Clinical trial NCT02006732: Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)
Official title: A Randomised, Double-blind, Placebo- and Active-controlled Parallel Group Study to Assess the Efficacy of 12 Weeks of Once Daily Treatment of Two Doses of Orally Inhaled Tiotropium+ Olodaterol Fixed Dose Combination (Delivered by the Respimat Inhaler) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-12-10
Enrollment: 809
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 objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD.


Eligibility criteria: Inclusion criteria:

* Diagnosis chronic obstructive pulmonary disease
* Relatively stable airway obstruction with post FEV1 \>=30 and \< 80% predicted normal and post FEV1/ FVC \< 70%
* Male or female patients, 40 years of age or more
* Smoking history more than 10 pack years

Exclusion criteria:

* Significant diseases other than COPD
* History of asthma
* COPD exacerbation in previous 3 months
* Completion of pulmonary rehabilitation program within previous 6 weeks or current participation in pulmonary rehabilitation program.
* Pregnant or nursing women
* Patients unable to comply with pulmonary medication restrictions

Primary outcomes:
measure: FEV1 AUC0-3h Response
timeFrame: baseline and 12 weeks
measure: Trough FEV1 Response (Change From Baseline)
timeFrame: baseline and 12 weeks
measure: St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Data From This Individual Study
timeFrame: 12 weeks treatment
measure: St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352
timeFrame: 12 weeks treatment
Secondary outcomes:
measure: Trough Forced Vital Capacity (FVC) Response (Change From Baseline)
timeFrame: baseline and 12 weeks
measure: TDI Focal Score Based on Data From This Individual Study
timeFrame: 12 weeks
measure: TDI Focal Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352
timeFrame: 12 weeks
measure: FVC AUC0-3h Response (Change From Baseline)
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Jasper
country: United States
facility: 1237.26.10620 Boehringer Ingelheim Investigational Site
state: Alabama
city: Stamford
country: United States
facility: 1237.26.10618 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Clearwater
country: United States
facility: 1237.26.10619 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 1237.26.10614 Boehringer Ingelheim Investigational Site
state: Florida
city: Duluth
country: United States
facility: 1237.26.10616 Boehringer Ingelheim Investigational Site
state: Georgia
city: St. Louis
country: United States
facility: 1237.26.10613 Boehringer Ingelheim Investigational Site
state: Missouri
city: Greensboro
country: United States
facility: 1237.26.10615 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: 1237.26.10603 Boehringer Ingelheim Investigational Site
state: Ohio
city: Dayton
country: United States
facility: 1237.26.10621 Boehringer Ingelheim Investigational Site
state: Ohio
city: Toledo
country: United States
facility: 1237.26.10612 Boehringer Ingelheim Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: 1237.26.10605 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: 1237.26.10606 Boehringer Ingelheim Investigational Site
state: Oregon
city: East Providence
country: United States
facility: 1237.26.10610 Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Gaffney
country: United States
facility: 1237.26.10607 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: 1237.26.10617 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: 1237.26.10608 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Union
country: United States
facility: 1237.26.10604 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Boerne
country: United States
facility: 1237.26.10609 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1237.26.10602 Boehringer Ingelheim Investigational Site
state: Texas
city: Morgantown
country: United States
facility: 1237.26.10601 Boehringer Ingelheim Investigational Site
state: West Virginia
city: Concord
country: Australia
facility: 1237.26.61004 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Daw Park
country: Australia
facility: 1237.26.61002 Boehringer Ingelheim Investigational Site
state: South Australia
city: Toorak Gardens
country: Australia
facility: 1237.26.61003 Boehringer Ingelheim Investigational Site
state: South Australia
city: Woodville
country: Australia
facility: 1237.26.61007 Boehringer Ingelheim Investigational Site
state: South Australia
city: Murdoch
country: Australia
facility: 1237.26.61005 Boehringer Ingelheim Investigational Site
state: Western Australia
city: Nedlands
country: Australia
facility: 1237.26.61001 Boehringer Ingelheim Investigational Site
state: Western Australia
city: Feldbach
country: Austria
facility: 1237.26.43004 Boehringer Ingelheim Investigational Site
city: Grieskirchen
country: Austria
facility: 1237.26.43002 Boehringer Ingelheim Investigational Site
city: Linz
country: Austria
facility: 1237.26.43003 Boehringer Ingelheim Investigational Site
city: Linz
country: Austria
