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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004659-37 | EudraCT Number | EudraCT |
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The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiotropium + olodaterol High dose QD | Experimental | patient will receive tiotropium 5 mcg + olodaterol 5 mcg in a fixed dose combination once daily |
|
| Tiotropium + olodaterol Low dose QD | Experimental | patient will receive tiotropium 2.5 mcg + olodaterol 5 mcg in a fixed dose combination once daily |
|
| Tiotropium 5 mcg QD | Active Comparator | patient will receive tiotropium 5 mcg once daily |
|
| Olodaterol 5 mcg QD | Active Comparator | patient will receive olodaterol 5 mcg once daily |
|
| Placebo QD | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | placebo matching tiotropium + olodaterol FDC |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap | Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap). Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted means from the MMRM (Mixed Effects Model Repeated Measures) model. | 6 weeks |
| Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap | Endurance time during constant work rate cycle ergometry (CWRCE) to symptom limitation at 75% work capacity (Wcap). Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted mean from the MMRM model. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Slope of the Intensity of Breathing Discomfort During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity | Slope of the intensity of breathing discomfort during Constant Work Rate Cycle Ergometry (CWRCE) to symptom limitation at 75% Work capacity (Wcap). The intensity of breathing discomfort was rated using the modified Borg scale with ratings from 0 (nothing at all) to 10 (maximal). Slope of breathing discomfort is defined as: (intensity of breathing discomfort at the end of exercise minus intensity of breathing discomfort at rest) / endurance time. A decrease in slope indicates improvement. The presented means are adjusted means from MMRM model. |
Not provided
Inclusion criteria:
All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 <80% of predicted normal and a post-bronchodilator FEV1/FVC <70% at Visit 1.
Male or female patients, between 40 and 75 years of age (inclusive) on day of signing informed consent.
Patients must be current or ex-smokers with a smoking history of more than 10 pack years.
Exclusion criteria:
Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study
Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT >x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN will be excluded regardless of clinical condition
Patients with a history of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma.
Patients with any of the following conditions:
A diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists)
A diagnosis of paroxysmal tachycardia (>100 beats per minute) (due to the known class side effect profile of ß2-agonists)
A history of myocardial infarction within 1 year of screening visit (Visit 1)
Unstable or life-threatening cardiac arrhythmia
Hospitalized for heart failure within the past year
Known active tuberculosis
A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed)
A history of life-threatening pulmonary obstruction
A history of cystic fibrosis
Clinically evident bronchiectasis
A history of significant alcohol or drug abuse
Any contraindications for exercise testing.
Patients who have undergone thoracotomy with pulmonary resection (patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1)
Patients being treated with any oral ß-adrenergics
Patients being treated with oral corticosteroid medication at unstable doses
Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits
Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program
Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris or claudication or morbid obesity.
Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit
Patients with known hypersensitivity to ß-adrenergics drugs, anticholinergic drugs, BAC, EDTA or any other component of the Respimat® inhalation solution delivery system
Pregnant or nursing women
Women of childbearing potential not using highly effective methods of birth control.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1237.13.01302 Boehringer Ingelheim Investigational Site | Torrance | California | United States | |||
| 1237.13.01308 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28424359 | Derived | O'Donnell DE, Casaburi R, Frith P, Kirsten A, De Sousa D, Hamilton A, Xue W, Maltais F. Effects of combined tiotropium/olodaterol on inspiratory capacity and exercise endurance in COPD. Eur Respir J. 2017 Apr 19;49(4):1601348. doi: 10.1183/13993003.01348-2016. Print 2017 Apr. |
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This was a randomised, 4-period incomplete block cross-over trial. 295 patients were randomized to one of five treatments sequences and treated. It was a double-blind trial in which each treatment period lasted 6 weeks with a washout period of 21 days between each.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio / Olo | Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tiotropium |
| Drug |
Tiotropium 5 mcg once daily |
|
| Olodaterol | Drug | Olodaterol 5 mcg once daily |
|
| tiotropium + olodaterol | Drug | tiotropium + olodaterol 5 mcg once daily |
|
| Tiotropium + Olodaterol | Drug | Tiotropium 2.5 mcg + Olodaterol 5 mcg once daily |
|
| Respimat | Device | Respimat inhaler |
|
| 6 weeks |
