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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
tiotropium
placebo
olodaterol
tiotropium
tiotropium
olodaterol
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

  • 1237.25.10504 Boehringer Ingelheim Investigational Site
  • 1237.25.10507 Boehringer Ingelheim Investigational Site
  • 1237.25.10517 Boehringer Ingelheim Investigational Site
  • 1237.25.10505 Boehringer Ingelheim Investigational Site
  • 1237.25.10516 Boehringer Ingelheim Investigational Site
  • 1237.25.10509 Boehringer Ingelheim Investigational Site
  • 1237.25.10519 Boehringer Ingelheim Investigational Site
  • 1237.25.10503 Boehringer Ingelheim Investigational Site
  • 1237.25.10518 Boehringer Ingelheim Investigational Site
  • 1237.25.10502 Boehringer Ingelheim Investigational Site
  • 1237.25.10511 Boehringer Ingelheim Investigational Site
  • 1237.25.10514 Boehringer Ingelheim Investigational Site
  • 1237.25.10513 Boehringer Ingelheim Investigational Site
  • 1237.25.10515 Boehringer Ingelheim Investigational Site
  • 1237.25.10506 Boehringer Ingelheim Investigational Site
  • 1237.25.10501 Boehringer Ingelheim Investigational Site
  • 1237.25.10508 Boehringer Ingelheim Investigational Site
  • 1237.25.10520 Boehringer Ingelheim Investigational Site
  • 1237.25.10510 Boehringer Ingelheim Investigational Site
  • 1237.25.10521 Boehringer Ingelheim Investigational Site
  • 1237.25.32004 Boehringer Ingelheim Investigational Site
  • 1237.25.32001 Boehringer Ingelheim Investigational Site
  • 1237.25.32005 Boehringer Ingelheim Investigational Site
  • 1237.25.32003 Boehringer Ingelheim Investigational Site
  • 1237.25.32002 Boehringer Ingelheim Investigational Site
  • 1237.25.11508 Boehringer Ingelheim Investigational Site
  • 1237.25.11504 Boehringer Ingelheim Investigational Site
  • 1237.25.11501 Boehringer Ingelheim Investigational Site
  • 1237.25.11505 Boehringer Ingelheim Investigational Site
  • 1237.25.11507 Boehringer Ingelheim Investigational Site
  • 1237.25.11510 Boehringer Ingelheim Investigational Site
  • 1237.25.11509 Boehringer Ingelheim Investigational Site
  • 1237.25.11502 Boehringer Ingelheim Investigational Site
  • 1237.25.11506 Boehringer Ingelheim Investigational Site
  • 1237.25.42003 Boehringer Ingelheim Investigational Site
  • 1237.25.42005 Boehringer Ingelheim Investigational Site
  • 1237.25.42002 Boehringer Ingelheim Investigational Site
  • 1237.25.42001 Boehringer Ingelheim Investigational Site
  • 1237.25.42004 Boehringer Ingelheim Investigational Site
  • 1237.25.45002 Boehringer Ingelheim Investigational Site
  • 1237.25.45001 Boehringer Ingelheim Investigational Site
  • 1237.25.45004 Boehringer Ingelheim Investigational Site
  • 1237.25.45003 Boehringer Ingelheim Investigational Site
  • 1237.25.35802 Boehringer Ingelheim Investigational Site
  • 1237.25.35801 Boehringer Ingelheim Investigational Site
  • 1237.25.35803 Boehringer Ingelheim Investigational Site
  • 1237.25.49504 Boehringer Ingelheim Investigational Site
  • 1237.25.49508 Boehringer Ingelheim Investigational Site
  • 1237.25.49510 Boehringer Ingelheim Investigational Site
  • 1237.25.49501 Boehringer Ingelheim Investigational Site
  • 1237.25.49505 Boehringer Ingelheim Investigational Site
  • 1237.25.49506 Boehringer Ingelheim Investigational Site
  • 1237.25.49515 Boehringer Ingelheim Investigational Site
  • 1237.25.49509 Boehringer Ingelheim Investigational Site
  • 1237.25.49514 Boehringer Ingelheim Investigational Site
  • 1237.25.49507 Boehringer Ingelheim Investigational Site
  • 1237.25.49502 Boehringer Ingelheim Investigational Site
  • 1237.25.49516 Boehringer Ingelheim Investigational Site
  • 1237.25.49511 Boehringer Ingelheim Investigational Site
  • 1237.25.49503 Boehringer Ingelheim Investigational Site
  • 1237.25.49513 Boehringer Ingelheim Investigational Site
  • 1237.25.27506 Boehringer Ingelheim Investigational Site
  • 1237.25.27501 Boehringer Ingelheim Investigational Site
  • 1237.25.27504 Boehringer Ingelheim Investigational Site
  • 1237.25.27502 Boehringer Ingelheim Investigational Site
  • 1237.25.27503 Boehringer Ingelheim Investigational Site
  • 1237.25.27505 Boehringer Ingelheim Investigational Site
  • 1237.25.34003 Boehringer Ingelheim Investigational Site
  • 1237.25.34007 Boehringer Ingelheim Investigational Site
  • 1237.25.34001 Boehringer Ingelheim Investigational Site
  • 1237.25.34002 Boehringer Ingelheim Investigational Site
  • 1237.25.34004 Boehringer Ingelheim Investigational Site
  • 1237.25.44002 Boehringer Ingelheim Investigational Site
  • 1237.25.44001 Boehringer Ingelheim Investigational Site
  • 1237.25.44004 Boehringer Ingelheim Investigational Site
  • 1237.25.44005 Boehringer Ingelheim Investigational Site
  • 1237.25.44003 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
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.

