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Tiotropium + Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 1)

NCT ID: NCT01964352

Last Updated: 2015-11-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

813 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-11-30

Brief Summary

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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.

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

Once daily 2 puffs solution for inhalation Respimat

Group Type EXPERIMENTAL

tiotropium

Intervention Type DRUG

fixed dose combination

olodaterol

Intervention Type DRUG

fixed dose combination

tiotropium + olodaterol high dose

Once daily 2 puffs solution for inhalation Respimat

Group Type EXPERIMENTAL

tiotropium

Intervention Type DRUG

fixed dose combination

olodaterol

Intervention Type DRUG

fixed dose combination

tiotropium

Once daily 2 puffs solution for inhalation Respimat

Group Type ACTIVE_COMPARATOR

tiotropium

Intervention Type DRUG

placebo

Once daily 2 puffs solution for inhalation Respimat

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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tiotropium

fixed dose combination

Intervention Type DRUG

placebo

Intervention Type DRUG

olodaterol

fixed dose combination

Intervention Type DRUG

tiotropium

fixed dose combination

Intervention Type DRUG

tiotropium

Intervention Type DRUG

olodaterol

fixed dose combination

Intervention Type DRUG

Eligibility Criteria

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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
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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1237.25.10504 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Site Status

1237.25.10507 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Site Status

1237.25.10517 Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

Site Status

1237.25.10505 Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, United States

Site Status

1237.25.10516 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

Site Status

1237.25.10509 Boehringer Ingelheim Investigational Site

Livonia, Michigan, United States

Site Status

1237.25.10519 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Site Status

1237.25.10503 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Site Status

1237.25.10518 Boehringer Ingelheim Investigational Site

Columbia, Ohio, United States

Site Status

1237.25.10502 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Site Status

1237.25.10511 Boehringer Ingelheim Investigational Site

Dublin, Ohio, United States

Site Status

1237.25.10514 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

1237.25.10513 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Site Status

1237.25.10515 Boehringer Ingelheim Investigational Site

Easley, South Carolina, United States

Site Status

1237.25.10506 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Site Status

1237.25.10501 Boehringer Ingelheim Investigational Site

Rock Hill, South Carolina, United States

Site Status

1237.25.10508 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Site Status

1237.25.10520 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

Site Status

1237.25.10510 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

1237.25.10521 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Site Status

1237.25.32001 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1237.25.32004 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1237.25.32005 Boehringer Ingelheim Investigational Site

Eupen, , Belgium

Site Status

1237.25.32003 Boehringer Ingelheim Investigational Site

Lebbeke, , Belgium

Site Status

1237.25.32002 Boehringer Ingelheim Investigational Site

Turnhout, , Belgium

Site Status

1237.25.11508 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Site Status

1237.25.11504 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Site Status

1237.25.11501 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1237.25.11505 Boehringer Ingelheim Investigational Site

Burlington, Ontario, Canada

Site Status

1237.25.11507 Boehringer Ingelheim Investigational Site

Grimsby, Ontario, Canada

Site Status

1237.25.11510 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Site Status

1237.25.11502 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Site Status

1237.25.11506 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Site Status

1237.25.11509 Boehringer Ingelheim Investigational Site

Sherbrooke, Quebec, Canada

Site Status

1237.25.42003 Boehringer Ingelheim Investigational Site

Jindřichův Hradec, , Czechia

Site Status

1237.25.42005 Boehringer Ingelheim Investigational Site

Karlovy Vary-Drahovice, , Czechia

Site Status

1237.25.42002 Boehringer Ingelheim Investigational Site

Neratovice, , Czechia

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1237.25.42001 Boehringer Ingelheim Investigational Site

Prague, , Czechia

Site Status

1237.25.42004 Boehringer Ingelheim Investigational Site

Rokycany, , Czechia

Site Status

1237.25.45003 Boehringer Ingelheim Investigational Site

Aalborg, , Denmark

Site Status

1237.25.45002 Boehringer Ingelheim Investigational Site

Hellerup, , Denmark

Site Status

1237.25.45001 Boehringer Ingelheim Investigational Site

Odense, , Denmark

Site Status

1237.25.45004 Boehringer Ingelheim Investigational Site

Silkeborg, , Denmark

Site Status

1237.25.35802 Boehringer Ingelheim Investigational Site

Pori, , Finland

Site Status

1237.25.35801 Boehringer Ingelheim Investigational Site

Turku, , Finland

Site Status

1237.25.35803 Boehringer Ingelheim Investigational Site

Turku, , Finland

Site Status

1237.25.49504 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1237.25.49508 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1237.25.49510 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1237.25.49501 Boehringer Ingelheim Investigational Site

Großhansdorf, , Germany

Site Status

1237.25.49505 Boehringer Ingelheim Investigational Site

Halle, , Germany

Site Status

1237.25.49506 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1237.25.49515 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1237.25.49509 Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

1237.25.49514 Boehringer Ingelheim Investigational Site

Koblenz, , Germany

Site Status

1237.25.49507 Boehringer Ingelheim Investigational Site

Mainz, , Germany

Site Status

1237.25.49502 Boehringer Ingelheim Investigational Site

Neu-Isenburg, , Germany

Site Status

1237.25.49516 Boehringer Ingelheim Investigational Site

Oschersleben, , Germany

Site Status

1237.25.49511 Boehringer Ingelheim Investigational Site

Rodgau, , Germany

Site Status

1237.25.49503 Boehringer Ingelheim Investigational Site

Rosenheim, , Germany

Site Status

1237.25.49513 Boehringer Ingelheim Investigational Site

Teuchern, , Germany

Site Status

1237.25.27506 Boehringer Ingelheim Investigational Site

Bloemfontein, , South Africa

Site Status

1237.25.27501 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

Site Status

1237.25.27505 Boehringer Ingelheim Investigational Site

eMkhomazi, , South Africa

Site Status

1237.25.27504 Boehringer Ingelheim Investigational Site

Morningside, Sandton, , South Africa

Site Status

1237.25.27502 Boehringer Ingelheim Investigational Site

Parow, , South Africa

Site Status

1237.25.27503 Boehringer Ingelheim Investigational Site

Pretoria, , South Africa

Site Status

1237.25.34003 Boehringer Ingelheim Investigational Site

Alicante, , Spain

Site Status

1237.25.34007 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1237.25.34001 Boehringer Ingelheim Investigational Site

Mérida, , Spain

Site Status

1237.25.34002 Boehringer Ingelheim Investigational Site

Pozuelo de Alarcón, , Spain

Site Status

1237.25.34004 Boehringer Ingelheim Investigational Site

Vic, , Spain

Site Status

1237.25.44002 Boehringer Ingelheim Investigational Site

Bradford, , United Kingdom

Site Status

1237.25.44001 Boehringer Ingelheim Investigational Site

Chertsey, , United Kingdom

Site Status

1237.25.44004 Boehringer Ingelheim Investigational Site

Chester, , United Kingdom

Site Status

1237.25.44005 Boehringer Ingelheim Investigational Site

Chippenham, , United Kingdom

Site Status

1237.25.44003 Boehringer Ingelheim Investigational Site

Wolverhampton, , United Kingdom

Site Status

Countries

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United States Belgium Canada Czechia Denmark Finland Germany South Africa Spain United Kingdom

References

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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)

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.

Reference Type DERIVED
PMID: 27316465 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26320402 (View on PubMed)

Other Identifiers

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2013-002243-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1237.25

Identifier Type: -

Identifier Source: org_study_id