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The purpose of the study is to measure changes in physical functioning in chronic obstructive pulmonary disease (COPD) patients being treated with Spiolto® Respimat® after approximately 6 weeks in routine clinical practice.
Purpose:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spiolto® Respimat® | consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spiolto® Respimat® | Drug | observations taken in a period of approximately 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2) | Therapeutic success defined as at least 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 ) and 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 sum of the scores of the 10 questions results 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 was standardized to a range of 0 to 100 using the following formula: [(sum of scale items - 10) * 100] / 20. Higher scores indicate better physical functioning. | after approximately 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Median Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 | The 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) and then the median for change from baseline values across all subjects was calculated. | Baseline (visit 1) and after approx. week 6 (visit 2) |
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Inclusion criteria:
Exclusion criteria:
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400 chronic obstructive pulmonary disease (COPD) patients will be enrolled in Pulmonology sites
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Generale Regionale "Miulli" | Acquaviva Delle Fonti (BA) | 70021 | Italy | |||
| Azienda Ospedaliera G. Rummo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32557394 | Derived | Carone M, Pennisi A, D'Amato M, Donati AF, Ricci A, Scognamillo C, Chun L, Aliani M, Ronsivalle V, Pelaia G. Physical Functioning in Patients with Chronic Obstructive Pulmonary Disease Treated with Tiotropium/Olodaterol Respimat in Routine Clinical Practice in Italy. Pulm Ther. 2020 Dec;6(2):261-274. doi: 10.1007/s41030-020-00122-9. Epub 2020 Jun 18. |
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All participants were screened for eligibility to participate in the study. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be entered if any one of the specific entry criteria were not met. Physical Functioning patient questionnaire (PF10)
Patient with chronic Obstructive Pulmonary Disease receiving treatment Spiolto® Respimat® were enrolled between July 2017 and May 2018.
309 screened and 3 patient violated inclusion/exclusion criteria were excluded, 306 entered the trial
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| ID | Title | Description |
|---|---|---|
| FG000 | Spiolto Respimat | Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 19, 2018 | Jul 29, 2019 |
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| Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | The patient's general condition was evaluated by means of Physician's Global Evaluation (PGE) score. The PGE score is documented on a scale from 1 (poor) to 8 (excellent) at both visits. 1-2: poor; 3-4: satisfactory; 5-6: good; 7-8: excellent | Baseline (visit 1) and after approx.week 6 (visit 2) |
| Patient Overall Satisfaction With Spiolto® Respimat® | Patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment at Week 6 (approx.) (Visit 2). | After approx. 6 weeks of treatment initiation |
| Patient Satisfaction With Inhaling From the Respimat® Device | Patients were asked how satisfied they were by inhaling with the Respimat® device at Week 6 (approx.) (Visit 2) | After approx. 6 weeks of treatment initiation |
| Patient Satisfaction With Handling of the Respimat® Inhalation Device | Patients were asked how satisfied they were with handling of the Respimat® inhalation device at Week 6 (approx.) (Visit 2). | After approx. 6 weeks of treatment initiation |
| Benevento |
| 82100 |
| Italy |
| Casa di cura Mons. Calaciura | Biancavilla | 95033 | Italy |
| Ospedale Orlandi | Bussolengo (VR) | 37012 | Italy |
| IRCCS - Istituto Scientifico di Cassano delle Murge | Cassano Murge Bari | 70020 | Italy |
| Università degli Studi "Magna Grecia" - Campus "S. Venuta" | Catanzaro | 88100 | Italy |
| Ospedale Mellino Mellini | Chiari (BS) | Italy |
| Osp. Piero Palagi | Florence | 50125 | Italy |
| Ospedale Colonnello D Avanzo | Foggia | 71100 | Italy |
| A.O. Ospedale Guido Salvini | Garbagnate Milanese | 20090 | Italy |
| Presidio Ospedaliero di Imperia - ASL 1 Imperiese | Imperia | 18100 | Italy |
| Ospedale della Versilia | LIDO DI Camaiore (LU) | 55043 | Italy |
| Ospedale S. Salvatore | L’Aquila | Italy |
| Osp.dell'Angelo | Mestre | 30171 | Italy |
| Fondazione Centro San Raffaele del Monte Tabor | Milan | 20132 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | 20162 | Italy |
| Osp. dei Colli Monaldi-Cotugno | Naples | 80131 | Italy |
