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The primary objective of the study is to measure changes in physical functioning - serving as a surrogate for physical activity and exercise capacity - in COPD patients being treated with Spiolto® Respimat® after approximately 6 weeks. A secondary objective is to evaluate the patient¿s general condition (physician¿s evaluation) at visit 1 (baseline visit at the start of the study) and at visit 2 (final visit at the end of the study, approx. 6 weeks after visit 1), as well as patient satisfaction with Spiolto® Respimat® at visit 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spiolto Respimat | COPD patients requiring a fixed combination therapy of two long-acting bronchodilators (LAMA + LABA) according to approved Summary of Product Characteristics (SmPC) and Global Initiative for Chronic Obstructive Lung Disease (GOLD)guidelines |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spiolto Respimat | Drug | Tiotropium bromide + Olodaterol |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Therapeutic Success at Week 6 (Approx.) (Visit 2). | Therapeutic success defined as a minimum 10-point increase of Physical functioning questionnaire (PF-10 ) score after approximately 6 weeks of Spiolto® Respimat® treatment The PF-10 used for assessing the primary outcome "physical functioning" is a sub-domain of the validated Short Form 36 (SF-36) quality of life questionnaire and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. The total score ranges from 0 to 100. A higher score indicates a better physical functioning. | after approximately 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the PF-10 Score From Visit 1 to Visit 2 | Change in PF-10 score was determined by taking into account the individual change of each patient between Baseline (Visit 1) and Week 6 (approx.) (Visit 2). | baseline and approx. week 6 |
| General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. |
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Inclusion criteria:
Exclusion criteria:
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COPD patients
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32857327 | Derived | Taube C, Bayer V, Zehendner CM, Valipour A. Assessment of Patient Experiences with Respimat(R) in Everyday Clinical Practice. Pulm Ther. 2020 Dec;6(2):371-380. doi: 10.1007/s41030-020-00127-4. Epub 2020 Aug 28. |
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All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be entered to trial drug if any of the specific entry criteria was violated.
1737 patients were treated. Of these 1578 patients had both visits documented as well as filled in all questionnaires, thus being evaluable for analysis of primary and secondary endpoints .
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| ID | Title | Description |
|---|---|---|
| FG000 | Spiolto Respimat | COPD patients were administered 2.5 microgram/2.5 microgram per puff inhalation solution of the fixed combination therapy of two long-acting bronchodilators (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 adrenoceptor agonist (LABA)) via one device Respimat® for approximately 6 weeks according to approved Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 3, 2015 | Mar 8, 2018 |
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Physician's Global Evaluation (PGE) score documented by physicians at visit 1 (baseline) and at visit 2 (approx. 6 weeks later). the PGE score documented from 1 to 8. The highest value (=8) representing an excellent general condition |
| Baseline (Visit 1) and Week 6 (approx.) (Visit 2) |
| Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2). | At Week 6 (approx.) (Visit 2) patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment. | Week 6 (approx.) (Visit 2) |
| Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2). | At Week 6 (approx.) (Visit 2) patients were asked how satisfied they were by inhaling with the Respimat® device. | Week 6 (approx.) (Visit 2) |
| Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2). | At Week 6 (approx.) (Visit 2) patients were asked how satisfied they were with handling of the Respimat® inhalation device | Week 6 (approx.) (Visit 2) |
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Treated set (TS): All patients who had given their written informed consent to study participation, had been registered and had received at least one dose of Spiolto® Respimat® were included in the Treatet set (TS).
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| ID | Title | Description |
|---|---|---|
| BG000 | Spiolto Respimat | COPD patients were administered 2.5 microgram/2.5 microgram per puff inhalation solution of the fixed combination therapy of two long-acting bronchodilators (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 adrenoceptor agonist (LABA)) via one device Respimat® for approximately 6 weeks according to approved Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at the time of registration was captured | Treated set | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| 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 | Percentage of Patients With Therapeutic Success at Week 6 (Approx.) (Visit 2). | Therapeutic success defined as a minimum 10-point increase of Physical functioning questionnaire (PF-10 ) score after approximately 6 weeks of Spiolto® Respimat® treatment The PF-10 used for assessing the primary outcome "physical functioning" is a sub-domain of the validated Short Form 36 (SF-36) quality of life questionnaire and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. The total score ranges from 0 to 100. A higher score indicates a better physical functioning. | Full analysis set (FAS): This analysis set consist of all screened patients with informed consent, date of registration, at least one documented administration of Spiolto® Respimat® & available PF-10 score at visit 1&2, & confirmed main diagnosis of COPD in whom treatment with long-acting anticholinergics plus bronchodilators is indicated. | Posted | Number | 95% Confidence Interval | Percentage of patients | after approximately 6 weeks |
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| Secondary | Changes in the PF-10 Score From Visit 1 to Visit 2 | Change in PF-10 score was determined by taking into account the individual change of each patient between Baseline (Visit 1) and Week 6 (approx.) (Visit 2). | FAS | Posted | Mean | Standard Deviation | Unit on Scale | baseline and approx. week 6 |
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| Secondary | General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. | Physician's Global Evaluation (PGE) score documented by physicians at visit 1 (baseline) and at visit 2 (approx. 6 weeks later). the PGE score documented from 1 to 8. The highest value (=8) representing an excellent general condition | FAS | Posted | Number | Percentage of participants | Baseline (Visit 1) and Week 6 (approx.) (Visit 2) |
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| Secondary | Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2). | At Week 6 (approx.) (Visit 2) patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment. | FAS | Posted | Number | Percentage of participants | Week 6 (approx.) (Visit 2) |
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| Secondary | Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2). | At Week 6 (approx.) (Visit 2) patients were asked how satisfied they were by inhaling with the Respimat® device. | Posted | Number | percentage of participants | Week 6 (approx.) (Visit 2) |
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| Secondary | Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2). | At Week 6 (approx.) (Visit 2) patients were asked how satisfied they were with handling of the Respimat® inhalation device | FAS | Posted | Number | percentage of participants | Week 6 (approx.) (Visit 2) |
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From first drug administration until end of study, up to approx 6 weeks.
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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 | Spiolto Respimat | COPD patients were administered 2.5 microgram/2.5 microgram per puff inhalation solution of the fixed combination therapy of two long-acting bronchodilators (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 adrenoceptor agonist (LABA)) via one device Respimat® for approximately 6 weeks according to approved Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines | 2 | 1,737 | 3 | 1,737 | 0 | 1,737 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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The impact and the interpretation of this Non Interventional Study (NIS) data are limited due to NIS concept
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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 29, 2016 | Mar 8, 2018 | SAP_001.pdf |
| 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 |
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| ID | Term |
|---|---|
| C000611386 | tiotropium-olodaterol |
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