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

December 10, 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
809

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia
        • 1237.26.61004 Boehringer Ingelheim Investigational Site
    • South Australia
      • Daw Park, South Australia, Australia
        • 1237.26.61002 Boehringer Ingelheim Investigational Site
      • Toorak Gardens, South Australia, Australia
        • 1237.26.61003 Boehringer Ingelheim Investigational Site
      • Woodville, South Australia, Australia
        • 1237.26.61007 Boehringer Ingelheim Investigational Site
    • Western Australia
      • Murdoch, Western Australia, Australia
        • 1237.26.61005 Boehringer Ingelheim Investigational Site
      • Nedlands, Western Australia, Australia
        • 1237.26.61001 Boehringer Ingelheim Investigational Site
  • Austria
      • Feldbach, Austria
        • 1237.26.43004 Boehringer Ingelheim Investigational Site
      • Grieskirchen, Austria
        • 1237.26.43002 Boehringer Ingelheim Investigational Site
      • Linz, Austria
        • 1237.26.43003 Boehringer Ingelheim Investigational Site
      • Linz, Austria
        • 1237.26.43006 Boehringer Ingelheim Investigational Site
      • Thalheim bei Wels, Austria
        • 1237.26.43001 Boehringer Ingelheim Investigational Site
  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada
        • 1237.26.11605 Boehringer Ingelheim Investigational Site
    • Ontario
      • Courtice, Ontario, Canada
        • 1237.26.11609 Boehringer Ingelheim Investigational Site
      • Sarnia, Ontario, Canada
        • 1237.26.11608 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1237.26.11606 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1237.26.11607 Boehringer Ingelheim Investigational Site
      • Windsor, Ontario, Canada
        • 1237.26.11601 Boehringer Ingelheim Investigational Site
    • Quebec
      • Mirabel, Quebec, Canada
        • 1237.26.11611 Boehringer Ingelheim Investigational Site
      • Point Claire, Quebec, Canada
        • 1237.26.11602 Boehringer Ingelheim Investigational Site
      • Sherbrooke, Quebec, Canada
        • 1237.26.11603 Boehringer Ingelheim Investigational Site
  • Germany
      • Bamberg, Germany
        • 1237.26.49610 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1237.26.49611 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1237.26.49616 Boehringer Ingelheim Investigational Site
      • Bochum, Germany
        • 1237.26.49609 Boehringer Ingelheim Investigational Site
      • Dresden, Germany
        • 1237.26.49607 Boehringer Ingelheim Investigational Site
      • Frankfurt, Germany
        • 1237.26.49612 Boehringer Ingelheim Investigational Site
      • Halberstadt, Germany
        • 1237.26.49615 Boehringer Ingelheim Investigational Site
      • Hamburg, Germany
        • 1237.26.49606 Boehringer Ingelheim Investigational Site
      • Hannover, Germany
        • 1237.26.49608 Boehringer Ingelheim Investigational Site
      • Hettstedt, Germany
        • 1237.26.49603 Boehringer Ingelheim Investigational Site
      • Leipzig, Germany
        • 1237.26.49604 Boehringer Ingelheim Investigational Site
      • Leipzig, Germany
        • 1237.26.49605 Boehringer Ingelheim Investigational Site
      • Lübeck, Germany
        • 1237.26.49601 Boehringer Ingelheim Investigational Site
      • Rüdersdorf, Germany
        • 1237.26.49602 Boehringer Ingelheim Investigational Site
      • Schwerin, Germany
        • 1237.26.49614 Boehringer Ingelheim Investigational Site
      • Wiesloch, Germany
        • 1237.26.49613 Boehringer Ingelheim Investigational Site
  • Greece
      • Athens, Greece
        • 1237.26.30005 Boehringer Ingelheim Investigational Site
      • Heraklion, Greece
        • 1237.26.30002 Boehringer Ingelheim Investigational Site
      • Nafplio, Greece
        • 1237.26.30001 Boehringer Ingelheim Investigational Site
      • Serres, Greece
        • 1237.26.30004 Boehringer Ingelheim Investigational Site
      • Thessaloniki, Greece
        • 1237.26.30003 Boehringer Ingelheim Investigational Site
  • New Zealand
      • Greenlane East Auckland NZ, New Zealand
        • 1237.26.64001 Boehringer Ingelheim Investigational Site
  • Norway
      • Hamar, Norway
        • 1237.26.47003 Boehringer Ingelheim Investigational Site
      • Hønefoss, Norway
        • 1237.26.47001 Boehringer Ingelheim Investigational Site
      • Kløfta, Norway
        • 1237.26.47002 Boehringer Ingelheim Investigational Site
      • Lierskogen, Norway
        • 1237.26.47004 Boehringer Ingelheim Investigational Site
  • Slovakia
      • Bardejov, Slovakia
