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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002974-20 | EudraCT Number |
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The primary objective of the present study is to evaluate the effect of tiotropium + olodaterol fixed dose combination (FDC) compared to tiotropium monotherapy on the intensity of breathlessness during the 3min constant speed shuttle test (CSST).
A secondary objective is to explore the relationship between reductions in breathlessness during the 3min CSST and reductions in breathlessness during activities of everyday living as measured by the dyspnea domain of the Chronic Respiratory Questionnaire (CRQ) following bronchodilator therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiotropium + Olodaterol | Experimental | Patients will receive tiotropium 5mcg + olodaterol 5mcg in a fixed dose combination once daily. |
|
| Tiotropium | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium | Drug | fixed dose combination once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Intensity of Breathlessness Measured Using the Modified Borg Scale at the End of the 3 Minute (Min) Constant Speed Shuttle Test After 6 Weeks of Treatment. | At 3 min or end of exercise (if 3 min not achieved), patients were asked to estimate the intensity of breathing discomfort that they were experiencing by matching their subjective estimate to descriptive phrases that best described the intensity of each sensation using the Modified Borg Scale (MBS-S). The modified Borg scale is 10-point subjective scoring system, in which a patient rates effort of exertion while performing a particular activity. The scale is 0 to 10, the higher the score, the greater the perceived difficulty. Measure type is actually Adjusted Mean Change from Baseline. | Baseline and week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline After 6 Weeks of Treatment for Inspiratory Capacity Measured Prior to Exercise | Inspiratory Capacity (IC) is a standard measurement for the assessment of lung function. IC measurements were performed prior to the 3min Constant Speed Shuttle Test (CSST) (at rest). Measure type is actually Adjusted Mean Change from Baseline. | Baseline and week 6 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genk - PRAC Janssens, E. | Genk | 3600 | Belgium | |||
| Hasselt - PRAC Aumann, J-L |
All patients were screened for eligibility to participate in the trial. Patients attended specialist sites which then ensured that all patients met all inclusion/exclusion criteria. Patients were not to be randomized to trial treatment if any specific entry criteria were violated.
This was a randomised, double-blind, active-controlled, 2-period crossover, Phase IV study to evaluate the effects of once daily administration of orally inhaled tiotropium + olodaterol fixed dose combination compared with tiotropium on the intensity of breathlessness in patients with Chronic Obstructive Pulmonary Disease (COPD).
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| ID | Title | Description |
|---|---|---|
| FG000 | (Tiotropium 5 Microgram (μg))/(Tiotropium + Olodaterol 5/5 μg) | Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium (Tio) inhalation solution (2.5 μg per actuation) once a day, in the morning for a period of 6 weeks in period 1 followed by a 3 week washout period. In period 2, patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium + Olodaterol (Tio+Olo) fixed dose combination (FDC) inhalation solution (2.5/2.5 μg per actuation) once a day, in the morning for a period of 6 weeks. |
| FG001 | (Tiotropium + Olodaterol 5/5 μg)/(Tiotropium 5 μg) | Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium + Olodaterol (Tio+Olo) fixed dose combination (FDC) inhalation solution (2.5/2.5 μg per actuation) once a day, in the morning for a period of 6 weeks in period 1 followed by a 3 week washout period. In period 2, patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium (Tio) inhalation solution (2.5 μg per actuation) once a day, in the morning for a period of 6 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
|
| ||||||||||||||||||
| Washout Period |
| |||||||||||||||||||
| Treatment Period 2 |
|
Treated Set (TS): This patient set was nested within the randomized set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Subjects | This patient set was nested within the randomized set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The age data are presented by years. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Intensity of Breathlessness Measured Using the Modified Borg Scale at the End of the 3 Minute (Min) Constant Speed Shuttle Test After 6 Weeks of Treatment. | At 3 min or end of exercise (if 3 min not achieved), patients were asked to estimate the intensity of breathing discomfort that they were experiencing by matching their subjective estimate to descriptive phrases that best described the intensity of each sensation using the Modified Borg Scale (MBS-S). The modified Borg scale is 10-point subjective scoring system, in which a patient rates effort of exertion while performing a particular activity. The scale is 0 to 10, the higher the score, the greater the perceived difficulty. Measure type is actually Adjusted Mean Change from Baseline. | Full analysis set (FAS): This patient set was nested within the treated set (TS) and included patients who had baseline measurement and at least one post-baseline measurement for the primary endpoint. FAS including participants with available data for change from baseline in intensity of breathlessness after 6 weeks of treatment. | Posted | Least Squares Mean | Standard Error | Unit on Scale | Baseline and week 6 |