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
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.
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
October 23, 2015
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT01964352
Brief Title
Tiotropium + Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 1)
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
October 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
813 (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)
tiotropium
Intervention Description
fixed dose combination
Intervention Type
Drug
Intervention Name(s)
placebo
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)
tiotropium
Intervention Type
Drug
Intervention Name(s)
olodaterol
Intervention Description
fixed dose combination
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
Description
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.
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
Description
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.
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
1237.25.10504 Boehringer Ingelheim Investigational Site
City
Wheat Ridge
State/Province
Colorado
Country
United States
Facility Name
1237.25.10507 Boehringer Ingelheim Investigational Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
1237.25.10517 Boehringer Ingelheim Investigational Site
City
Panama City
State/Province
Florida
Country
United States
Facility Name
1237.25.10505 Boehringer Ingelheim Investigational Site
City
Coeur d'Alene
State/Province
Idaho
Country
United States
Facility Name
1237.25.10516 Boehringer Ingelheim Investigational Site
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
1237.25.10509 Boehringer Ingelheim Investigational Site
City
Livonia
State/Province
Michigan
Country
United States
Facility Name
1237.25.10519 Boehringer Ingelheim Investigational Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
1237.25.10503 Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
1237.25.10518 Boehringer Ingelheim Investigational Site
City
Columbia
State/Province
Ohio
Country
United States
Facility Name
1237.25.10502 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
1237.25.10511 Boehringer Ingelheim Investigational Site
City
Dublin
State/Province
Ohio
Country
United States
Facility Name
1237.25.10514 Boehringer Ingelheim Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
1237.25.10513 Boehringer Ingelheim Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
1237.25.10515 Boehringer Ingelheim Investigational Site
City
Easley
State/Province
South Carolina
Country
United States
Facility Name
1237.25.10506 Boehringer Ingelheim Investigational Site
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
1237.25.10501 Boehringer Ingelheim Investigational Site
City
Rock Hill
State/Province
South Carolina
Country
United States
Facility Name
1237.25.10508 Boehringer Ingelheim Investigational Site
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
1237.25.10520 Boehringer Ingelheim Investigational Site
City
Killeen
State/Province
Texas
Country
United States
Facility Name
1237.25.10510 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
1237.25.10521 Boehringer Ingelheim Investigational Site
City
Spokane
State/Province
Washington
Country
United States
Facility Name
1237.25.32004 Boehringer Ingelheim Investigational Site
City
Brussels
Country
Belgium
Facility Name
1237.25.32001 Boehringer Ingelheim Investigational Site
City
Brussel
Country
Belgium
Facility Name
1237.25.32005 Boehringer Ingelheim Investigational Site
City
Eupen
Country
Belgium
Facility Name
1237.25.32003 Boehringer Ingelheim Investigational Site
City
Lebbeke
Country
Belgium
Facility Name
1237.25.32002 Boehringer Ingelheim Investigational Site
City
Turnhout
Country
Belgium
Facility Name
1237.25.11508 Boehringer Ingelheim Investigational Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
1237.25.11504 Boehringer Ingelheim Investigational Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
1237.25.11501 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1237.25.11505 Boehringer Ingelheim Investigational Site
City
Burlington
State/Province
Ontario
Country
Canada
Facility Name
1237.25.11507 Boehringer Ingelheim Investigational Site
City
Grimsby
State/Province
Ontario
Country
Canada
Facility Name
1237.25.11510 Boehringer Ingelheim Investigational Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
1237.25.11509 Boehringer Ingelheim Investigational Site
City
Sherbrooke,
State/Province
Quebec
Country
Canada
