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Tiotropium + Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 1) | Clinical Trials | Clareo Health

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

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)

NCT01964352•Boehringer Ingelheim

View on ClinicalTrials.gov

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

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (77)

1237.25.10504 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

1237.25.10507 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

1237.25.10517 Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

1237.25.10505 Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, United States

1237.25.10516 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

1237.25.10509 Boehringer Ingelheim Investigational Site

Livonia, Michigan, United States

1237.25.10519 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

1237.25.10503 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

1237.25.10518 Boehringer Ingelheim Investigational Site

Columbia, Ohio, United States

1237.25.10502 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Key Dates

Start Date

November 1, 2013

Primary Completion Date

October 1, 2014

Completion Date

November 1, 2014

Last Updated

November 25, 2015

Enrollment

813

ACTUAL participants

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

tiotropium

DRUG

placebo

DRUG

olodaterol

DRUG

tiotropium

DRUG

tiotropium

DRUG

olodaterol

DRUG

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

NCT06831994

Asthma BronchialeBreast Neoplasms+11 more

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RECRUITING

The London COPD Exacerbation Cohort

NCT02755974

Pulmonary Disease, Chronic Obstructive

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ACTIVE_NOT_RECRUITING

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: March 29, 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.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

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