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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
olodaterol
tiotropium
placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • 1237.26.10620 Boehringer Ingelheim Investigational Site
  • 1237.26.10618 Boehringer Ingelheim Investigational Site
  • 1237.26.10619 Boehringer Ingelheim Investigational Site
  • 1237.26.10614 Boehringer Ingelheim Investigational Site
  • 1237.26.10616 Boehringer Ingelheim Investigational Site
  • 1237.26.10613 Boehringer Ingelheim Investigational Site
  • 1237.26.10615 Boehringer Ingelheim Investigational Site
  • 1237.26.10603 Boehringer Ingelheim Investigational Site
  • 1237.26.10621 Boehringer Ingelheim Investigational Site
  • 1237.26.10612 Boehringer Ingelheim Investigational Site
  • 1237.26.10605 Boehringer Ingelheim Investigational Site
  • 1237.26.10606 Boehringer Ingelheim Investigational Site
  • 1237.26.10610 Boehringer Ingelheim Investigational Site
  • 1237.26.10607 Boehringer Ingelheim Investigational Site
  • 1237.26.10617 Boehringer Ingelheim Investigational Site
  • 1237.26.10608 Boehringer Ingelheim Investigational Site
  • 1237.26.10604 Boehringer Ingelheim Investigational Site
  • 1237.26.10609 Boehringer Ingelheim Investigational Site
  • 1237.26.10602 Boehringer Ingelheim Investigational Site
  • 1237.26.10601 Boehringer Ingelheim Investigational Site
  • 1237.26.61004 Boehringer Ingelheim Investigational Site
  • 1237.26.61002 Boehringer Ingelheim Investigational Site
  • 1237.26.61003 Boehringer Ingelheim Investigational Site
  • 1237.26.61007 Boehringer Ingelheim Investigational Site
  • 1237.26.61005 Boehringer Ingelheim Investigational Site
  • 1237.26.61001 Boehringer Ingelheim Investigational Site
  • 1237.26.43004 Boehringer Ingelheim Investigational Site
  • 1237.26.43002 Boehringer Ingelheim Investigational Site
  • 1237.26.43003 Boehringer Ingelheim Investigational Site
  • 1237.26.43006 Boehringer Ingelheim Investigational Site
  • 1237.26.43001 Boehringer Ingelheim Investigational Site
  • 1237.26.11605 Boehringer Ingelheim Investigational Site
  • 1237.26.11609 Boehringer Ingelheim Investigational Site
  • 1237.26.11608 Boehringer Ingelheim Investigational Site
  • 1237.26.11606 Boehringer Ingelheim Investigational Site
  • 1237.26.11607 Boehringer Ingelheim Investigational Site
  • 1237.26.11601 Boehringer Ingelheim Investigational Site
  • 1237.26.11611 Boehringer Ingelheim Investigational Site
  • 1237.26.11602 Boehringer Ingelheim Investigational Site
  • 1237.26.11603 Boehringer Ingelheim Investigational Site
  • 1237.26.49610 Boehringer Ingelheim Investigational Site
  • 1237.26.49611 Boehringer Ingelheim Investigational Site
  • 1237.26.49616 Boehringer Ingelheim Investigational Site
  • 1237.26.49609 Boehringer Ingelheim Investigational Site
  • 1237.26.49607 Boehringer Ingelheim Investigational Site
  • 1237.26.49612 Boehringer Ingelheim Investigational Site
  • 1237.26.49615 Boehringer Ingelheim Investigational Site
  • 1237.26.49606 Boehringer Ingelheim Investigational Site
  • 1237.26.49608 Boehringer Ingelheim Investigational Site
  • 1237.26.49603 Boehringer Ingelheim Investigational Site
  • 1237.26.49604 Boehringer Ingelheim Investigational Site
  • 1237.26.49605 Boehringer Ingelheim Investigational Site
  • 1237.26.49601 Boehringer Ingelheim Investigational Site
  • 1237.26.49602 Boehringer Ingelheim Investigational Site
  • 1237.26.49614 Boehringer Ingelheim Investigational Site
  • 1237.26.49613 Boehringer Ingelheim Investigational Site
  • 1237.26.30005 Boehringer Ingelheim Investigational Site
  • 1237.26.30002 Boehringer Ingelheim Investigational Site
  • 1237.26.30001 Boehringer Ingelheim Investigational Site
  • 1237.26.30004 Boehringer Ingelheim Investigational Site
  • 1237.26.30003 Boehringer Ingelheim Investigational Site
  • 1237.26.64001 Boehringer Ingelheim Investigational Site
  • 1237.26.47003 Boehringer Ingelheim Investigational Site
  • 1237.26.47001 Boehringer Ingelheim Investigational Site
  • 1237.26.47002 Boehringer Ingelheim Investigational Site
  • 1237.26.47004 Boehringer Ingelheim Investigational Site
  • 1237.26.42103 Boehringer Ingelheim Investigational Site
  • 1237.26.42104 Boehringer Ingelheim Investigational Site
  • 1237.26.42102 Boehringer Ingelheim Investigational Site
  • 1237.26.42101 Boehringer Ingelheim Investigational Site
  • 1237.26.27601 Boehringer Ingelheim Investigational Site
  • 1237.26.27602 Boehringer Ingelheim Investigational Site
  • 1237.26.27604 Boehringer Ingelheim Investigational Site
  • 1237.26.27605 Boehringer Ingelheim Investigational Site
  • 1237.26.46004 Boehringer Ingelheim Investigational Site
  • 1237.26.46001 Boehringer Ingelheim Investigational Site
  • 1237.26.46002 Boehringer Ingelheim Investigational Site
  • 1237.26.46003 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