Facility Name
1237.25.11502 Boehringer Ingelheim Investigational Site
City
Quebec
Country
Canada
Facility Name
1237.25.11506 Boehringer Ingelheim Investigational Site
City
Quebec
Country
Canada
Facility Name
1237.25.42003 Boehringer Ingelheim Investigational Site
City
Jindrichuv Hradec
Country
Czech Republic
Facility Name
1237.25.42005 Boehringer Ingelheim Investigational Site
City
Karlovy Vary-Drahovice
Country
Czech Republic
Facility Name
1237.25.42002 Boehringer Ingelheim Investigational Site
City
Neratovice
Country
Czech Republic
Facility Name
1237.25.42001 Boehringer Ingelheim Investigational Site
City
Prague
Country
Czech Republic
Facility Name
1237.25.42004 Boehringer Ingelheim Investigational Site
City
Rokycany
Country
Czech Republic
Facility Name
1237.25.45002 Boehringer Ingelheim Investigational Site
City
Hellerup
Country
Denmark
Facility Name
1237.25.45001 Boehringer Ingelheim Investigational Site
City
Odense
Country
Denmark
Facility Name
1237.25.45004 Boehringer Ingelheim Investigational Site
City
Silkeborg
Country
Denmark
Facility Name
1237.25.45003 Boehringer Ingelheim Investigational Site
City
Ålborg
Country
Denmark
Facility Name
1237.25.35802 Boehringer Ingelheim Investigational Site
City
Pori
Country
Finland
Facility Name
1237.25.35801 Boehringer Ingelheim Investigational Site
City
Turku
Country
Finland
Facility Name
1237.25.35803 Boehringer Ingelheim Investigational Site
City
Turku
Country
Finland
Facility Name
1237.25.49504 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1237.25.49508 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1237.25.49510 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1237.25.49501 Boehringer Ingelheim Investigational Site
City
Großhansdorf
Country
Germany
Facility Name
1237.25.49505 Boehringer Ingelheim Investigational Site
City
Halle/Saale
Country
Germany
Facility Name
1237.25.49506 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
1237.25.49515 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
1237.25.49509 Boehringer Ingelheim Investigational Site
City
Hannover
Country
Germany
Facility Name
1237.25.49514 Boehringer Ingelheim Investigational Site
City
Koblenz
Country
Germany
Facility Name
1237.25.49507 Boehringer Ingelheim Investigational Site
City
Mainz
Country
Germany
Facility Name
1237.25.49502 Boehringer Ingelheim Investigational Site
City
Neu-Isenburg
Country
Germany
Facility Name
1237.25.49516 Boehringer Ingelheim Investigational Site
City
Oschersleben
Country
Germany
Facility Name
1237.25.49511 Boehringer Ingelheim Investigational Site
City
Rodgau
Country
Germany
Facility Name
1237.25.49503 Boehringer Ingelheim Investigational Site
City
Rosenheim
Country
Germany
Facility Name
1237.25.49513 Boehringer Ingelheim Investigational Site
City
Teuchern
Country
Germany
Facility Name
1237.25.27506 Boehringer Ingelheim Investigational Site
City
Bloemfontein
Country
South Africa
Facility Name
1237.25.27501 Boehringer Ingelheim Investigational Site
City
Cape Town
Country
South Africa
Facility Name
1237.25.27504 Boehringer Ingelheim Investigational Site
City
Morningside, Sandton
Country
South Africa
Facility Name
1237.25.27502 Boehringer Ingelheim Investigational Site
City
Parow
Country
South Africa
Facility Name
1237.25.27503 Boehringer Ingelheim Investigational Site
City
Pretoria
Country
South Africa
Facility Name
1237.25.27505 Boehringer Ingelheim Investigational Site
City
Umkomaas
Country
South Africa
Facility Name
1237.25.34003 Boehringer Ingelheim Investigational Site
City
Alicante
Country
Spain
Facility Name
1237.25.34007 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1237.25.34001 Boehringer Ingelheim Investigational Site
City
Mérida
Country
Spain
Facility Name
1237.25.34002 Boehringer Ingelheim Investigational Site
City
Pozuelo de Alarcón
Country
Spain
Facility Name
1237.25.34004 Boehringer Ingelheim Investigational Site
City
Vic
Country
Spain
Facility Name
1237.25.44002 Boehringer Ingelheim Investigational Site
City
Bradford
Country
United Kingdom
Facility Name
1237.25.44001 Boehringer Ingelheim Investigational Site
City
Chertsey
Country
United Kingdom
Facility Name
1237.25.44004 Boehringer Ingelheim Investigational Site
City
Chester
Country
United Kingdom
Facility Name
1237.25.44005 Boehringer Ingelheim Investigational Site
City
Chippenham
Country
United Kingdom
Facility Name
1237.25.44003 Boehringer Ingelheim Investigational Site
City
Wolverhampton
Country
United Kingdom

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

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