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Real-world data on the effects of a fixed-dose combination Long-acting beta agonists + long-acting antimuscarinic agent (LABA+LAMA) therapy with tiotropium and olodaterol administered in a single device, in COPD patients who need treatment with two long-acting bronchodilators, is not available. This is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto Respimat according to the approved Summary of Product Characteristics (SmPC).
Purpose:
Study Design:
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Therapeutic Success After Approximately 6 Weeks. | The therapeutic success was defined as a minimum of 10- point increase in the Physical Functioning (PF-10) score between visit 1 (baseline visit at the start of the study) and visit 2 (final visit approximately 6 weeks after visit 1), having approximately time period of 6 weeks between the evaluated questionnaires. PF-10 score measures changes in physical functioning - serving as a surrogate for physical activity and exercise capacity - in COPD patients. | Approximately 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Physical Functioning (PF-10) Score From Baseline (visit1) to Approximately 6 Weeks (visit2) | Change in PF-10 score was determined by taking into account the individual change of each patient between visit 1 and visit 2. The PF-10 used for assessing the primary outcome is a sub-domain of the validated Short Form (SF)-36 quality of life questionnaire and consists of 10 questions evaluating the experienced restrictions while conducting usual activities. Each question of the PF-10 may be answered with "yes, limited a lot", "yes, limited a little", or "No, not limited at all", with a score of 1, 2, or 3, respectively. The scores will be summed up between 10 and 30. The final sum of the individual scores was standardized to a range of 0 to 100 using the formula: 100*(sum-10)/20. The lower the score the more disability. The higher the score the less disability. If less than half of the scale items were missing, missing values were replaced with the mean of the other values. If half or more than half was missing, no score was calculated. |
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Inclusion criteria:
Exclusion criteria:
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COPDS patients
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Austria | |||||
| 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 the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be entered to trial if any one of the specific entry criteria were not met.
This is an open label observational study in Chronic Obstructive Pulmonary Disease (COPD) patients from 534 investigational sites in 9 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patients with Chronic Obstructive Pulmonary Disease (COPD) included in this group were treated with Spiolto® Respimat®, Tiotropium/ Olodaterol 2.5 microgram/ 2.5 microgram, inhalation solution for 6 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treated set (TS): All patients enrolled, registered and received at least one dose were included in the treated set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patients with Chronic Obstructive Pulmonary Disease (COPD) included in this group were treated with Spiolto® Respimat®, Tiotropium/ Olodaterol 2.5 microgram/ 2.5 microgram, inhalation solution for 6 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Treated set (TS): All patients enrolled, registered and received at least one dose were included in the treated set. |
| 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 After Approximately 6 Weeks. | The therapeutic success was defined as a minimum of 10- point increase in the Physical Functioning (PF-10) score between visit 1 (baseline visit at the start of the study) and visit 2 (final visit approximately 6 weeks after visit 1), having approximately time period of 6 weeks between the evaluated questionnaires. PF-10 score measures changes in physical functioning - serving as a surrogate for physical activity and exercise capacity - in COPD patients. | Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set. | Posted | Number | 95% Confidence Interval | Percentage of participants (%) | Approximately 6 weeks |
|
From first dose adminstration until 21 days after permanently discontinuation of therapy or end of the study.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Analysis of adverse events were done on Treated set, which includes all patients enrolled, registered and received at least one dose.
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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® 2.5 Microgram/ 2.5 Microgram | Patients with Chronic Obstructive Pulmonary Disease (COPD) included in this group were treated with Spiolto® Respimat®, Tiotropium/ Olodaterol 2.5 microgram/ 2.5 microgram, inhalation solution for 6 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | 20.0 | Systematic Assessment |
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The impact and the interpretation of this data are limited due to the non-interventional study concept. No objective assessment was performed. It might be considered that patients may get used to limited activity and overrate their baseline activity
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | 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 | May 29, 2017 | May 28, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Nov 16, 2015 | May 28, 2018 | Prot_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 |
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| Baseline and week 6 |
| General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2). | This outcome measures general condition of the patient evaluated by the physician (PGE score) at visit 1 (baseline visit at the start of the study) and visit 2 (final visit approximately 6 weeks after visit 1) evaluated on an 8-point scale with the scores "Poor (1,2)", "Satisfactory (3, 4)", "Good (5, 6)" and "Excellent (7, 8)". More the score, the better is the general condition of patient. | Baseline and week 6 |
| Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | At visit 2 patients were asked for their overall satisfaction with the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases. | Approximately 6 weeks |
| Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | At visit 2 patients were asked how satisfied they were with inhaling from the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases. | Approximately 6 weeks |
| Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | At visit 2 patients were asked how satisfied they were with handling the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases. | Approximately 6 weeks |
| Multiple Locations |
| Czechia |
| Multiple Locations | Hungary |
| Multiple Locations | Israel |
| Multiple Locations | Romania |
| Multiple Locations | Russia |
| Multiple Locations | Slovakia |
| Multiple Locations | Slovenia |
| Multiple Locations | Switzerland |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Treated set (TS): All patients enrolled, registered and received at least one dose were included in the treated set. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Patients with Chronic Obstructive Pulmonary Disease (COPD) included in this group were treated with Spiolto® Respimat®, Tiotropium/ Olodaterol 2.5 microgram/ 2.5 microgram, inhalation solution for 6 weeks.