        • 1237.26.42103 Boehringer Ingelheim Investigational Site
      • Humenne, Slovakia
        • 1237.26.42104 Boehringer Ingelheim Investigational Site
      • Spisska Nova Ves, Slovakia
        • 1237.26.42102 Boehringer Ingelheim Investigational Site
      • Vysne Hagy, Slovakia
        • 1237.26.42101 Boehringer Ingelheim Investigational Site
  • South Africa
      • Cape Town, South Africa
        • 1237.26.27601 Boehringer Ingelheim Investigational Site
      • Cape Town, South Africa
        • 1237.26.27602 Boehringer Ingelheim Investigational Site
      • Cape Town, South Africa
        • 1237.26.27604 Boehringer Ingelheim Investigational Site
      • Durban, South Africa
        • 1237.26.27605 Boehringer Ingelheim Investigational Site
  • Sweden
      • Höllviken, Sweden
        • 1237.26.46004 Boehringer Ingelheim Investigational Site
      • Lund, Sweden
        • 1237.26.46001 Boehringer Ingelheim Investigational Site
      • Stockholm, Sweden
        • 1237.26.46002 Boehringer Ingelheim Investigational Site
      • Uddevalla, Sweden
        • 1237.26.46003 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Jasper, Alabama, United States
        • 1237.26.10620 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Stamford, Connecticut, United States
        • 1237.26.10618 Boehringer Ingelheim Investigational Site
    • Florida
      • Clearwater, Florida, United States
        • 1237.26.10619 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, United States
        • 1237.26.10614 Boehringer Ingelheim Investigational Site
    • Georgia
      • Duluth, Georgia, United States
        • 1237.26.10616 Boehringer Ingelheim Investigational Site
    • Missouri
      • St. Louis, Missouri, United States
        • 1237.26.10613 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Greensboro, North Carolina, United States
        • 1237.26.10615 Boehringer Ingelheim Investigational Site
    • Ohio
      • Columbus, Ohio, United States
        • 1237.26.10603 Boehringer Ingelheim Investigational Site
      • Dayton, Ohio, United States
        • 1237.26.10621 Boehringer Ingelheim Investigational Site
      • Toledo, Ohio, United States
        • 1237.26.10612 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • 1237.26.10605 Boehringer Ingelheim Investigational Site
    • Oregon
      • Medford, Oregon, United States
        • 1237.26.10606 Boehringer Ingelheim Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, United States
        • 1237.26.10610 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Gaffney, South Carolina, United States
        • 1237.26.10607 Boehringer Ingelheim Investigational Site
      • Greenville, South Carolina, United States
        • 1237.26.10617 Boehringer Ingelheim Investigational Site
      • Spartanburg, South Carolina, United States
        • 1237.26.10608 Boehringer Ingelheim Investigational Site
      • Union, South Carolina, United States
        • 1237.26.10604 Boehringer Ingelheim Investigational Site
    • Texas
      • Boerne, Texas, United States
        • 1237.26.10609 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1237.26.10602 Boehringer Ingelheim Investigational Site
    • West Virginia
      • Morgantown, West Virginia, United States
        • 1237.26.10601 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: tiotropium + olodaterol low dose
Once daily 2 puffs solution for inhalation Respimat
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
fixed dose combination
Drug: olodaterol
fixed dose combination
Active Comparator: tiotropium
Once daily 2 puffs solution for inhalation Respimat
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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 Based on Data From This Individual Study
Time Frame: 12 weeks treatment

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
St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352
Time Frame: 12 weeks treatment

This endpoint was evaluated after combining the data from this and the replicate study NCT01964352 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
TDI Focal Score Based on Data From This Individual Study
Time Frame: 12 weeks

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
TDI Focal Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352
Time Frame: 12 weeks

This endpoint was evaluated after combining the data from this and the replicate study NCT01964352 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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1237.26
  • 2013-002264-24 (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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