tiotropium + olodaterol low dose

tiotropium + olodaterol high dose

tiotropium

placebo

Arm Description

Once daily 2 puffs solution for inhalation Respimat

Once daily 2 puffs solution for inhalation Respimat

Once daily 2 puffs solution for inhalation Respimat

Once daily 2 puffs solution for inhalation Respimat

Outcomes

Primary Outcome Measures

FEV1 AUC0-3h Response
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.
Trough FEV1 Response (Change From Baseline)
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.
St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Data From This Individual Study
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.
St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352
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.

Secondary Outcome Measures

Trough Forced Vital Capacity (FVC) Response (Change From Baseline)
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.
TDI Focal Score Based on Data From This Individual Study
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.
TDI Focal Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352
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.
FVC AUC0-3h Response (Change From Baseline)
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.

Full Information

First Posted
October 14, 2013
Last Updated
December 10, 2015
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT02006732
Brief Title
Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
809 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tiotropium + olodaterol low dose
Arm Type
Experimental
Arm Description
Once daily 2 puffs solution for inhalation Respimat
Arm Title
tiotropium + olodaterol high dose
Arm Type
Experimental
Arm Description
Once daily 2 puffs solution for inhalation Respimat
Arm Title
tiotropium
Arm Type
Active Comparator
Arm Description
Once daily 2 puffs solution for inhalation Respimat
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Once daily 2 puffs solution for inhalation Respimat
Intervention Type
Drug
Intervention Name(s)
olodaterol
Intervention Description
fixed dose combination
Intervention Type
Drug
Intervention Name(s)
tiotropium
Intervention Description
fixed dose combination
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
FEV1 AUC0-3h Response
Description
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.
Time Frame
baseline and 12 weeks
Title
Trough FEV1 Response (Change From Baseline)
Description
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.
Time Frame
baseline and 12 weeks
Title
St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Data From This Individual Study
Description
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.
Time Frame
12 weeks treatment
Title
St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352
Description
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.
Time Frame
12 weeks treatment
Secondary Outcome Measure Information:
Title
Trough Forced Vital Capacity (FVC) Response (Change From Baseline)
Description
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.
Time Frame
baseline and 12 weeks
Title
TDI Focal Score Based on Data From This Individual Study
Description
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.
Time Frame
12 weeks
Title
TDI Focal Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352
Description
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.
Time Frame
12 weeks
Title
FVC AUC0-3h Response (Change From Baseline)
Description
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.
Time Frame
baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1237.26.10620 Boehringer Ingelheim Investigational Site
City
Jasper
State/Province
Alabama
Country
United States
Facility Name
1237.26.10618 Boehringer Ingelheim Investigational Site
City
Stamford
State/Province
Connecticut
Country
United States
Facility Name
1237.26.10619 Boehringer Ingelheim Investigational Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
1237.26.10614 Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
1237.26.10616 Boehringer Ingelheim Investigational Site
City
Duluth
State/Province
Georgia
Country
United States
Facility Name
