Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002671-18 | EudraCT Number | EudraCT |
Not provided
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The primary objectives of the study are to explore the effect of treatment with orally inhaled tiotropium + olodaterol fixed dose combination with and without exercise training, and tiotropium comparing to placebo, on top of behavioural modification in improving exercise capacity in patients with COPD
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | patient will receive placebo once daily, 2 puffs in the morning |
|
| tiotropium + olodaterol high dose with BM | Experimental | patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily, 2 puffs in the morning |
|
| tiotropium | Active Comparator | patient will receive tiotropium 5 mcg once daily, 2 puffs in the morning |
|
| tiotropium + olodaterol with exercise training and BM | Experimental | patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily, 2 puffs in the morning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo to tiotropium + olodaterol | Drug | comparator |
| |
| tiotropium+olodaterol |
| Measure | Description | Time Frame |
|---|---|---|
| Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks | Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of predicted maximum oxygen consumption (VO2 peak) after 8 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then an analysis of covariance (ANCOVA) was fitted to the log10-transformed data and the least square means (LSMean) and standard error (SE) were obtained. To present the results in a way easier for interpretation, the least square mean from the ANCOVA fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate to obtain the geometric mean and the corresponding SE was transformed using delta method to get the corresponding SE of the geometric mean. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Daily Walking Time Measured by the Activity Monitor in the Week Prior to Week 12 | Average daily walking time measured by the activity monitor in the week prior to Week 12. | Week 12 |
| Average Daily Walking Intensity Measured by the Activity Monitor in the Week Prior to 12 Weeks of Treatment |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | San Diego | California | United States | |||
| Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27075841 | Derived | Troosters T, Bourbeau J, Maltais F, Leidy N, Erzen D, De Sousa D, Korducki L, Hamilton A. Enhancing exercise tolerance and physical activity in COPD with combined pharmacological and non-pharmacological interventions: PHYSACTO randomised, placebo-controlled study design. BMJ Open. 2016 Apr 13;6(4):e010106. doi: 10.1136/bmjopen-2015-010106. | |
| 27044576 |
Not provided
Not provided
An exploratory, randomised, partially double-blinded, placebo-controlled, parallel group trial to explore the effects of tiotropium + olodaterol fixed dose combination (FDC) or tiotropium, supervised exercise training and behaviour modification on exercise capacity and physical activity in patients with Chronic Obstructive Pulmonary Disease (COPD)
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo With Behavioural Modification (BM) | Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks. |
| FG001 | Tiotropium (Tio) 5 Micro-grams (μg) With BM |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
tiotropium 5 mcg once daily |
|
| tiotropium +olodaterol | Drug | olodaterol 5 mcg once daily fixed dose combination |
|
| tiotropium | Drug | tiotropium 5 mcg once daily fixed dose combination |
|
Average daily walking intensity measured by the activity monitor in the week prior to 12 weeks of treatment. The Movement Intensity (MI) is derived from the acceleration signals. Since seismic sensors measure gravitational acceleration (g) in static situations, the acceleration signal is expressed relative to g (1g = 9.81m/s2). To calculate movement intensity (MI) the gravitational acceleration in static situations was removed and the rotation vector of the three accelerometer signals was calculated. The MI gives an indication of the power of movements. |
| Week 12 |
| Perceived Difficulties as Evaluated With Functional Performance Inventory-Short Form (FPI-SF) Total Score at Week 12 | Perceived difficulties as evaluated with FPI-SF. FPI-SF self-report questionnaire has 6 domains: Body care(5 items), Household maintenance(8 items), Physical exercise(5 items), Recreation(5 items), Spiritual activities(4 items) and Social interaction(5 items) with five possible answers on each item: Do with no difficulty - 3, Do with some difficulty - 2, Do with great difficulty - 1, don't do because of health reasons - 0, and don't do because choose not to - 0. Domain scores are expressed as mean values, with at least 6 non-missing items required for the household maintenance domain and at least 3 non-missing items for the other domains. Total score is the mean across the six domains. So total and domain scores range from 0 to 3, with higher scores indicating higher levels of functional activity within and across domains. Respondents engaged in many activities with no difficulty will score high on the FPI, while those who perform few activities with much difficulty will score low. | Week 12 |
| Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 12 Weeks | Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of maximum oxygen consumption (VO2 peak) after 12 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then the ANCOVA was fitted to the log10-transformed data and the least square means and SE were obtained. To present the results in a way easier for interpretation, the least square mean from the ANCOVA fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate to obtain the geometric mean and the corresponding SE was transformed using delta method to get the corresponding SE of the geometric mean. | Week 12 |
| One Hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 8 Weeks of Treatment | One hour, Post-dose Forced Expiratory Volume in One Second (FEV1) after 8 weeks of treatment. | Week 8 |
| One Hour, Post-dose Forced Vital Capacity (FVC) After 8 Weeks of Treatment | One hour, Post-dose Forced Vital Capacity (FVC) after 8 weeks of treatment. | Week 8 |
| Resting Inspiratory Capacity (IC) Measured at 1.5 Hours Post Dose After 8 Weeks of Treatment | Resting inspiratory capacity (IC) measured at 1.5 hours post dose after 8 weeks of treatment. | Week 8 |
| Torrance |
| California |
| United States |
| Boehringer Ingelheim Investigational Site | Hartford | Connecticut | United States |
| Boehringer Ingelheim Investigational Site | Daw Park | South Australia | Australia |
| Boehringer Ingelheim Investigational Site | Glen Osmond | South Australia | Australia |
| Boehringer Ingelheim Investigational Site | Salzburg | Austria |
| Boehringer Ingelheim Investigational Site | Genk | Belgium |
| Boehringer Ingelheim Investigational Site | Hasselt | Belgium |
| Boehringer Ingelheim Investigational Site | Leuven | Belgium |
| Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada |
| Boehringer Ingelheim Investigational Site | Ste-Foy | Quebec | Canada |
| Boehringer Ingelheim Investigational Site | Saskatoon | Saskatchewan | Canada |
| Boehringer Ingelheim Investigational Site | Kolding | Denmark |
| Boehringer Ingelheim Investigational Site | København NV | Denmark |
| Boehringer Ingelheim Investigational Site | Odense | Denmark |
| Boehringer Ingelheim Investigational Site | Berlin | Germany |
| Boehringer Ingelheim Investigational Site | Bochum | Germany |
| Boehringer Ingelheim Investigational Site | Frankfurt | Germany |
| Boehringer Ingelheim Investigational Site | Großhansdorf | Germany |
| Boehringer Ingelheim Investigational Site | Heidelberg | Germany |
| Boehringer Ingelheim Investigational Site | Leverkusen | Germany |
| Boehringer Ingelheim Investigational Site | Solingen | Germany |
| Boehringer Ingelheim Investigational Site | Teuchern | Germany |
| Boehringer Ingelheim Investigational Site | Tübingen | Germany |
| Boehringer Ingelheim Investigational Site | Greenlane East Auckland NZ | New Zealand |
| Boehringer Ingelheim Investigational Site | Gdansk | Poland |
| Boehringer Ingelheim Investigational Site | Lodz | Poland |
| Boehringer Ingelheim Investigational Site | Starachowice | Poland |
| Boehringer Ingelheim Investigational Site | Coimbra | Portugal |
| Boehringer Ingelheim Investigational Site | Lisbon | Portugal |
| Boehringer Ingelheim Investigational Site | Porto | Portugal |
| Boehringer Ingelheim Investigational Site | Leicester | United Kingdom |
| Boehringer Ingelheim Investigational Site | Norwich | United Kingdom |
| Boehringer Ingelheim Investigational Site | Sheffield | United Kingdom |
| Bourbeau J, Lavoie KL, Sedeno M, De Sousa D, Erzen D, Hamilton A, Maltais F, Troosters T, Leidy N. Behaviour-change intervention in a multicentre, randomised, placebo-controlled COPD study: methodological considerations and implementation. BMJ Open. 2016 Apr 4;6(4):e010109. doi: 10.1136/bmjopen-2015-010109. |
Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks. |
| FG002 | Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM | Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks. |
| FG003 | Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM | Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated set (TS): This patient set included all patients of the Randomised set (All patients who signed informed consent form and were also randomised, regardless whether the patient was treated with study medication or not.) who were dispensed study medication and were documented to have taken any dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo With Behavioural Modification (BM) | Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks. |
| BG001 | Tiotropium (Tio) 5 Micro-grams (μg) With BM | Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks. |
| BG002 | Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM | Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks. |
| BG003 | Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM | Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
|
