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Recruitment failure
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The primary objective of this Non Interventional Study is to measure changes in physical functioning, a surrogate for physical activity and exercise capacity, in COPD patients on treatment with Spiolto® Respimat® in routine daily treatment after approximately 6 weeks.
A secondary objective is to evaluate the patient's general condition (physician's evaluation) from Visit 1 (baseline visit at the start of the study) to 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spiolto Respimat | Drug | Tiotropium bromide + Olodaterol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Therapeutic Success After Approximately (Approx.) 6 Weeks After Baseline | "Therapeutic success" is defined as a 10-point increase of physical functioning (PF)-10 between Visit 1 (baseline) and Visit 2 (approx. 6 weeks later) using a PF questionnaire, which is a subdomain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can 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. The scores over the 10 questions will be summed, resulting in a value between 10 (a patient answering all questions with "yes, limited a lot") and 30 (a patient answering all questions with "No, not limited at all"). The final sum of the individual scores will be standardized to a range of 0 to 100 using the following formula: 100*(sum-10)/20. Percentage of patients with therapeutic success after approximately 6 weeks after baseline are presented | Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 (Approx. 6 Weeks Later) | Change in PF-10 score was determined by taking into account the individual change of each patient between Visit 1 and Visit 2. PF questionnaire, is a sub-domain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can 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. The scores over the 10 questions will be summed, resulting in a value between 10 (a patient answering all questions with "yes, limited a lot") and 30 (a patient answering all questions with "No, not limited at all"). The final sum of the individual scores will be standardized to a range of 0 to 100 using the following formula: 100*(sum-10)/20. |
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Inclusion criteria:
Exclusion criteria:
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Chronic Obstructive Pulmonary Disease (COPD) patients
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Belgium | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34394782 | Derived | Spielmanns M, Tamm M, Schildge S, Valipour A. Swiss Experience in Therapy With Dual Bronchodilation in Chronic Obstructive Pulmonary Disease in Relation to Self-Reported Physical Functionality. J Clin Med Res. 2021 Jul;13(7):392-402. doi: 10.14740/jocmr4542. Epub 2021 Jul 28. |
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Patients were enrolled consecutively and were followed over an observational period of approximately 6 weeks, which was the average time between two medical consultations
This was an open-label observational study conducted in 6 countries, enrolling consented Chronic Obstructive Pulmonary Disorder (COPD) patients who received treatment with Spiolto® Respimat® according to the approved summary of product characteristics (SmPc).
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| ID | Title | Description |
|---|---|---|
| FG000 | Tiotropium + Olodaterol FDC | Patients were administered Tiotropium + olodaterol fixed-dose combination (FDC) using the Respimat® inhaler (Spiolto® Respimat® 2.5 microgram/2.5 microgram) as an inhalation solution. Tiotropium + olodaterol FDC is an aqueous solution of tiotropium and olodaterol contained in a cartridge. One cartridge is used per inhaler, which is inserted into the device prior to first use |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Treated set (TS): Patients that were enrolled, registered and received at least one dose of Spiolto® Respimat® were included in the Treated Set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tiotropium + Olodaterol FDC | Patients were administered Tiotropium + olodaterol fixed-dose combination (FDC) using the Respimat® inhaler (Spiolto® Respimat® 2.5 microgram/2.5 microgram) as an inhalation solution. Tiotropium + olodaterol FDC is an aqueous solution of tiotropium and olodaterol contained in a cartridge. One cartridge is used per inhaler, which is inserted into the device prior to first use |
| 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 | Mean |
| 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 (Approx.) 6 Weeks After Baseline | "Therapeutic success" is defined as a 10-point increase of physical functioning (PF)-10 between Visit 1 (baseline) and Visit 2 (approx. 6 weeks later) using a PF questionnaire, which is a subdomain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can 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. The scores over the 10 questions will be summed, resulting in a value between 10 (a patient answering all questions with "yes, limited a lot") and 30 (a patient answering all questions with "No, not limited at all"). The final sum of the individual scores will be standardized to a range of 0 to 100 using the following formula: 100*(sum-10)/20. Percentage of patients with therapeutic success after approximately 6 weeks after baseline are presented | Full analysis set (FAS): Patients that were enrolled, registered and received at least one dose of treatment with Spiolto® Respimat® and had baseline and week 6 visit documented as well as completed all questionnaires were included in FAS | Posted | Number | 95% Confidence Interval | percentage of participants | Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later) |
Data to be collected from signing the informed consent onwards until the end of the study; up to 6 weeks
The following had to be collected from signing the informed consent onwards until the end of the study:
Treated set is the population set used for reporting Adverse events.