From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tiotropium 5 Microgram (μg) | Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium (Tio) inhalation solution (2.5 μg per actuation) once a day, in the morning for a period of 6 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral upper respiratory tract infection | Infections and infestations | 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 21, 2017 | Aug 13, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 15, 2016 | Aug 13, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Not provided
| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| C549647 | olodaterol |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
Not provided
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| Olodaterol |
| Drug |
fixed dose combination once daily |
|
| Tiotropium | Drug |
|
| Change From Baseline After 6 Weeks of Treatment for Inspiratory Capacity Measured at the End of Exercise | Inspiratory Capacity (IC) is a standard measurement for the assessment of lung function. IC measurements were performed at the end of the 3min Constant Speed Shuttle Test (CSST). Measure type is actually Adjusted Mean Change from Baseline. | Baseline and week 6 |
| Change From Baseline After 6 Weeks of Treatment for 1 Hour Post-dose Forced Expiratory Volume | Forced Expiratory Volume in 1st second (FEV1) is a standard measurement for the assessment of lung function. The best of 3 efforts was defined as the highest FEV1, each obtained on any of 3 manoeuvres meeting the American Thoracic Society (ATS) criteria (to a maximum of 5 attempts). Measure type is actually Adjusted Mean Change from Baseline. | Baseline and week 6 |
| Change From Baseline After 6 Weeks of Treatment for 1 Hour Post-dose Forced Vital Capacity | Forced Vital Capacity (FVC) is a standard measurement for the assessment of lung function. The best of 3 efforts was defined as the highest FVC, each obtained on any of 3 manoeuvres meeting the American Thoracic Society (ATS) criteria (to a maximum of 5 attempts). Measure type is actually Adjusted Mean Change from Baseline. | Baseline and week 6 |
| Change From Baseline After 6 Weeks of Treatment for Intensity of Breathlessness (MBS-S) at 1, 2 and 2.5 Minute (Min) During the 3 Min Constant Speed Shuttle Test | At 1, 2 and 2.5 min during exercise, patients were asked to estimate the intensity of breathing discomfort that they were experiencing by matching their subjective estimate to descriptive phrases that best described the intensity of each sensation using the Modified Borg Scale (MBS-S). At 3 min or end of exercise (if 3 min not achieved), patients were asked to estimate the intensity of breathing discomfort that they were experiencing by matching their subjective estimate to descriptive phrases that best described the intensity of each sensation using the Modified Borg Scale (MBS-S). The modified Borg scale is 10-point subjective scoring system, in which a patient rates effort of exertion while performing a particular activity. The scale is 0 to 10, the higher the score, the greater the perceived difficulty. Measure type is actually Adjusted Mean Change from Baseline. | Baseline and week 6 |
| Change From Baseline After 6 Weeks of Treatment for Chronic Respiratory Questionnaire - Self Administered Individualized (CRQ-SAI) Dyspnoea Domain Score | CRQ-SAI refers to the CRQ-Self-administered individualized format as it contains a dyspnea domain that is individualized to each patient. This version was derived from the original CRQ tool & therefore, is scored on 7-point Likert-type scale (1: maximum impairment to 7: no impairment) for each 4 domains covering: dyspnea, fatigue, emotional function & mastery. Dyspnea items may be selected from list of 26 suggested items or written in by the patients. The patients are asked to select up to 5 activities associated with breathlessness that they perform frequently and are most important to them. The scores for each question of each domain were added together and divided by the number of questions answered in each domain. The higher scores indicate better health-related quality of life in the respective domain. Measure type is actually Adjusted Mean Change from Baseline. | Baseline and week 6 |