| Forced Expiratory Volume in 1 Second (One Hour Post-dose) | Forced Expiratory Volume in 1 Second (FEV1) (one hour post-dose) The presented means are adjusted means from MMRM model. | 6 weeks |
| Hartford |
| Connecticut |
| United States |
| 1237.13.01304 Boehringer Ingelheim Investigational Site | Livonia | Michigan | United States |
| 1237.13.01307 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | United States |
| 1237.13.01305 Boehringer Ingelheim Investigational Site | Easley | South Carolina | United States |
| 1237.13.01301 Boehringer Ingelheim Investigational Site | Greenville | South Carolina | United States |
| 1237.13.01303 Boehringer Ingelheim Investigational Site | Spartanburg | South Carolina | United States |
| 1237.13.01306 Boehringer Ingelheim Investigational Site | Richmond | Virginia | United States |
| 1237.13.54301 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina |
| 1237.13.54302 Boehringer Ingelheim Investigational Site | Mar del Plata | Argentina |
| 1237.13.61306 Boehringer Ingelheim Investigational Site | Concord | New South Wales | Australia |
| 1237.13.61301 Boehringer Ingelheim Investigational Site | Daw Park | South Australia | Australia |
| 1237.13.61305 Boehringer Ingelheim Investigational Site | Toorak Gardens | South Australia | Australia |
| 1237.13.61304 Boehringer Ingelheim Investigational Site | Footscray | Victoria | Australia |
| 1237.13.61302 Boehringer Ingelheim Investigational Site | Prahran | Victoria | Australia |
| 1237.13.43303 Boehringer Ingelheim Investigational Site | Linz | Austria |
| 1237.13.43301 Boehringer Ingelheim Investigational Site | Thalheim bei Wels | Austria |
| 1237.13.32302 Boehringer Ingelheim Investigational Site | Brussels | Belgium |
| 1237.13.32303 Boehringer Ingelheim Investigational Site | Edegem | Belgium |
| 1237.13.32305 Boehringer Ingelheim Investigational Site | Jambes | Belgium |
| 1237.13.32304 Boehringer Ingelheim Investigational Site | Lanaken | Belgium |
| 1237.13.32301 Boehringer Ingelheim Investigational Site | Leuven | Belgium |
| 1237.13.11302 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada |
| 1237.13.11303 Boehringer Ingelheim Investigational Site | Kingston | Ontario | Canada |
| 1237.13.11304 Boehringer Ingelheim Investigational Site | Saskatoon | Saskatchewan | Canada |
| 1237.13.56301 Boehringer Ingelheim Investigational Site | Chile | Chile |
| 1237.13.56302 Boehringer Ingelheim Investigational Site | Santiago | Chile |
| 1237.13.49302 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1237.13.49307 Boehringer Ingelheim Investigational Site | Dortmund | Germany |
| 1237.13.49304 Boehringer Ingelheim Investigational Site | Frankfurt | Germany |
| 1237.13.49301 Boehringer Ingelheim Investigational Site | Halle | Germany |
| 1237.13.49303 Boehringer Ingelheim Investigational Site | Hanover | Germany |
| 1237.13.49305 Boehringer Ingelheim Investigational Site | Lübeck | Germany |
| 1237.13.39302 Boehringer Ingelheim Investigational Site | Genova | Italy |
| 1237.13.39304 Boehringer Ingelheim Investigational Site | Parma | Italy |
| 1237.13.39303 Boehringer Ingelheim Investigational Site | Pavia | Italy |
| 1237.13.39305 Boehringer Ingelheim Investigational Site | Pavullo Nel Frignano (mo) | Italy |
| 1237.13.39301 Boehringer Ingelheim Investigational Site | Pisa | Italy |
| 1237.13.39312 Boehringer Ingelheim Investigational Site | Pisa | Italy |
| 1237.13.39310 Boehringer Ingelheim Investigational Site | Roma | Italy |
| 1237.13.39308 Boehringer Ingelheim Investigational Site | Sesto S. Giovanni (mi) | Italy |
| 1237.13.39306 Boehringer Ingelheim Investigational Site | Trieste | Italy |
| 1237.13.64302 Boehringer Ingelheim Investigational Site | Christchurch | New Zealand |
| 1237.13.64301 Boehringer Ingelheim Investigational Site | Greenlane East Auckland NZ | New Zealand |
| FG001 | Tio+Olo 5/5 / Tio / Olo / Placebo | Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:
|
| FG002 | Tio / Olo / Placebo / Tio+Olo 2.5/5 | Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:
|
| FG003 | Olo / Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5 | Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:
|
| FG004 | Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio | Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:
|
| Received Placebo |
|
| Received Olo 5 |
|
| Received Tio 5 |
|
| Received Tio+Olo 2.5/5 |
|
| Received Tio+Olo 5/5 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated Set (TS) : This patient set included all patients of the Randomised Set (RS : patients who signed the informed consent form and were also randomised, regardless of whether the patient was treated with study medication or not) who were dispensed study medication and were documented to have taken at least 1 dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | A randomised, double-blind, placebo controlled, 5 treatment, 4-period, incomplete, crossover study. Each treatment period was separated by a washout period of 21 days. The 5 treatments, administered orally via the respimat inhaler, once daily, in the morning were:
Treatment sequence is not considered as a factor which may affect the treatment effect due to sufficient washout period added between treatment cycles. As a result, we only display baseline characteristics as a whole population, but not by treatment sequence |
| 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 |
| |||||||||||||||||
