelheim Investigational Site
city: Guatemala
country: Guatemala
facility: 1237.5.50203 Boehringer Ingelheim Investigational Site
city: Guatemala
country: Guatemala
facility: 1237.5.50204 Boehringer Ingelheim Investigational Site
city: Guatemala
country: Guatemala
facility: 1237.5.50205 Boehringer Ingelheim Investigational Site
city: Guatemala
country: Guatemala
facility: 1237.5.50206 Boehringer Ingelheim Investigational Site
city: Guatemala
country: Guatemala
facility: 1237.5.50207 Boehringer Ingelheim Investigational Site
city: Debrecen
country: Hungary
facility: 1237.5.36005 Boehringer Ingelheim Investigational Site
city: Deszk
country: Hungary
facility: 1237.5.36001 Boehringer Ingelheim Investigational Site
city: Kapuvar
country: Hungary
facility: 1237.5.36006 Boehringer Ingelheim Investigational Site
city: Szombathely
country: Hungary
facility: 1237.5.36003 Boehringer Ingelheim Investigational Site
city: Törökbalint
country: Hungary
facility: 1237.5.36002 Boehringer Ingelheim Investigational Site
city: Ahmedabad
country: India
facility: 1237.5.91010 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1237.5.91002 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1237.5.91007 Boehringer Ingelheim Investigational Site
city: Coimbatore
country: India
facility: 1237.5.91004 Boehringer Ingelheim Investigational Site
city: Hyderabad
country: India
facility: 1237.5.91011 Boehringer Ingelheim Investigational Site
city: Jaipur
country: India
facility: 1237.5.91001 Boehringer Ingelheim Investigational Site
city: Jaipur
country: India
facility: 1237.5.91008 Boehringer Ingelheim Investigational Site
city: Mysore
country: India
facility: 1237.5.91009 Boehringer Ingelheim Investigational Site
city: Pune
country: India
facility: 1237.5.91006 Boehringer Ingelheim Investigational Site
city: Cagliari
country: Italy
facility: 1237.5.39008 Boehringer Ingelheim Investigational Site
city: Genova
country: Italy
facility: 1237.5.39002 Boehringer Ingelheim Investigational Site
city: Montescano (PV)
country: Italy
facility: 1237.5.39006 Boehringer Ingelheim Investigational Site
city: Monza
country: Italy
facility: 1237.5.39009 Boehringer Ingelheim Investigational Site
city: Parma
country: Italy
facility: 1237.5.39004 Boehringer Ingelheim Investigational Site
city: Pisa
country: Italy
facility: 1237.5.39001 Boehringer Ingelheim Investigational Site
city: Aoba-ku, Sendai, Miyagi
country: Japan
facility: 1237.5.81003 Boehringer Ingelheim Investigational Site
city: Asahikawa, Hokkaido
country: Japan
facility: 1237.5.81001 Boehringer Ingelheim Investigational Site
city: Bunkyo-ku, Tokyo
country: Japan
facility: 1237.5.81006 Boehringer Ingelheim Investigational Site
city: Chuo-ku, Kumamoto, Kumamoto
country: Japan
facility: 1237.5.81044 Boehringer Ingelheim Investigational Site
city: Gifu, Gifu
country: Japan
facility: 1237.5.81035 Boehringer Ingelheim Investigational Site
city: Hakata-ku, Fukuoka, Fukuoka
country: Japan
facility: 1237.5.81017 Boehringer Ingelheim Investigational Site
city: Hamamatsushi, Shizuoka
country: Japan
facility: 1237.5.81031 Boehringer Ingelheim Investigational Site
city: Himeji, Hyogo
country: Japan
facility: 1237.5.81014 Boehringer Ingelheim Investigational Site
city: Ikoma, Nara
country: Japan
facility: 1237.5.81037 Boehringer Ingelheim Investigational Site
city: Inashiki-gun, Ibaraki
country: Japan
facility: 1237.5.81024 Boehringer Ingelheim Investigational Site
city: Itabashi-ku, Tokyo
country: Japan
facility: 1237.5.81008 Boehringer Ingelheim Investigational Site
city: Jonan-ku, Fukuoka, Fukuoka
country: Japan
facility: 1237.5.81016 Boehringer Ingelheim Investigational Site
city: Kagoshima, Kagoshima,
