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

October 23, 2015 updated by: Boehringer Ingelheim

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

813

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tiotropium + olodaterol low dose
Once daily 2 puffs solution for inhalation Respimat
Drug: tiotropium
Drug: tiotropium
fixed dose combination
Drug: olodaterol
fixed dose combination
Experimental: tiotropium + olodaterol high dose
Once daily 2 puffs solution for inhalation Respimat
Drug: tiotropium
Drug: tiotropium
fixed dose combination
Drug: olodaterol
fixed dose combination
Active Comparator: tiotropium
Once daily 2 puffs solution for inhalation Respimat
Drug: tiotropium
Drug: tiotropium
fixed dose combination
Placebo Comparator: placebo
Once daily 2 puffs solution for inhalation Respimat
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FEV1 AUC0-3h Response
Time Frame: baseline and 12 weeks
Forced expiratory volume in one second (FEV1) Area under the curve (AUC) 0-3h was calculated as the area under the FEV1-time curve from 0 to 3h post-dose using the trapezoidal rule, divided by the duration (3h) to report in litres. FEV1 AUC0-3h response was defined as FEV1 AUC0-3h minus baseline FEV1. The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
baseline and 12 weeks
Trough FEV1 Response (Change From Baseline)
Time Frame: baseline and 12 weeks
Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FEV1 measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FEV1 response was defines as trough FEV1 minus baseline FEV1. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
baseline and 12 weeks
St. George's Respiratory Questionnaire (SGRQ) Total Score
Time Frame: 12 weeks treatment

This endpoint was evaluated based on the data from this individual trial and also based on the data from the combined dataset from this trial and the replicate study NCT02006732. The results for the combined dataset are included in the disclosure for NCT02006732 as specified in the analysis plan. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).

The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
12 weeks treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Forced Vital Capacity (FVC) Response (Change From Baseline)
Time Frame: baseline and 12 weeks
Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FVC measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FVC response was defined as trough FVC minus baseline FVC. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
baseline and 12 weeks
TDI Focal Score
Time Frame: 12 weeks

This endpoint was evaluated based on the data from this individual trial and also based on the data from the combined dataset from this trial and the replicate study NCT02006732. The results for the combined dataset are included in the disclosure for NCT02006732 as specified in the analysis plan. Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9).

The adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
12 weeks
FVC AUC0-3h Response (Change From Baseline)
Time Frame: baseline and 12 weeks
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

October 14, 2013

First Submitted That Met QC Criteria

October 14, 2013

First Posted (Estimate)

October 17, 2013

Study Record Updates

Last Update Posted (Estimate)

November 25, 2015

Last Update Submitted That Met QC Criteria

October 23, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1237.25
  • 2013-002243-29 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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