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COMPLETEDPhase 3NCT01964352

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

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 tiot...

Lead sponsor: Boehringer Ingelheim•20 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Boehringer Ingelheim

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 25, 2015Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment813

Start dateNov 2013

Last updatedNov 25, 2015

Condition

Pulmonary Disease, Chronic Obstructive

Locations shown

1237.25.10504 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado

1237.25.10507 Boehringer Ingelheim Investigational Site

Clearwater, Florida

1237.25.10517 Boehringer Ingelheim Investigational Site

Panama City, Florida

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2015Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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