| Change From Baseline After 6 Weeks of Treatment for Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS) Dyspnoea Domain Score | CRQ-SAS was questionnaire to assess patients' perception of COPD and measures the impact of COPD on their life. This version was derived from the original CRQ tool & therefore, is scored on 7-point Likert-type scale (1: maximum impairment to 7: no impairment) for each 4 domains covering: dyspnea, fatigue, emotional function & mastery. The CRQ-SAS refers to the CRQ-Self-administered standardized format & contains 20 questions. The first part of the questionnaire contains 5 standardized dyspnea questions and the patients must indicate how much shortness of breath they have experienced while performing each of these 5 activities. The scores for each question of each domain were added together and divided by the number of questions answered in each domain. The higher scores indicate better health-related quality of life in the respective domain. Measure type is actually Adjusted Mean Change from Baseline. | Baseline and week 6 |
| Hasselt |
| 3500 |
| Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| McMaster Univ. Medical Centre | Hamilton | Ontario | L8N 3Z5 | Canada |
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| McGill University Health Centre (MUHC) | Montreal | Quebec | H4A 3J1 | Canada |
| IUCPQ (Laval University) | Québec | G1V 4G5 | Canada |
| Klinische Forschung Berlin GbR | Berlin | 10787 | Germany |
| IKF Pneumologie GmbH & Co. KG | Frankfurt am Main | 60596 | Germany |
| Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH | Großhansdorf | 22927 | Germany |
| Catharina Ziekenhuis | Eindhoven | 5623 EJ | Netherlands |
| Zuyderland Medisch Centrum | Heerlen | 6419 PC | Netherlands |
| Gelre Ziekenhuis Zutphen | Zutphen | 7207 AE | Netherlands |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
TS
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | The sex data are presented by count of participants. | TS | Count of Participants | Participants |
|
| Race (NIH/OMB) | The race data are presented by count of participants. Ethnicity was not captured in this trial. | TS | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Tiotropium 5 Microgram (μg) | Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium (Tio) inhalation solution (2.5 μg per actuation) once a day, in the morning for a period of 6 weeks. |
| OG001 | Tiotropium + Olodaterol 5/5 μg | Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium + Olodaterol (Tio+Olo) fixed dose combination (FDC) inhalation solution (2.5/2.5 μg per actuation) once a day, in the morning for a period of 6 weeks. |
|
|
|
| Secondary | Change From Baseline After 6 Weeks of Treatment for Inspiratory Capacity Measured Prior to Exercise | Inspiratory Capacity (IC) is a standard measurement for the assessment of lung function. IC measurements were performed prior to the 3min Constant Speed Shuttle Test (CSST) (at rest). Measure type is actually Adjusted Mean Change from Baseline. | FAS including participants with available data for change from baseline for inspiratory capacity measured prior to exercise after 6 weeks of treatment. | Posted | Least Squares Mean | Standard Error | Litre (L) | Baseline and week 6 |
|
|
|
|
| Secondary | Change From Baseline After 6 Weeks of Treatment for Inspiratory Capacity Measured at the End of Exercise | Inspiratory Capacity (IC) is a standard measurement for the assessment of lung function. IC measurements were performed at the end of the 3min Constant Speed Shuttle Test (CSST). Measure type is actually Adjusted Mean Change from Baseline. | FAS including participants with available data for change from baseline for inspiratory capacity measured end of exercise after 6 weeks of treatment. | Posted | Least Squares Mean | Standard Error | Litre (L) | Baseline and week 6 |
|
|
|
|
| Secondary | Change From Baseline After 6 Weeks of Treatment for 1 Hour Post-dose Forced Expiratory Volume | Forced Expiratory Volume in 1st second (FEV1) is a standard measurement for the assessment of lung function. The best of 3 efforts was defined as the highest FEV1, each obtained on any of 3 manoeuvres meeting the American Thoracic Society (ATS) criteria (to a maximum of 5 attempts). Measure type is actually Adjusted Mean Change from Baseline. | FAS including participants with available data for change from baseline for FEV1 after 6 weeks of treatment. | Posted | Least Squares Mean | Standard Error | Litre (L) | Baseline and week 6 |
|
|
|
|
| Secondary | Change From Baseline After 6 Weeks of Treatment for 1 Hour Post-dose Forced Vital Capacity | Forced Vital Capacity (FVC) is a standard measurement for the assessment of lung function. The best of 3 efforts was defined as the highest FVC, each obtained on any of 3 manoeuvres meeting the American Thoracic Society (ATS) criteria (to a maximum of 5 attempts). Measure type is actually Adjusted Mean Change from Baseline. | FAS including participants with available data for change from baseline for FVC after 6 weeks of treatment. | Posted | Least Squares Mean | Standard Error | Litre (L) | Baseline and week 6 |
|
|
|
|