| Azienda Sanitaria Ospedale S. Luigi Gonzaga | Orbassano | 10043 | Italy |
| Azienda Ospedaliera Universitaria di Padova | Padova | 35128 | Italy |
| Ospedale S.Maria della Misericordia, AO di Perugia | Perugia | 06156 | Italy |
| Azienda Ospedali Riuniti Marche Nord | Pesaro | 61100 | Italy |
| Az.per Assist. Sanitaria N.5 Friuli Occidentale | Pordenone | 33170 | Italy |
| Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza | Roma | 00189 | Italy |
| Università di Salerno | Salerno | 84121 | Italy |
| Presidio Ospedaliero di Sesto S. Giovanni ASST Nord Milano | Sesto San Giovanni (MI) | 20099 | Italy |
| Fondazione Salvatore Maugeri | Tradate (VA) | 21049 | Italy |
| Ospedale di Cattinara | Trieste | 34149 | Italy |
| Auxilium Vitae | Volterra | 56048 | Italy |
| COMPLETED |
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| NOT COMPLETED |
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Treated set (TS): The Treated set comprising all patients with informed consent, registration date and at least one documented administration of Spiolto® Respimat®.
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| ID | Title | Description |
|---|---|---|
| BG000 | Spiolto Respimat | Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) 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 | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | 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 | Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2) | Therapeutic success defined as at least 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 ) and 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 sum of the scores of the 10 questions results 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 was standardized to a range of 0 to 100 using the following formula: [(sum of scale items - 10) * 100] / 20. Higher scores indicate better physical functioning. | Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed PF-10 questionnaire at both study visits. | Posted | Number | 95% Confidence Interval | Percentage of Participants (%) | after approximately 6 weeks |
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| Secondary | The Median Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 | The 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) and then the median for change from baseline values across all subjects was calculated. | FAS | Posted | Median | Full Range | Unit on scale | Baseline (visit 1) and after approx. week 6 (visit 2) |
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| Secondary | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | The patient's general condition was evaluated by means of Physician's Global Evaluation (PGE) score. The PGE score is documented on a scale from 1 (poor) to 8 (excellent) at both visits. 1-2: poor; 3-4: satisfactory; 5-6: good; 7-8: excellent | FAS | Posted | Count of Participants | Participants | Baseline (visit 1) and after approx.week 6 (visit 2) |
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| Secondary | Patient Overall Satisfaction With Spiolto® Respimat® | Patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment at Week 6 (approx.) (Visit 2). | FAS | Posted | Count of Participants | Participants | After approx. 6 weeks of treatment initiation |
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| Secondary | Patient Satisfaction With Inhaling From the Respimat® Device | Patients were asked how satisfied they were by inhaling with the Respimat® device at Week 6 (approx.) (Visit 2) | FAS | Posted | Count of Participants | Participants | After approx. 6 weeks of treatment initiation |
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| Secondary | Patient Satisfaction With Handling of the Respimat® Inhalation Device | Patients were asked how satisfied they were with handling of the Respimat® inhalation device at Week 6 (approx.) (Visit 2). | FAS | Posted | Count of Participants | Participants | After approx. 6 weeks of treatment initiation |
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From first drug administration until end of study, up to approx 6 weeks.
All safety analyses were based on the TS
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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 | Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines | 1 | 306 | 2 | 306 | 0 | 306 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
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Therapeutic success was assessed by a patient questionnaire at two time points. The respective answers were dependent on the condition of the patient at the completion. No objective assessment was performed due to the non-interventional study concept
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 13, 2016 | Jul 29, 2019 | 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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