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Characterization of 24-hour Lung Function Profiles of Inhaled Tiotropium + Olodaterol Fixed Dose Combination in Patients Suffering From Chronic Obstructive Pulmonary Disease

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
tiotropium + olodaterol
tiotropium
olodaterol
tiotropium
tiotropium + olodaterol
Placebo
Respimat
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:

  1. Diagnosis of chronic obstructive pulmonary disease
  2. Relatively stable airway obstruction with a post-bronchodilator FEV1< 80% of predicted normal and a post-bronchodilator FEV1/FVC <70%
  3. Male or female patients, 40 years of age or older
  4. Smoking history of more than 10 pack years
  5. Ability to perform technically acceptable pulmonary function tests and maintain records
  6. Ability to inhale medication in a competent manner from the RESPIMAT Inhaler and from a metered dose inhaler (MDI)

Exclusion criteria:

  1. significant disease other than COPD
  2. clinically relevant abnormal lab values
  3. history of asthma
  4. diagnosis of thyrotoxicosis
  5. diagnosis of paroxysmal tachycardia
  6. history of myocardial infarction
  7. unstable or life-threatening cardiac arrhythmia
  8. Hospitalization for heart failure within the past year
  9. known active tuberculosis
  10. malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
  11. history of life-threatening pulmonary obstruction
  12. history of cystic fibrosis
  13. clinically evident bronchiectasis
  14. history of significant alcohol or drug abuse
  15. history of thoracotomy with pulmonary resection
  16. oral or patch ß-adrenergics
  17. oral corticosteroid medication at unstable doses
  18. regular use daytime oxygen therapy for more than one hour per day
  19. Pulmonary rehabilitation program in the six weeks prior to the screening visit
  20. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
  21. Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA
  22. Pregnant or nursing women
  23. Women of childbearing potential not using a highly effective method of birth control
  24. Patients who have previously been randomised in this study or are currently participating in another study
  25. Patients who are unable to comply with pulmonary medication restrictions prior to randomisation

Sites / Locations

  • 1237.20.1204 Boehringer Ingelheim Investigational Site
  • 1237.20.1203 Boehringer Ingelheim Investigational Site
  • 1237.20.1201 Boehringer Ingelheim Investigational Site
  • 1237.20.1202 Boehringer Ingelheim Investigational Site
  • 1237.20.32203 Boehringer Ingelheim Investigational Site
  • 1237.20.32201 Boehringer Ingelheim Investigational Site
  • 1237.20.32204 Boehringer Ingelheim Investigational Site
  • 1237.20.02201 Boehringer Ingelheim Investigational Site
  • 1237.20.02202 Boehringer Ingelheim Investigational Site
  • 1237.20.45002 Boehringer Ingelheim Investigational Site
  • 1237.20.45003 Boehringer Ingelheim Investigational Site
  • 1237.20.45001 Boehringer Ingelheim Investigational Site
  • 1237.20.49205 Boehringer Ingelheim Investigational Site
  • 1237.20.49204 Boehringer Ingelheim Investigational Site
  • 1237.20.49203 Boehringer Ingelheim Investigational Site
  • 1237.20.49206 Boehringer Ingelheim Investigational Site
  • 1237.20.49201 Boehringer Ingelheim Investigational Site
  • 1237.20.49207 Boehringer Ingelheim Investigational Site
  • 1237.20.49202 Boehringer Ingelheim Investigational Site
  • 1237.20.36202 Boehringer Ingelheim Investigational Site
  • 1237.20.36204 Boehringer Ingelheim Investigational Site
  • 1237.20.36203 Boehringer Ingelheim Investigational Site
  • 1237.20.36201 Boehringer Ingelheim Investigational Site
  • 1237.20.36205 Boehringer Ingelheim Investigational Site
  • 1237.20.31205 Boehringer Ingelheim Investigational Site
  • 1237.20.31202 Boehringer Ingelheim Investigational Site
  • 1237.20.31201 Boehringer Ingelheim Investigational Site
  • 1237.20.31204 Boehringer Ingelheim Investigational Site
  • 1237.20.31203 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

tiotropium+olodaterol FDC low dose

tiotropium+olodaterol FDC high dose

tiotropium low dose

tiotropium high dose

olodaterol

placebo

Arm Description

tiotropium+olodaterol FDC low dose; 2 inhalations once daily (a.m. dosing)

tiotropium+olodaterol FDC high dose; 2 inhalations once daily (a.m. dosing)

tiotropium low dose; 2 inhalations once daily (a.m. dosing)

tiotropium high dose; 2 inhalations once daily (a.m. dosing)

one dose only; 2 inhalations once daily (a.m. dosing)

2 inhalations once daily (a.m. dosing)

Outcomes

Primary Outcome Measures

Forced Expiratory Volume in 1 Second (FEV1) AUC0-24h Response [L] After 6 Weeks Treatment.
Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 0 to 24 h post-dose, using the trapezoidal rule, divided by the duration (24 h) to report in litres. Mean is actually the Adjusted mean. The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.

