Clinical trial NCT01964352: Tiotropium + Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 1)
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: 2013-10-17
Enrollment: 813
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
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
timeFrame: 12 weeks
measure: FVC AUC0-3h Response (Change From Baseline)
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Wheat Ridge
country: United States
facility: 1237.25.10504 Boehringer Ingelheim Investigational Site
state: Colorado
city: Clearwater
country: United States
facility: 1237.25.10507 Boehringer Ingelheim Investigational Site
state: Florida
city: Panama City
country: United States
facility: 1237.25.10517 Boehringer Ingelheim Investigational Site
state: Florida
city: Coeur d'Alene
country: United States
facility: 1237.25.10505 Boehringer Ingelheim Investigational Site
state: Idaho
city: Ann Arbor
country: United States
facility: 1237.25.10516 Boehringer Ingelheim Investigational Site
state: Michigan
city: Livonia
country: United States
facility: 1237.25.10509 Boehringer Ingelheim Investigational Site
state: Michigan
city: Charlotte
country: United States
facility: 1237.25.10519 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: 1237.25.10503 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbia
country: United States
facility: 1237.25.10518 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 1237.25.10502 Boehringer Ingelheim Investigational Site
state: Ohio
city: Dublin
country: United States
facility: 1237.25.10511 Boehringer Ingelheim Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: 1237.25.10514 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: 1237.25.10513 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Easley
country: United States
facility: 1237.25.10515 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: 1237.25.10506 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Rock Hill
country: United States
facility: 1237.25.10501 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: 1237.25.10508 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Killeen
country: United States
facility: 1237.25.10520 Boehringer Ingelheim Investigational Site
state: Texas
city: Richmond
country: United States
facility: 1237.25.10510 Boehringer Ingelheim Investigational Site
state: Virginia
city: Spokane
country: United States
facility: 1237.25.10521 Boehringer Ingelheim Investigational Site
state: Washington
city: Brussels
country: Belgium
facility: 1237.25.32004 Boehringer Ingelheim Investigational Site
city: Brussel
country: Belgium
facility: 1237.25.32001 Boehringer Ingelheim Investigational Site
city: Eupen
country: Belgium
facility: 1237.25.32005 Boehringer Ingelheim Investigational Site
city: Lebbeke
country: Belgium
facility: 1237.25.32003 Boehringer Ingelheim Investigational Site
city: Turnhout
country: Belgium
facility: 1237.25.32002 Boehringer Ingelheim Investigational Site
city: Calgary
country: Canada
facility: 1237.25.11508 Boehringer Ingelheim Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: 1237.25.11504 Boehringer Ingelheim Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: 1237.25.11501 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Burlington
country: Canada
facility: 1237.25.11505 Boehringer Ingelheim Investigational Site
state: Ontario
city: Grimsby
country: Canada
facility: 1237.25.11507 Boehringer Ingelheim Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: 1237.25.11510 Boehringer Ingelheim Investigational Site
state: Ontario
city: Sherbrooke,
country: Canada
facility: 1237.25.11509 Boehringer Ingelheim Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: 1237.25.11502 Boehringer Ingelheim Investigational Site
city: Quebec
country: Canada
facility: 1237.25.11506 Boehringer Ingelheim Investigational Site
city: Jindrichuv Hradec
country: Czech Republic
facility: 1237.25.42003 Boehringer Ingelheim Investigational Site
city: Karlovy Vary-Drahovice
country: Czech Republic
facility: 1237.25.42005 Boehringer Ingelheim Investigational Site
city: Neratovice
country: Czech Republic
facility: 1237.25.42002 Boehringer Ingelheim Investigational Site
city: Prague
country: Czech Republic
facility: 1237.25.42001 Boehringer Ingelheim Investigational Site
city: Rokycany
country: Czech Republic
facility: 1237.25.42004 Boehringer Ingelheim Investigational Site
city: Hellerup
country: Denmark
facility: 1237.25.45002 Boehringer Ingelheim Investigational Site
city: Odense
country: Denmark
facility: 1237.25.45001 Boehringer Ingelheim Investigational Site
city: Silkeborg
country: Denmark
facility: 1237.25.45004 Boehringer Ingelheim Investigational Site
city: Ålborg
country: Denmark
facility: 1237.25.45003 Boehringer Ingelheim Investigational Site
city: Pori
country: Finland
facility: 1237.25.35802 Boehringer Ingelheim Investigational Site
city: Turku
country: Finland
facility: 1237.25.35801 Boehringer Ingelheim Investigational Site
city: Turku
country: Finland
facility: 1237.25.35803 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1237.25.49504 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1237.25.49508 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1237.25.49510 Boehringer Ingelheim Investigational Site
city: Großhansdorf
country: Germany
facility: 1237.25.49501 Boehringer Ingelheim Investigational Site
city: Halle/Saale
country: Germany
facility: 1237.25.49505 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1237.25.49506 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1237.25.49515 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1237.25.49509 Boehringer Ingelheim Investigational Site
city: Koblenz
country: Germany
facility: 1237.25.49514 Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: 1237.25.49507 Boehringer Ingelheim Investigational Site
city: Neu-Isenburg
country: Germany
facility: 1237.25.49502 Boehringer Ingelheim Investigational Site
city: Oschersleben
country: Germany
facility: 1237.25.49516 Boehringer Ingelheim Investigational Site
city: Rodgau
country: Germany
facility: 1237.25.49511 Boehringer Ingelheim Investigational Site
city: Rosenheim
country: Germany
facility: 1237.25.49503 Boehringer Ingelheim Investigational Site
city: Teuchern
country: Germany
facility: 1237.25.49513 Boehringer Ingelheim Investigational Site
city: Bloemfontein
country: South Africa
facility: 1237.25.27506 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1237.25.27501 Boehringer Ingelheim Investigational Site
city: Morningside, Sandton
country: South Africa
facility: 1237.25.27504 Boehringer Ingelheim Investigational Site
city: Parow
country: South Africa
facility: 1237.25.27502 Boehringer Ingelheim Investigational Site
city: Pretoria
country: South Africa
facility: 1237.25.27503 Boehringer Ingelheim Investigational Site
city: Umkomaas
country: South Africa
facility: 1237.25.27505 Boehringer Ingelheim Investigational Site
city: Alicante
country: Spain
facility: 1237.25.34003 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1237.25.34007 Boehringer Ingelheim Investigational Site
city: Mérida
country: Spain
facility: 1237.25.34001 Boehringer Ingelheim Investigational Site
city: Pozuelo de Alarcón
country: Spain
facility: 1237.25.34002 Boehringer Ingelheim Investigational Site
city: Vic
country: Spain
facility: 1237.25.34004 Boehringer Ingelheim Investigational Site
city: Bradford
country: United Kingdom
facility: 1237.25.44002 Boehringer Ingelheim Investigational Site
city: Chertsey
country: United Kingdom
facility: 1237.25.44001 Boehringer Ingelheim Investigational Site
city: Chester
country: United Kingdom
facility: 1237.25.44004 Boehringer Ingelheim Investigational Site
city: Chippenham
country: United Kingdom
facility: 1237.25.44005 Boehringer Ingelheim Investigational Site
city: Wolverhampton
country: United Kingdom
facility: 1237.25.44003 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.