| 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 | Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks | Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of predicted maximum oxygen consumption (VO2 peak) after 8 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then an analysis of covariance (ANCOVA) was fitted to the log10-transformed data and the least square means (LSMean) and standard error (SE) were obtained. To present the results in a way easier for interpretation, the least square mean from the ANCOVA fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate to obtain the geometric mean and the corresponding SE was transformed using delta method to get the corresponding SE of the geometric mean. | Full analysis set (FAS): This patient set included all patients in the Treated set (TS) who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included. | Posted | Geometric Mean | Standard Error | Second | Week 8 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Daily Walking Time Measured by the Activity Monitor in the Week Prior to Week 12 | Average daily walking time measured by the activity monitor in the week prior to Week 12. | Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included. | Posted | Least Squares Mean | Standard Error | Second | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Daily Walking Intensity Measured by the Activity Monitor in the Week Prior to 12 Weeks of Treatment | Average daily walking intensity measured by the activity monitor in the week prior to 12 weeks of treatment. The Movement Intensity (MI) is derived from the acceleration signals. Since seismic sensors measure gravitational acceleration (g) in static situations, the acceleration signal is expressed relative to g (1g = 9.81m/s2). To calculate movement intensity (MI) the gravitational acceleration in static situations was removed and the rotation vector of the three accelerometer signals was calculated. The MI gives an indication of the power of movements. | Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included. | Posted | Least Squares Mean | Standard Error | Multiple of 9.8*(meters / (second^2)) | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Perceived Difficulties as Evaluated With Functional Performance Inventory-Short Form (FPI-SF) Total Score at Week 12 | Perceived difficulties as evaluated with FPI-SF. FPI-SF self-report questionnaire has 6 domains: Body care(5 items), Household maintenance(8 items), Physical exercise(5 items), Recreation(5 items), Spiritual activities(4 items) and Social interaction(5 items) with five possible answers on each item: Do with no difficulty - 3, Do with some difficulty - 2, Do with great difficulty - 1, don't do because of health reasons - 0, and don't do because choose not to - 0. Domain scores are expressed as mean values, with at least 6 non-missing items required for the household maintenance domain and at least 3 non-missing items for the other domains. Total score is the mean across the six domains. So total and domain scores range from 0 to 3, with higher scores indicating higher levels of functional activity within and across domains. Respondents engaged in many activities with no difficulty will score high on the FPI, while those who perform few activities with much difficulty will score low. | Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included. | Posted | Least Squares Mean | Standard Error | Units on a scale | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 12 Weeks | Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of maximum oxygen consumption (VO2 peak) after 12 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then the ANCOVA was fitted to the log10-transformed data and the least square means and SE were obtained. To present the results in a way easier for interpretation, the least square mean from the ANCOVA fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate to obtain the geometric mean and the corresponding SE was transformed using delta method to get the corresponding SE of the geometric mean. | Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included. | Posted | Geometric Mean | Standard Error | Second | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | One Hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 8 Weeks of Treatment | One hour, Post-dose Forced Expiratory Volume in One Second (FEV1) after 8 weeks of treatment. | Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included. | Posted | Least Squares Mean | Standard Error | Liter | Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | One Hour, Post-dose Forced Vital Capacity (FVC) After 8 Weeks of Treatment | One hour, Post-dose Forced Vital Capacity (FVC) after 8 weeks of treatment. | Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included. | Posted | Least Squares Mean | Standard Error | Liter | Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Resting Inspiratory Capacity (IC) Measured at 1.5 Hours Post Dose After 8 Weeks of Treatment | Resting inspiratory capacity (IC) measured at 1.5 hours post dose after 8 weeks of treatment. | Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included. | Posted | Least Squares Mean | Standard Error | Liter | Week 8 |
|
From first dose of study medication up to a period of 21 days after the last dose of study medication were assigned to the treatment period, up to 134 days.