Secondary Outcome Measures

FEV1 AUC0-12h Response [L] After 6 Weeks Treatment.
Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 0 to 12 h post-dose, using the trapezoidal rule, divided by the duration (12h) to report in litres. Mean is actually the Adjusted mean. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
FEV1 AUC12-24h Response [L] After 6 Weeks Treatment.
Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 12 to 24 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres. Mean is actually the Adjusted mean. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Trough FEV1 Response [L] After 6 Weeks Treatment.
Trough Forced Expiratory Volume in 1 second (FEV1) response after 6 weeks treatment period. The trough was defined as the mean of the 23 h and 23 h50 min measurements and Response was defined as the change from patient baseline. Mean is actually the Adjusted mean. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Peak(0-3h) FEV1 Response [L] After 6 Weeks Treatment.
Peak (0-3h) Forced Expiratory Volume in 1 second (FEV1) response. The peak was defined as the maximum value measured within the first 3 h post dosing and response was defined as the change from patient baseline. Mean is actually the Adjusted mean. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
FVC AUC0-24h Response [L] After 6 Weeks Treatment.
Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres. Mean is actually the Adjusted mean. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
FVC AUC0-12h Response [L] After 6 Weeks Treatment.
Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres. Mean is actually the Adjusted mean. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
FVC AUC12-24h Response [L] After 6 Weeks Treatment.
Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 12 to 24 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres. Mean is actually the Adjusted mean. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Trough FVC Response [L] After 6 Weeks Treatment.
Trough Forced Vital Capacity (FVC) response after 6 weeks treatment period. The trough was defined as the mean of the 23 h and 23 h50 min measurements and response was defined as the change from patient baseline. Mean is actually the Adjusted mean. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Peak (0-3h) FVC Response [L] After 6 Weeks Treatment.
Peak (0-3h) Forced Vital Capacity (FVC) responses after 6 weeks treatment. Peak was defined as the maximum value measured within the first 3 h post dosing and response was defined as the change from patient baseline. Mean is actually the Adjusted mean. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.

Full Information

First Posted
March 19, 2012
Last Updated
June 19, 2015
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT01559116
Brief Title
Characterization of 24-hour Lung Function Profiles of Inhaled Tiotropium + Olodaterol Fixed Dose Combination in Patients Suffering From Chronic Obstructive Pulmonary Disease
Official Title
Randomised, Double-blind, Placebo-controlled, 6 Treatment, 4 Period, Incomplete Cross-over Trial to Characterise the 24-hour Lung Function Profiles of Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 µg, 5/5 µg), Tiotropium (2.5 µg, 5 µg) and Olodaterol (5 µg) (Oral Inhalation, Delivered by the Respimat® Inhaler) After 6 Weeks Once Daily Treatment in Patients With Chronic Obstructive Pulmonary Disease (COPD) [VIVACITOTM]
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC, administered once daily by the RESPIMAT Inhaler after 6 weeks of treatment.