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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 | Tiotropium + Olodaterol FDC | Patients were administered Tiotropium + olodaterol fixed-dose combination (FDC) using the Respimat® inhaler (Spiolto® Respimat® 2.5 microgram/2.5 microgram) as an inhalation solution. Tiotropium + olodaterol FDC is an aqueous solution of tiotropium and olodaterol contained in a cartridge. One cartridge is used per inhaler, which is inserted into the device prior to first use |
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The impact and the interpretation of this non-interventional (NIS) data are limited due to the non-interventional study concept
| 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 |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 21, 2017 | Dec 13, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 25, 2017 | Dec 13, 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 |
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| ID | Term |
|---|---|
| C000611386 | tiotropium-olodaterol |
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| Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later) |
| General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later) | The treating physician used the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8(excellent). PGE will be completed before and approx. 6 weeks after treatment initiation. Count of patients with PGE score 2, 3, 4, 5, 6, 7, 8 are presented for Visit 1 and Visit 2. | Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later) |
| Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction | A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied. Count of patients with divisions from very dissatisfied to very satisfied are presented. | Visit 2 (approx. 6 weeks post baseline) |
| Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device | A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied. Count of patients with divisions from very dissatisfied to very satisfied are presented. | Visit 2 (approx. 6 weeks post baseline) |
| Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device | A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied. Count of patients with divisions from very dissatisfied to very satisfied are presented. | Visit 2 (approx. 6 weeks post baseline) |
| Multiple Locations |
| Denmark |
| Multiple Locations | Luxembourg |
| Multiple Locations | Netherlands |
| One Or Multiple Investigational Sites | Portugal |
| One Or Multiple Investigational Site | Sweden |
| Patients wish to withdraw |
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| Missing |
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| General exclusion |
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| 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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| Secondary | Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 (Approx. 6 Weeks Later) | Change in PF-10 score was determined by taking into account the individual change of each patient between Visit 1 and Visit 2. PF questionnaire, is a sub-domain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can 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. The scores over the 10 questions will be summed, resulting in a value between 10 (a patient answering all questions with "yes, limited a lot") and 30 (a patient answering all questions with "No, not limited at all"). The final sum of the individual scores will be standardized to a range of 0 to 100 using the following formula: 100*(sum-10)/20. | FAS | Posted | Mean | Standard Deviation | scores on a scale | Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later) |
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| Secondary | General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later) | The treating physician used the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8(excellent). PGE will be completed before and approx. 6 weeks after treatment initiation. Count of patients with PGE score 2, 3, 4, 5, 6, 7, 8 are presented for Visit 1 and Visit 2. | FAS | Posted | Count of Participants | Participants | Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later) |
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| Secondary | Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction | A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied. Count of patients with divisions from very dissatisfied to very satisfied are presented. | FAS | Posted | Count of Participants | Participants | Visit 2 (approx. 6 weeks post baseline) |
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| Secondary | Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device | A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied. Count of patients with divisions from very dissatisfied to very satisfied are presented. | FAS | Posted | Count of Participants | Participants | Visit 2 (approx. 6 weeks post baseline) |
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| Secondary | Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device | A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied. Count of patients with divisions from very dissatisfied to very satisfied are presented. | FAS | Posted | Count of Participants | Participants | Visit 2 (approx. 6 weeks post baseline) |
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| 0 |
| 127 |
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| 127 |
| 0 |
| 127 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
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| Visit 2_score (3) |
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| Visit 1_score (4) |
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| Visit 2_score (4) |
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| Visit 1_score (5) |
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| Visit 2_score (5) |
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| Visit 1_score (6) |
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| Visit 2_score (6) |
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| Visit 1_score (7) |
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| Visit 2_score (7) |
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| Visit 1_score (8) |
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| Visit 2_score (8) |
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| Title | Measurements |
|---|---|
| 107 |
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| Neither satisfied nor dissatisfied |
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| Rather dissatisfied |
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| Dissatisfied |
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| Very dissatisfied |
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| Title | Measurements |
|---|---|
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| Neither satisfied nor dissatisfied |
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| Rather dissatisfied |
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| Dissatisfied |
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| Title | Measurements |
|---|---|
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| Neither satisfied nor dissatisfied |
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| Rather dissatisfied |
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| Dissatisfied |
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