| Secondary | Change From Baseline After 6 Weeks of Treatment for Intensity of Breathlessness (MBS-S) at 1, 2 and 2.5 Minute (Min) During the 3 Min Constant Speed Shuttle Test | At 1, 2 and 2.5 min during exercise, patients were asked to estimate the intensity of breathing discomfort that they were experiencing by matching their subjective estimate to descriptive phrases that best described the intensity of each sensation using the Modified Borg Scale (MBS-S). At 3 min or end of exercise (if 3 min not achieved), patients were asked to estimate the intensity of breathing discomfort that they were experiencing by matching their subjective estimate to descriptive phrases that best described the intensity of each sensation using the Modified Borg Scale (MBS-S). The modified Borg scale is 10-point subjective scoring system, in which a patient rates effort of exertion while performing a particular activity. The scale is 0 to 10, the higher the score, the greater the perceived difficulty. Measure type is actually Adjusted Mean Change from Baseline. | FAS including participants with available data for MBS-S after 6 weeks of treatment. | Posted | Least Squares Mean | Standard Error | Unit on Scale | Baseline and week 6 |
|
|
|
|
| Secondary | Change From Baseline After 6 Weeks of Treatment for Chronic Respiratory Questionnaire - Self Administered Individualized (CRQ-SAI) Dyspnoea Domain Score | CRQ-SAI refers to the CRQ-Self-administered individualized format as it contains a dyspnea domain that is individualized to each patient. This version was derived from the original CRQ tool & therefore, is scored on 7-point Likert-type scale (1: maximum impairment to 7: no impairment) for each 4 domains covering: dyspnea, fatigue, emotional function & mastery. Dyspnea items may be selected from list of 26 suggested items or written in by the patients. The patients are asked to select up to 5 activities associated with breathlessness that they perform frequently and are most important to them. The scores for each question of each domain were added together and divided by the number of questions answered in each domain. The higher scores indicate better health-related quality of life in the respective domain. Measure type is actually Adjusted Mean Change from Baseline. | FAS including participants with available data for change from baseline for CRQ-SAI questionnaire after 6 weeks of treatment. | Posted | Least Squares Mean | Standard Error | Unit on Scale | Baseline and week 6 |
|
|
|
|
| Secondary | Change From Baseline After 6 Weeks of Treatment for Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS) Dyspnoea Domain Score | CRQ-SAS was questionnaire to assess patients' perception of COPD and measures the impact of COPD on their life. This version was derived from the original CRQ tool & therefore, is scored on 7-point Likert-type scale (1: maximum impairment to 7: no impairment) for each 4 domains covering: dyspnea, fatigue, emotional function & mastery. The CRQ-SAS refers to the CRQ-Self-administered standardized format & contains 20 questions. The first part of the questionnaire contains 5 standardized dyspnea questions and the patients must indicate how much shortness of breath they have experienced while performing each of these 5 activities. The scores for each question of each domain were added together and divided by the number of questions answered in each domain. The higher scores indicate better health-related quality of life in the respective domain. Measure type is actually Adjusted Mean Change from Baseline. | FAS including participants with available data for change from baseline for CRQ-SAS questionnaire after 6 weeks of treatment. | Posted | Least Squares Mean | Standard Error | Unit on Scale | Baseline and week 6 |
|
|
|
|
| 0 |
| 100 |
| 1 |
| 100 |
| 21 |
| 100 |
| EG001 | Tiotropium + Olodaterol 5/5 μg | Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium + Olodaterol (Tio+Olo) fixed dose combination (FDC) inhalation solution (2.5/2.5 μg per actuation) once a day, in the morning for a period of 6 weeks. | 0 | 105 | 5 | 105 | 31 | 105 |
| EG002 | Total Subjects | This patient set was nested within the randomized set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication. | 0 | 106 | 6 | 106 | 44 | 106 |
| Pneumonia influenzal | Infections and infestations | 20.0 | Systematic Assessment |
|
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | 20.0 | Systematic Assessment |
|
| Coma | Nervous system disorders | 20.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | 20.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | 20.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| 2.5 min |
|
| Superiority |
| 2 min, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation. | Mixed Effect Model Repeated Measures | Kenward-Roger approximation of denominator was used for degrees of freedom. | 0.0267 | Mean Difference (Final Values) | -0.240 | Standard Error of the Mean | 0.107 | 2-Sided | 95 | -0.452 | -0.028 | Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium). | Superiority |
| 2.5 min, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation. | Mixed Effect Model Repeated Measures | Kenward-Roger approximation of denominator was used for degrees of freedom. | 0.0258 | Mean Difference (Final Values) | -0.318 | Standard Error of the Mean | 0.140 | 2-Sided | 95 | -0.596 | -0.039 | Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium). | Superiority |
| Superiority |
| Superiority |