All adverse events, serious and non-serious, occurring during the course of the clinical trial (i.e. from signing the informed consent onwards through the observational phase) were to be collected, documented and reported to the sponsor by the investigator on the appropriate electronic case report form / serious adverse event reporting forms.
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 | Placebo With Behavioural Modification (BM) | Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks. | 4 | 75 | 22 | 75 | ||
| EG001 | Tiotropium (Tio) 5 Micro-grams (μg) With BM | Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks. | 11 | 76 | 19 | 76 | ||
| EG002 | Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM | Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks. | 3 | 76 | 16 | 76 | ||
| EG003 | Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM | Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks. | 8 | 76 | 19 | 76 | ||
| EG004 | Total | Total | 26 | 303 | 76 | 303 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Malignant genitourinary tract neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma unspecified histology indolent stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary hilum mass | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C549647 | olodaterol |
| C000611386 | tiotropium-olodaterol |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
Not provided
Not provided
| Male |
|
| No |
| Superiority or Other |
| This treatment comparison is the second one in the alpha-protected hierarchical testing chain. | ANCOVA | Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method. | 0.0109 | ANCOVA model with categorical effect of treatment and baseline as covariate. | Treatment ratio | 1.292 | Standard Error of the Mean | 0.129 | 2-Sided | 95 | 1.061 | 1.573 | Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM). | No | Superiority or Other |
| This treatment comparison is the third one in the alpha-protected hierarchical testing chain. Since the p-value for this treatment comparison is >0.05, the hierarchical testing chain is broken and all of the following hypothesis tests in this hierarchical chain are considered as descriptive only. | ANCOVA | Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method. | 0.6895 | ANCOVA model with categorical effect of treatment and baseline as covariate. | Treatment ratio | 1.041 | Standard Error of the Mean | 0.106 | 2-Sided | 95 | 0.853 | 1.272 | Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM). | No | Superiority or Other |
| ANCOVA | Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method. | 0.2188 | ANCOVA model with categorical effect of treatment and baseline as covariate. | Treatment ratio | 1.128 | Standard Error of the Mean | 0.110 | 2-Sided | 95 | 0.931 | 1.368 | Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM. | No | Superiority or Other |
| ANCOVA | Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method. | 0.0303 | ANCOVA model with categorical effect of treatment and baseline as covariate. | Treatment ratio | 1.241 | Standard Error of the Mean | 0.123 | 2-Sided | 95 | 1.021 | 1.507 | Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM. | No | Superiority or Other |
| OG003 | Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM | Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks. |
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| OG002 | Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM | Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks. |
| OG003 | Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM | Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks. |
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| OG001 | Tiotropium (Tio) 5 Micro-grams (μg) With BM | Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks. |
| OG002 | Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM | Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks. |
| OG003 | Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM | Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks. |
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Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks. |
| OG002 | Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM | Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks. |
| OG003 | Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM | Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks. |
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| OG003 | Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM | Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks. |
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| OG003 | Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM | Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks. |
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| OG003 | Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM | Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks. |
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