country: Japan
facility: 1237.5.81020 Boehringer Ingelheim Investigational Site
city: Kagoshima, Kagoshima
country: Japan
facility: 1237.5.81021 Boehringer Ingelheim Investigational Site
city: Kamogawa, Chiba
country: Japan
facility: 1237.5.81005 Boehringer Ingelheim Investigational Site
city: Kishiwada, Osaka
country: Japan
facility: 1237.5.81011 Boehringer Ingelheim Investigational Site
city: Kitakyusyu,Fukuoka
country: Japan
facility: 1237.5.81018 Boehringer Ingelheim Investigational Site
city: Koga, Fukuoka
country: Japan
facility: 1237.5.81042 Boehringer Ingelheim Investigational Site
city: Komaki, Aichi
country: Japan
facility: 1237.5.81032 Boehringer Ingelheim Investigational Site
city: Komaki, Aichi
country: Japan
facility: 1237.5.81033 Boehringer Ingelheim Investigational Site
city: Koshi, Kumamoto
country: Japan
facility: 1237.5.81019 Boehringer Ingelheim Investigational Site
city: koto-ku, Tokyo
country: Japan
facility: 1237.5.81027 Boehringer Ingelheim Investigational Site
city: Kuki, Saitama
country: Japan
facility: 1237.5.81025 Boehringer Ingelheim Investigational Site
city: Kure, Hiroshima
country: Japan
facility: 1237.5.81038 Boehringer Ingelheim Investigational Site
city: Kurume, Fukuoka
country: Japan
facility: 1237.5.81015 Boehringer Ingelheim Investigational Site
city: Matsumoto, Nagano
country: Japan
facility: 1237.5.81029 Boehringer Ingelheim Investigational Site
city: Matsumoto, Nagano
country: Japan
facility: 1237.5.81030 Boehringer Ingelheim Investigational Site
city: Matsusaka, Mie
country: Japan
facility: 1237.5.81010 Boehringer Ingelheim Investigational Site
city: Minami-ku. Fukuoka, Fukuoka
country: Japan
facility: 1237.5.81041 Boehringer Ingelheim Investigational Site
city: Morioka, Iwate
country: Japan
facility: 1237.5.81002 Boehringer Ingelheim Investigational Site
city: Nagoya, Aichi
country: Japan
facility: 1237.5.81034 Boehringer Ingelheim Investigational Site
city: Nagoya, Aichi
country: Japan
facility: 1237.5.81036 Boehringer Ingelheim Investigational Site
city: Naka-gun, Ibaraki
country: Japan
facility: 1237.5.81004 Boehringer Ingelheim Investigational Site
city: Okinawa, Urasoe
country: Japan
facility: 1237.5.81022 Boehringer Ingelheim Investigational Site
city: Okinawa, Urasoe
country: Japan
facility: 1237.5.81023 Boehringer Ingelheim Investigational Site
city: Sayama, Osaka
country: Japan
facility: 1237.5.81012 Boehringer Ingelheim Investigational Site
city: Sendai, Miyagi
country: Japan
facility: 1237.5.81045 Boehringer Ingelheim Investigational Site
city: Seto, Aichi
country: Japan
facility: 1237.5.81009 Boehringer Ingelheim Investigational Site
city: Shinagawa, Tokyo
country: Japan
facility: 1237.5.81026 Boehringer Ingelheim Investigational Site
city: Shinjyuku-ku, Tokyo
country: Japan
facility: 1237.5.81007 Boehringer Ingelheim Investigational Site
city: Takamatsu, Kagawa
country: Japan
facility: 1237.5.81039 Boehringer Ingelheim Investigational Site
city: Takamatsu, Kagawa
country: Japan
facility: 1237.5.81040 Boehringer Ingelheim Investigational Site
city: Wakayama, Wakayama
country: Japan
facility: 1237.5.81013 Boehringer Ingelheim Investigational Site
city: Yanagawa-shi, Fukuoka,
country: Japan
facility: 1237.5.81043 Boehringer Ingelheim Investigational Site
city: Yokohama, Kanagawa
country: Japan
facility: 1237.5.81028 Boehringer Ingelheim Investigational Site
city: Bucheon
country: Korea, Republic of
facility: 1237.5.82004 Boehringer Ingelheim Investigational Site
city: Daegu
country: Korea, Republic of