facility: 1237.26.43006 Boehringer Ingelheim Investigational Site
city: Thalheim bei Wels
country: Austria
facility: 1237.26.43001 Boehringer Ingelheim Investigational Site
city: Moncton
country: Canada
facility: 1237.26.11605 Boehringer Ingelheim Investigational Site
state: New Brunswick
city: Courtice
country: Canada
facility: 1237.26.11609 Boehringer Ingelheim Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: 1237.26.11608 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1237.26.11606 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1237.26.11607 Boehringer Ingelheim Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: 1237.26.11601 Boehringer Ingelheim Investigational Site
state: Ontario
city: Mirabel
country: Canada
facility: 1237.26.11611 Boehringer Ingelheim Investigational Site
state: Quebec
city: Point Claire
country: Canada
facility: 1237.26.11602 Boehringer Ingelheim Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: 1237.26.11603 Boehringer Ingelheim Investigational Site
state: Quebec
city: Bamberg
country: Germany
facility: 1237.26.49610 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1237.26.49611 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1237.26.49616 Boehringer Ingelheim Investigational Site
city: Bochum
country: Germany
facility: 1237.26.49609 Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: 1237.26.49607 Boehringer Ingelheim Investigational Site
city: Frankfurt
country: Germany
facility: 1237.26.49612 Boehringer Ingelheim Investigational Site
city: Halberstadt
country: Germany
facility: 1237.26.49615 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1237.26.49606 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1237.26.49608 Boehringer Ingelheim Investigational Site
city: Hettstedt
country: Germany
facility: 1237.26.49603 Boehringer Ingelheim Investigational Site
city: Leipzig
country: Germany
facility: 1237.26.49604 Boehringer Ingelheim Investigational Site
city: Leipzig
country: Germany
facility: 1237.26.49605 Boehringer Ingelheim Investigational Site
city: Lübeck
country: Germany
facility: 1237.26.49601 Boehringer Ingelheim Investigational Site
city: Rüdersdorf
country: Germany
facility: 1237.26.49602 Boehringer Ingelheim Investigational Site
city: Schwerin
country: Germany
facility: 1237.26.49614 Boehringer Ingelheim Investigational Site
city: Wiesloch
country: Germany
facility: 1237.26.49613 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1237.26.30005 Boehringer Ingelheim Investigational Site
city: Heraklion
country: Greece
facility: 1237.26.30002 Boehringer Ingelheim Investigational Site
city: Nafplio
country: Greece
facility: 1237.26.30001 Boehringer Ingelheim Investigational Site
city: Serres
country: Greece
facility: 1237.26.30004 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 1237.26.30003 Boehringer Ingelheim Investigational Site
city: Greenlane East Auckland NZ
country: New Zealand
facility: 1237.26.64001 Boehringer Ingelheim Investigational Site
city: Hamar
country: Norway
facility: 1237.26.47003 Boehringer Ingelheim Investigational Site
city: Hønefoss
country: Norway
facility: 1237.26.47001 Boehringer Ingelheim Investigational Site
city: Kløfta
country: Norway
facility: 1237.26.47002 Boehringer Ingelheim Investigational Site
city: Lierskogen
country: Norway
facility: 1237.26.47004 Boehringer Ingelheim Investigational Site
city: Bardejov
country: Slovakia
facility: 1237.26.42103 Boehringer Ingelheim Investigational Site
city: Humenne
country: Slovakia
facility: 1237.26.42104 Boehringer Ingelheim Investigational Site
city: Spisska Nova Ves
country: Slovakia
facility: 1237.26.42102 Boehringer Ingelheim Investigational Site
city: Vysne Hagy
country: Slovakia
facility: 1237.26.42101 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1237.26.27601 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1237.26.27602 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1237.26.27604 Boehringer Ingelheim Investigational Site
city: Durban
country: South Africa
facility: 1237.26.27605 Boehringer Ingelheim Investigational Site
city: Höllviken
country: Sweden
facility: 1237.26.46004 Boehringer Ingelheim Investigational Site
city: Lund
country: Sweden
facility: 1237.26.46001 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1237.26.46002 Boehringer Ingelheim Investigational Site
city: Uddevalla
country: Sweden
facility: 1237.26.46003 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
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: Singh D, Gaga M, Schmidt O, Bjermer L, Gronke L, Voss F, Ferguson GT. Effects of tiotropium + olodaterol versus tiotropium or placebo by COPD disease severity and previous treatment history in the OTEMTO(R) studies. Respir Res. 2016 Jun 18;17(1):73. doi: 10.1186/s12931-016-0387-7.
citation: Singh D, Ferguson GT, Bolitschek J, Gronke L, Hallmann C, Bennett N, Abrahams R, Schmidt O, Bjermer L. Tiotropium + olodaterol shows clinically meaningful improvements in quality of life. Respir Med. 2015 Oct;109(10):1312-9. doi: 10.1016/j.rmed.2015.08.002. Epub 2015 Aug 12.