| Sex: Female, Male | 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 | Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap | Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap). Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted means from the MMRM (Mixed Effects Model Repeated Measures) model. | Full Analysis Set (FAS) : This patient set included all patients in the TS who had the study baseline and at least 1 evaluable post-dose measurement for 1 of the primary endpoints. Assignment to the FAS was done after implementation of any data handling rules,which set measurements to missing. | Posted | Mean | Standard Error | Litres | 6 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap | Endurance time during constant work rate cycle ergometry (CWRCE) to symptom limitation at 75% work capacity (Wcap). Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted mean from the MMRM model. | FAS | Posted | Geometric Mean | Standard Error | seconds | 6 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Slope of the Intensity of Breathing Discomfort During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity | Slope of the intensity of breathing discomfort during Constant Work Rate Cycle Ergometry (CWRCE) to symptom limitation at 75% Work capacity (Wcap). The intensity of breathing discomfort was rated using the modified Borg scale with ratings from 0 (nothing at all) to 10 (maximal). Slope of breathing discomfort is defined as: (intensity of breathing discomfort at the end of exercise minus intensity of breathing discomfort at rest) / endurance time. A decrease in slope indicates improvement. The presented means are adjusted means from MMRM model. | FAS | Posted | Mean | Standard Error | units on a scale / second | 6 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Forced Expiratory Volume in 1 Second (One Hour Post-dose) | Forced Expiratory Volume in 1 Second (FEV1) (one hour post-dose) The presented means are adjusted means from MMRM model. | FAS | Posted | Mean | Standard Error | Litres | 6 weeks |
|
From drug administration until 21 days after the last administration, up to 120 days
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning. | 4 | 222 | 26 | 222 | ||
| EG001 | Olodaterol 5 µg | Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | 3 | 217 | 17 | 217 | ||
| EG002 | Tiotropium 5 µg | Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | 8 | 226 | 20 | 226 | ||
| EG003 | Tiotropium + Olodaterol 2.5/5 | Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | 5 | 222 | 13 | 222 | ||
| EG004 | Tiotropium + Olodaterol 5/5 | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | 6 | 226 | 19 | 226 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Congenital cystic kidney disease | Congenital, familial and genetic disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Hypothermia | General disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Biliary tract disorder | Hepatobiliary disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MEDDRA 16.1 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MEDDRA 16.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MEDDRA 16.1 | Systematic Assessment |
| |
| Wound abscess | Infections and infestations | MEDDRA 16.1 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MEDDRA 16.1 | Systematic Assessment |
| |
| Splenic rupture | Injury, poisoning and procedural complications | MEDDRA 16.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MEDDRA 16.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MEDDRA 16.1 | Systematic Assessment |
| |
| Blepharal papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.1 | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 16.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.1 | Systematic Assessment |
| |
| Cardiac pacemaker insertion | Surgical and medical procedures | MEDDRA 16.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MEDDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.1 | 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 |
|---|---|
| D000069447 | Tiotropium Bromide |
| C549647 | olodaterol |
| C000611386 | tiotropium-olodaterol |
| 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
| Mixed Models Analysis |
| <0.0001 |
| Mean Difference (Final Values) |
| 0.119 |
| Standard Error of the Mean |
| 0.027 |
| 2-Sided |
| 95 |
| 0.065 |
| 0.172 |
Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg |
| No |
| Superiority or Other |
| Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | 0.114 | Standard Error of the Mean | 0.027 | 2-Sided | 95 | 0.061 | 0.167 | Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD | No | Superiority or Other |
| Mixed Models Analysis | <0.0001 | Mean Difference (Final Values) | 0.218 | Standard Error of the Mean | 0.027 | 2-Sided | 95 | 0.164 | 0.271 | Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD | No | Superiority or Other |
| Mixed Models Analysis | 0.0008 | Mean Difference (Final Values) | 0.092 | Standard Error of the Mean | 0.027 | 2-Sided | 95 | 0.038 | 0.145 | Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD | No | Superiority or Other |
| Mixed Models Analysis | 0.0015 | Mean Difference (Final Values) | 0.087 | Standard Error of the Mean | 0.027 | 2-Sided | 95 | 0.034 | 0.141 | Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD | No | Superiority or Other |
Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
| OG004 | Tiotropium + Olodaterol 5/5 | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
|
|
|
| OG003 | Tiotropium + Olodaterol 2.5/5 | Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG004 | Tiotropium + Olodaterol 5/5 | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
|
|
|
| OG004 | Tiotropium + Olodaterol 5/5 | Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
|
|
|