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Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)

NCT ID: NCT02006732

Last Updated: 2016-01-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

809 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.

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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

Once daily 2 puffs solution for inhalation Respimat

Group Type EXPERIMENTAL

olodaterol

Intervention Type DRUG

fixed dose combination

tiotropium

Intervention Type DRUG

fixed dose combination

tiotropium + olodaterol high dose

Once daily 2 puffs solution for inhalation Respimat

Group Type EXPERIMENTAL

olodaterol

Intervention Type DRUG

fixed dose combination

tiotropium

Intervention Type DRUG

fixed dose combination

tiotropium

Once daily 2 puffs solution for inhalation Respimat

Group Type ACTIVE_COMPARATOR

tiotropium

Intervention Type DRUG

fixed dose combination

placebo

Once daily 2 puffs solution for inhalation Respimat

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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olodaterol

fixed dose combination

Intervention Type DRUG

tiotropium

fixed dose combination

Intervention Type DRUG

placebo

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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1237.26.10620 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

Site Status

1237.26.10618 Boehringer Ingelheim Investigational Site

Stamford, Connecticut, United States

Site Status

1237.26.10619 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Site Status

1237.26.10614 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Site Status

1237.26.10616 Boehringer Ingelheim Investigational Site

Duluth, Georgia, United States

Site Status

1237.26.10613 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Site Status

1237.26.10615 Boehringer Ingelheim Investigational Site

Greensboro, North Carolina, United States

Site Status

1237.26.10603 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Site Status

1237.26.10621 Boehringer Ingelheim Investigational Site

Dayton, Ohio, United States

Site Status

1237.26.10612 Boehringer Ingelheim Investigational Site

Toledo, Ohio, United States

Site Status

1237.26.10605 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

1237.26.10606 Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

Site Status

1237.26.10610 Boehringer Ingelheim Investigational Site

East Providence, Rhode Island, United States

Site Status

1237.26.10607 Boehringer Ingelheim Investigational Site

Gaffney, South Carolina, United States

Site Status

1237.26.10617 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Site Status

1237.26.10608 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Site Status

1237.26.10604 Boehringer Ingelheim Investigational Site

Union, South Carolina, United States

Site Status

1237.26.10609 Boehringer Ingelheim Investigational Site

Boerne, Texas, United States

Site Status

1237.26.10602 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

1237.26.10601 Boehringer Ingelheim Investigational Site

Morgantown, West Virginia, United States

Site Status

1237.26.61004 Boehringer Ingelheim Investigational Site

Concord, New South Wales, Australia

Site Status

1237.26.61002 Boehringer Ingelheim Investigational Site

Daw Park, South Australia, Australia

Site Status

1237.26.61003 Boehringer Ingelheim Investigational Site

Toorak Gardens, South Australia, Australia

Site Status

1237.26.61007 Boehringer Ingelheim Investigational Site

Woodville, South Australia, Australia

Site Status

1237.26.61005 Boehringer Ingelheim Investigational Site

Murdoch, Western Australia, Australia

Site Status

1237.26.61001 Boehringer Ingelheim Investigational Site

Nedlands, Western Australia, Australia

Site Status

1237.26.43004 Boehringer Ingelheim Investigational Site

Feldbach, , Austria

Site Status

1237.26.43002 Boehringer Ingelheim Investigational Site

Grieskirchen, , Austria

Site Status

1237.26.43003 Boehringer Ingelheim Investigational Site

Linz, , Austria

Site Status

1237.26.43006 Boehringer Ingelheim Investigational Site

Linz, , Austria

Site Status

1237.26.43001 Boehringer Ingelheim Investigational Site

Thalheim bei Wels, , Austria

Site Status

1237.26.11605 Boehringer Ingelheim Investigational Site

Moncton, New Brunswick, Canada

Site Status

1237.26.11609 Boehringer Ingelheim Investigational Site

Courtice, Ontario, Canada

Site Status

1237.26.11608 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Site Status

1237.26.11606 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1237.26.11607 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1237.26.11601 Boehringer Ingelheim Investigational Site