1237.26.10613 Boehringer Ingelheim Investigational Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
1237.26.10615 Boehringer Ingelheim Investigational Site
City
Greensboro
State/Province
North Carolina
Country
United States
Facility Name
1237.26.10603 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
1237.26.10621 Boehringer Ingelheim Investigational Site
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
1237.26.10612 Boehringer Ingelheim Investigational Site
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
1237.26.10605 Boehringer Ingelheim Investigational Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
1237.26.10606 Boehringer Ingelheim Investigational Site
City
Medford
State/Province
Oregon
Country
United States
Facility Name
1237.26.10610 Boehringer Ingelheim Investigational Site
City
East Providence
State/Province
Rhode Island
Country
United States
Facility Name
1237.26.10607 Boehringer Ingelheim Investigational Site
City
Gaffney
State/Province
South Carolina
Country
United States
Facility Name
1237.26.10617 Boehringer Ingelheim Investigational Site
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
1237.26.10608 Boehringer Ingelheim Investigational Site
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
1237.26.10604 Boehringer Ingelheim Investigational Site
City
Union
State/Province
South Carolina
Country
United States
Facility Name
1237.26.10609 Boehringer Ingelheim Investigational Site
City
Boerne
State/Province
Texas
Country
United States
Facility Name
1237.26.10602 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1237.26.10601 Boehringer Ingelheim Investigational Site
City
Morgantown
State/Province
West Virginia
Country
United States
Facility Name
1237.26.61004 Boehringer Ingelheim Investigational Site
City
Concord
State/Province
New South Wales
Country
Australia
Facility Name
1237.26.61002 Boehringer Ingelheim Investigational Site
City
Daw Park
State/Province
South Australia
Country
Australia
Facility Name
1237.26.61003 Boehringer Ingelheim Investigational Site
City
Toorak Gardens
State/Province
South Australia
Country
Australia
Facility Name
1237.26.61007 Boehringer Ingelheim Investigational Site
City
Woodville
State/Province
South Australia
Country
Australia
Facility Name
1237.26.61005 Boehringer Ingelheim Investigational Site
City
Murdoch
State/Province
Western Australia
Country
Australia
Facility Name
1237.26.61001 Boehringer Ingelheim Investigational Site
City
Nedlands
State/Province
Western Australia
Country
Australia
Facility Name
1237.26.43004 Boehringer Ingelheim Investigational Site
City
Feldbach
Country
Austria
Facility Name
1237.26.43002 Boehringer Ingelheim Investigational Site
City
Grieskirchen
Country
Austria
Facility Name
1237.26.43003 Boehringer Ingelheim Investigational Site
City
Linz
Country
Austria
Facility Name
1237.26.43006 Boehringer Ingelheim Investigational Site
City
Linz
Country
Austria
Facility Name
1237.26.43001 Boehringer Ingelheim Investigational Site
City
Thalheim bei Wels
Country
Austria
Facility Name
1237.26.11605 Boehringer Ingelheim Investigational Site
City
Moncton
State/Province
New Brunswick
Country
Canada
Facility Name
1237.26.11609 Boehringer Ingelheim Investigational Site
City
Courtice
State/Province
Ontario
Country
Canada
Facility Name
1237.26.11608 Boehringer Ingelheim Investigational Site
City
Sarnia
State/Province
Ontario
Country
Canada
Facility Name
1237.26.11606 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1237.26.11607 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1237.26.11601 Boehringer Ingelheim Investigational Site
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
1237.26.11611 Boehringer Ingelheim Investigational Site
City
Mirabel
State/Province
Quebec
Country
Canada
Facility Name
1237.26.11602 Boehringer Ingelheim Investigational Site
City
Point Claire
State/Province
Quebec
Country
Canada
Facility Name
1237.26.11603 Boehringer Ingelheim Investigational Site
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
1237.26.49610 Boehringer Ingelheim Investigational Site
City
Bamberg
Country
Germany
Facility Name