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
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
219 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tiotropium+olodaterol FDC low dose
Arm Type
Experimental
Arm Description
tiotropium+olodaterol FDC low dose; 2 inhalations once daily (a.m. dosing)
Arm Title
tiotropium+olodaterol FDC high dose
Arm Type
Experimental
Arm Description
tiotropium+olodaterol FDC high dose; 2 inhalations once daily (a.m. dosing)
Arm Title
tiotropium low dose
Arm Type
Active Comparator
Arm Description
tiotropium low dose; 2 inhalations once daily (a.m. dosing)
Arm Title
tiotropium high dose
Arm Type
Active Comparator
Arm Description
tiotropium high dose; 2 inhalations once daily (a.m. dosing)
Arm Title
olodaterol
Arm Type
Active Comparator
Arm Description
one dose only; 2 inhalations once daily (a.m. dosing)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
2 inhalations once daily (a.m. dosing)
Intervention Type
Drug
Intervention Name(s)
tiotropium + olodaterol
Intervention Description
low dose + one dose only
Intervention Type
Drug
Intervention Name(s)
tiotropium
Intervention Description
low dose
Intervention Type
Drug
Intervention Name(s)
olodaterol
Intervention Description
one dose only
Intervention Type
Drug
Intervention Name(s)
tiotropium
Intervention Description
high dose
Intervention Type
Drug
Intervention Name(s)
tiotropium + olodaterol
Intervention Description
low dose + one dose only
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo matching tiotropium+olodaterol FDC
Intervention Type
Device
Intervention Name(s)
Respimat
Intervention Description
Respimat inhaler
Primary Outcome Measure Information:
Title
Forced Expiratory Volume in 1 Second (FEV1) AUC0-24h Response [L] After 6 Weeks Treatment.
Description
Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 0 to 24 h post-dose, using the trapezoidal rule, divided by the duration (24 h) to report in litres. Mean is actually the Adjusted mean. The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Time Frame
day 1 and week 6
Secondary Outcome Measure Information:
Title
FEV1 AUC0-12h Response [L] After 6 Weeks Treatment.
Description
Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 0 to 12 h post-dose, using the trapezoidal rule, divided by the duration (12h) to report in litres. Mean is actually the Adjusted mean. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Time Frame
day 1 and week 6
Title
FEV1 AUC12-24h Response [L] After 6 Weeks Treatment.
Description
Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 12 to 24 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres. Mean is actually the Adjusted mean. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Time Frame
day 1 and week 6
Title
Trough FEV1 Response [L] After 6 Weeks Treatment.
Description
Trough Forced Expiratory Volume in 1 second (FEV1) response after 6 weeks treatment period. The trough was defined as the mean of the 23 h and 23 h50 min measurements and Response was defined as the change from patient baseline. Mean is actually the Adjusted mean. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Time Frame
day 1 and week 6
Title
Peak(0-3h) FEV1 Response [L] After 6 Weeks Treatment.
Description
Peak (0-3h) Forced Expiratory Volume in 1 second (FEV1) response. The peak was defined as the maximum value measured within the first 3 h post dosing and response was defined as the change from patient baseline. Mean is actually the Adjusted mean. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Time Frame
day 1 and week 6
Title
FVC AUC0-24h Response [L] After 6 Weeks Treatment.
Description
Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres. Mean is actually the Adjusted mean. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Time Frame
day 1 and week 6
Title
FVC AUC0-12h Response [L] After 6 Weeks Treatment.
Description
Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres. Mean is actually the Adjusted mean. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Time Frame
day 1 and week 6
Title
FVC AUC12-24h Response [L] After 6 Weeks Treatment.
Description
Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 12 to 24 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres. Mean is actually the Adjusted mean. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Time Frame
day 1 and week 6
Title
Trough FVC Response [L] After 6 Weeks Treatment.
Description
Trough Forced Vital Capacity (FVC) response after 6 weeks treatment period. The trough was defined as the mean of the 23 h and 23 h50 min measurements and response was defined as the change from patient baseline. Mean is actually the Adjusted mean. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Time Frame
day1 and week 6
Title
Peak (0-3h) FVC Response [L] After 6 Weeks Treatment.
Description
Peak (0-3h) Forced Vital Capacity (FVC) responses after 6 weeks treatment. Peak was defined as the maximum value measured within the first 3 h post dosing and response was defined as the change from patient baseline. Mean is actually the Adjusted mean. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Time Frame