Windsor, Ontario, Canada

Site Status

1237.26.11611 Boehringer Ingelheim Investigational Site

Mirabel, Quebec, Canada

Site Status

1237.26.11602 Boehringer Ingelheim Investigational Site

Point Claire, Quebec, Canada

Site Status

1237.26.11603 Boehringer Ingelheim Investigational Site

Sherbrooke, Quebec, Canada

Site Status

1237.26.49610 Boehringer Ingelheim Investigational Site

Bamberg, , Germany

Site Status

1237.26.49611 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1237.26.49616 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1237.26.49609 Boehringer Ingelheim Investigational Site

Bochum, , Germany

Site Status

1237.26.49607 Boehringer Ingelheim Investigational Site

Dresden, , Germany

Site Status

1237.26.49612 Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

Site Status

1237.26.49615 Boehringer Ingelheim Investigational Site

Halberstadt, , Germany

Site Status

1237.26.49606 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1237.26.49608 Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

1237.26.49603 Boehringer Ingelheim Investigational Site

Hettstedt, , Germany

Site Status

1237.26.49604 Boehringer Ingelheim Investigational Site

Leipzig, , Germany

Site Status

1237.26.49605 Boehringer Ingelheim Investigational Site

Leipzig, , Germany

Site Status

1237.26.49601 Boehringer Ingelheim Investigational Site

Lübeck, , Germany

Site Status

1237.26.49602 Boehringer Ingelheim Investigational Site

Rüdersdorf, , Germany

Site Status

1237.26.49614 Boehringer Ingelheim Investigational Site

Schwerin, , Germany

Site Status

1237.26.49613 Boehringer Ingelheim Investigational Site

Wiesloch, , Germany

Site Status

1237.26.30005 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1237.26.30002 Boehringer Ingelheim Investigational Site

Heraklion, , Greece

Site Status

1237.26.30001 Boehringer Ingelheim Investigational Site

Nafplion, , Greece

Site Status

1237.26.30004 Boehringer Ingelheim Investigational Site

Serres, , Greece

Site Status

1237.26.30003 Boehringer Ingelheim Investigational Site

Thessaloniki, , Greece

Site Status

1237.26.64001 Boehringer Ingelheim Investigational Site

Greenlane East Auckland NZ, , New Zealand

Site Status

1237.26.47003 Boehringer Ingelheim Investigational Site

Hamar, , Norway

Site Status

1237.26.47001 Boehringer Ingelheim Investigational Site

Hønefoss, , Norway

Site Status

1237.26.47002 Boehringer Ingelheim Investigational Site

Kløfta, , Norway

Site Status

1237.26.47004 Boehringer Ingelheim Investigational Site

Lierskogen, , Norway

Site Status

1237.26.42103 Boehringer Ingelheim Investigational Site

Bardejov, , Slovakia

Site Status

1237.26.42104 Boehringer Ingelheim Investigational Site

Humenné, , Slovakia

Site Status

1237.26.42102 Boehringer Ingelheim Investigational Site

Spišská Nová Ves, , Slovakia

Site Status

1237.26.42101 Boehringer Ingelheim Investigational Site

Vyšné Hágy, , Slovakia

Site Status

1237.26.27601 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

Site Status

1237.26.27602 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

Site Status

1237.26.27604 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

Site Status

1237.26.27605 Boehringer Ingelheim Investigational Site

Durban, , South Africa

Site Status

1237.26.46004 Boehringer Ingelheim Investigational Site

Höllviken, , Sweden

Site Status

1237.26.46001 Boehringer Ingelheim Investigational Site

Lund, , Sweden

Site Status

1237.26.46002 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1237.26.46003 Boehringer Ingelheim Investigational Site

Uddevalla, , Sweden

Site Status

Countries

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United States Australia Austria Canada Germany Greece New Zealand Norway Slovakia South Africa Sweden

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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2013-002264-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1237.26

Identifier Type: -

Identifier Source: org_study_id

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