1237.26.49611 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1237.26.49616 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1237.26.49609 Boehringer Ingelheim Investigational Site
City
Bochum
Country
Germany
Facility Name
1237.26.49607 Boehringer Ingelheim Investigational Site
City
Dresden
Country
Germany
Facility Name
1237.26.49612 Boehringer Ingelheim Investigational Site
City
Frankfurt
Country
Germany
Facility Name
1237.26.49615 Boehringer Ingelheim Investigational Site
City
Halberstadt
Country
Germany
Facility Name
1237.26.49606 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
1237.26.49608 Boehringer Ingelheim Investigational Site
City
Hannover
Country
Germany
Facility Name
1237.26.49603 Boehringer Ingelheim Investigational Site
City
Hettstedt
Country
Germany
Facility Name
1237.26.49604 Boehringer Ingelheim Investigational Site
City
Leipzig
Country
Germany
Facility Name
1237.26.49605 Boehringer Ingelheim Investigational Site
City
Leipzig
Country
Germany
Facility Name
1237.26.49601 Boehringer Ingelheim Investigational Site
City
Lübeck
Country
Germany
Facility Name
1237.26.49602 Boehringer Ingelheim Investigational Site
City
Rüdersdorf
Country
Germany
Facility Name
1237.26.49614 Boehringer Ingelheim Investigational Site
City
Schwerin
Country
Germany
Facility Name
1237.26.49613 Boehringer Ingelheim Investigational Site
City
Wiesloch
Country
Germany
Facility Name
1237.26.30005 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1237.26.30002 Boehringer Ingelheim Investigational Site
City
Heraklion
Country
Greece
Facility Name
1237.26.30001 Boehringer Ingelheim Investigational Site
City
Nafplio
Country
Greece
Facility Name
1237.26.30004 Boehringer Ingelheim Investigational Site
City
Serres
Country
Greece
Facility Name
1237.26.30003 Boehringer Ingelheim Investigational Site
City
Thessaloniki
Country
Greece
Facility Name
1237.26.64001 Boehringer Ingelheim Investigational Site
City
Greenlane East Auckland NZ
Country
New Zealand
Facility Name
1237.26.47003 Boehringer Ingelheim Investigational Site
City
Hamar
Country
Norway
Facility Name
1237.26.47001 Boehringer Ingelheim Investigational Site
City
Hønefoss
Country
Norway
Facility Name
1237.26.47002 Boehringer Ingelheim Investigational Site
City
Kløfta
Country
Norway
Facility Name
1237.26.47004 Boehringer Ingelheim Investigational Site
City
Lierskogen
Country
Norway
Facility Name
1237.26.42103 Boehringer Ingelheim Investigational Site
City
Bardejov
Country
Slovakia
Facility Name
1237.26.42104 Boehringer Ingelheim Investigational Site
City
Humenne
Country
Slovakia
Facility Name
1237.26.42102 Boehringer Ingelheim Investigational Site
City
Spisska Nova Ves
Country
Slovakia
Facility Name
1237.26.42101 Boehringer Ingelheim Investigational Site
City
Vysne Hagy
Country
Slovakia
Facility Name
1237.26.27601 Boehringer Ingelheim Investigational Site
City
Cape Town
Country
South Africa
Facility Name
1237.26.27602 Boehringer Ingelheim Investigational Site
City
Cape Town
Country
South Africa
Facility Name
1237.26.27604 Boehringer Ingelheim Investigational Site
City
Cape Town
Country
South Africa
Facility Name
1237.26.27605 Boehringer Ingelheim Investigational Site
City
Durban
Country
South Africa
Facility Name
1237.26.46004 Boehringer Ingelheim Investigational Site
City
Höllviken
Country
Sweden
Facility Name
1237.26.46001 Boehringer Ingelheim Investigational Site
City
Lund
Country
Sweden
Facility Name
1237.26.46002 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
1237.26.46003 Boehringer Ingelheim Investigational Site
City
Uddevalla
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
32671684
Citation
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.
Results Reference
derived
PubMed Identifier
32462607
Citation
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.
Results Reference
derived
PubMed Identifier
27316465
Citation
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.
Results Reference
derived
PubMed Identifier
26320402
Citation
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.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info

Learn more about this trial

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

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