day 1 and week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Diagnosis of chronic obstructive pulmonary disease Relatively stable airway obstruction with a post-bronchodilator FEV1< 80% of predicted normal and a post-bronchodilator FEV1/FVC <70% Male or female patients, 40 years of age or older Smoking history of more than 10 pack years Ability to perform technically acceptable pulmonary function tests and maintain records Ability to inhale medication in a competent manner from the RESPIMAT Inhaler and from a metered dose inhaler (MDI) Exclusion criteria: significant disease other than COPD clinically relevant abnormal lab values history of asthma diagnosis of thyrotoxicosis diagnosis of paroxysmal tachycardia history of myocardial infarction unstable or life-threatening cardiac arrhythmia Hospitalization for heart failure within the past year known active tuberculosis malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years history of life-threatening pulmonary obstruction history of cystic fibrosis clinically evident bronchiectasis history of significant alcohol or drug abuse history of thoracotomy with pulmonary resection oral or patch ß-adrenergics oral corticosteroid medication at unstable doses regular use daytime oxygen therapy for more than one hour per day Pulmonary rehabilitation program in the six weeks prior to the screening visit Investigational drug within one month or six half lives (whichever is greater) prior to screening visit Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA Pregnant or nursing women Women of childbearing potential not using a highly effective method of birth control Patients who have previously been randomised in this study or are currently participating in another study Patients who are unable to comply with pulmonary medication restrictions prior to randomisation
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
1237.20.1204 Boehringer Ingelheim Investigational Site
City
Jasper
State/Province
Alabama
Country
United States
Facility Name
1237.20.1203 Boehringer Ingelheim Investigational Site
City
Easley
State/Province
South Carolina
Country
United States
Facility Name
1237.20.1201 Boehringer Ingelheim Investigational Site
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
1237.20.1202 Boehringer Ingelheim Investigational Site
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
1237.20.32203 Boehringer Ingelheim Investigational Site
City
Genk
Country
Belgium
Facility Name
1237.20.32201 Boehringer Ingelheim Investigational Site
City
Gent
Country
Belgium
Facility Name
1237.20.32204 Boehringer Ingelheim Investigational Site
City
Jambes
Country
Belgium
Facility Name
1237.20.02201 Boehringer Ingelheim Investigational Site
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
1237.20.02202 Boehringer Ingelheim Investigational Site
City
Quebec
Country
Canada
Facility Name
1237.20.45002 Boehringer Ingelheim Investigational Site
City
Hvidovre
Country
Denmark
Facility Name
1237.20.45003 Boehringer Ingelheim Investigational Site
City
Odense C
Country
Denmark
Facility Name
1237.20.45001 Boehringer Ingelheim Investigational Site
City
Silkeborg
Country
Denmark
Facility Name
1237.20.49205 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1237.20.49204 Boehringer Ingelheim Investigational Site
City
Großhansdorf
Country
Germany
Facility Name
1237.20.49203 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
1237.20.49206 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
1237.20.49201 Boehringer Ingelheim Investigational Site
City
Mannheim
Country
Germany
Facility Name
1237.20.49207 Boehringer Ingelheim Investigational Site
City
Mönchengladbach
Country
Germany
Facility Name
1237.20.49202 Boehringer Ingelheim Investigational Site
City
Wiesbaden
Country
Germany
Facility Name
1237.20.36202 Boehringer Ingelheim Investigational Site
City
Gödöllö
Country
Hungary
Facility Name
1237.20.36204 Boehringer Ingelheim Investigational Site
City
Komarom
Country
Hungary
Facility Name
1237.20.36203 Boehringer Ingelheim Investigational Site
City
Pecs
Country
Hungary
Facility Name
1237.20.36201 Boehringer Ingelheim Investigational Site
City
Szarvas
Country
Hungary
Facility Name
1237.20.36205 Boehringer Ingelheim Investigational Site
City
Szazhalombatta
Country
Hungary
Facility Name
1237.20.31205 Boehringer Ingelheim Investigational Site
City
Almelo
Country
Netherlands
Facility Name
1237.20.31202 Boehringer Ingelheim Investigational Site
City
Breda
Country
Netherlands
Facility Name
1237.20.31201 Boehringer Ingelheim Investigational Site
City
Heerlen
Country
Netherlands
Facility Name
1237.20.31204 Boehringer Ingelheim Investigational Site
City
Hengelo
Country
Netherlands
Facility Name
1237.20.31203 Boehringer Ingelheim Investigational Site
City
Zutphen
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
25956072
Citation
Beeh KM, Westerman J, Kirsten AM, Hebert J, Gronke L, Hamilton A, Tetzlaff K, Derom E. The 24-h lung-function profile of once-daily tiotropium and olodaterol fixed-dose combination in chronic obstructive pulmonary disease. Pulm Pharmacol Ther. 2015 Jun;32:53-9. doi: 10.1016/j.pupt.2015.04.002. Epub 2015 May 6.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info

Learn more about this trial

Characterization of 24-hour Lung Function Profiles of Inhaled Tiotropium + Olodaterol Fixed Dose Combination in Patients Suffering From Chronic Obstructive Pulmonary Disease

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