facility: 1237.5.82008 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1237.5.82001 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1237.5.82002 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1237.5.82003 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1237.5.82007 Boehringer Ingelheim Investigational Site
city: Suwon
country: Korea, Republic of
facility: 1237.5.82005 Boehringer Ingelheim Investigational Site
city: Wonju
country: Korea, Republic of
facility: 1237.5.82006 Boehringer Ingelheim Investigational Site
city: Hermosillo
country: Mexico
facility: 1237.5.52002 Boehringer Ingelheim Investigational Site
city: Mexico
country: Mexico
facility: 1237.5.52003 Boehringer Ingelheim Investigational Site
city: Monterrey
country: Mexico
facility: 1237.5.52007 Boehringer Ingelheim Investigational Site
city: Tijuana
country: Mexico
facility: 1237.5.52001 Boehringer Ingelheim Investigational Site
city: Almelo
country: Netherlands
facility: 1237.5.31004 Boehringer Ingelheim Investigational Site
city: Breda
country: Netherlands
facility: 1237.5.31006 Boehringer Ingelheim Investigational Site
city: Eindhoven
country: Netherlands
facility: 1237.5.31001 Boehringer Ingelheim Investigational Site
city: Harderwijk
country: Netherlands
facility: 1237.5.31008 Boehringer Ingelheim Investigational Site
city: Heerlen
country: Netherlands
facility: 1237.5.31007 Boehringer Ingelheim Investigational Site
city: Hengelo
country: Netherlands
facility: 1237.5.31010 Boehringer Ingelheim Investigational Site
city: Hoorn
country: Netherlands
facility: 1237.5.31009 Boehringer Ingelheim Investigational Site
city: Nieuwegein
country: Netherlands
facility: 1237.5.31005 Boehringer Ingelheim Investigational Site
city: Veldhoven
country: Netherlands
facility: 1237.5.31002 Boehringer Ingelheim Investigational Site
city: Zutphen
country: Netherlands
facility: 1237.5.31003 Boehringer Ingelheim Investigational Site
city: Dunedin
country: New Zealand
facility: 1237.5.64002 Boehringer Ingelheim Investigational Site
city: Greenlane East Auckland NZ
country: New Zealand
facility: 1237.5.64001 Boehringer Ingelheim Investigational Site
city: Amadora
country: Portugal
facility: 1237.5.35105 Boehringer Ingelheim Investigational Site
city: Coimbra
country: Portugal
facility: 1237.5.35101 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 1237.5.35102 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 1237.5.35104 Boehringer Ingelheim Investigational Site
city: Porto
country: Portugal
facility: 1237.5.35103 Boehringer Ingelheim Investigational Site
city: Vila Nova de Gaia
country: Portugal
facility: 1237.5.35106 Boehringer Ingelheim Investigational Site
city: Viseu
country: Portugal
facility: 1237.5.35107 Boehringer Ingelheim Investigational Site
city: Gatchina (Leningradskaya oblast)
country: Russian Federation
facility: 1237.5.07001 Boehringer Ingelheim Investigational Site
city: Kazan
country: Russian Federation
facility: 1237.5.07003 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1237.5.07004 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1237.5.07005 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1237.5.07002 Boehringer Ingelheim Investigational Site
city: Golnik
country: Slovenia
facility: 1237.5.38601 Boehringer Ingelheim Investigational Site
city: Golnik
country: Slovenia
facility: 1237.5.38602 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1237.5.90003 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1237.5.90004 Boehringer Ingelheim Investigational Site
city: Izmir
country: Turkey
facility: 1237.5.90002 Boehringer Ingelheim Investigational Site
city: Izmit
country: Turkey
facility: 1237.5.90005 Boehringer Ingelheim Investigational Site
city: Mersin
country: Turkey
facility: 1237.5.90001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.