|
|
| Secondary | Change in the Physical Functioning (PF-10) Score From Baseline (visit1) to Approximately 6 Weeks (visit2) | Change in PF-10 score was determined by taking into account the individual change of each patient between visit 1 and visit 2. The PF-10 used for assessing the primary outcome is a sub-domain of the validated Short Form (SF)-36 quality of life questionnaire and consists of 10 questions evaluating the experienced restrictions while conducting usual activities. Each question of the PF-10 may be answered with "yes, limited a lot", "yes, limited a little", or "No, not limited at all", with a score of 1, 2, or 3, respectively. The scores will be summed up between 10 and 30. The final sum of the individual scores was standardized to a range of 0 to 100 using the formula: 100*(sum-10)/20. The lower the score the more disability. The higher the score the less disability. If less than half of the scale items were missing, missing values were replaced with the mean of the other values. If half or more than half was missing, no score was calculated. | Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set. | Posted | Mean | Standard Deviation | Score on scale | Baseline and week 6 |
|
|
|
| Secondary | General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2). | This outcome measures general condition of the patient evaluated by the physician (PGE score) at visit 1 (baseline visit at the start of the study) and visit 2 (final visit approximately 6 weeks after visit 1) evaluated on an 8-point scale with the scores "Poor (1,2)", "Satisfactory (3, 4)", "Good (5, 6)" and "Excellent (7, 8)". More the score, the better is the general condition of patient. | Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set. | Posted | Number | Participants | Baseline and week 6 |
|
|
|
| Secondary | Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | At visit 2 patients were asked for their overall satisfaction with the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases. | Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set. | Posted | Number | Participants | Approximately 6 weeks |
|
|
|
| Secondary | Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | At visit 2 patients were asked how satisfied they were with inhaling from the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases. | Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set. | Posted | Number | Participants | Approximately 6 weeks |
|
|
|
| Secondary | Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | At visit 2 patients were asked how satisfied they were with handling the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases. | Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set. | Posted | Number | Participants | Approximately 6 weeks |
|
|
|
| 4 |
| 7,443 |
| 5 |
| 7,443 |
| 0 |
| 7,443 |
| Pneumonia | Infections and infestations | 20.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | 20.0 | Systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | Systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | Systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Score 4 at visit 1 |
|
| Score 5 at visit 1 |
|
| Score 6 at visit 1 |
|
| Score 7 at visit 1 |
|
| Score 8 at visit 1 |
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| Score 1 at visit 2 |
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| Score 2 at visit 2 |
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| Score 3 at visit 2 |
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| Score 4 at visit 2 |
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| Score 5 at visit 2 |
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| Score 6 at visit 2 |
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| Score 7 at visit 2 |
|
| Score 8 at visit 2 |
|
| Title | Measurements |
|---|---|
|
| Neither satisfied nor dissatisfied |
|
| Rather dissatisfied |
|
| Dissatisfied |
|
| Very dissatisfied |
|
| Not answered |
|
| Title | Measurements |
|---|---|
|
| Neither satisfied nor dissatisfied |
|
| Rather dissatisfied |
|
| Dissatisfied |
|
| Very dissatisfied |
|
| Not answered |
|
| Title | Measurements |
|---|---|
|
| Neither satisfied nor dissatisfied |
|
| Rather dissatisfied |
|
| Dissatisfied |
|
| Very dissatisfied |
|
| Not answered |
|