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This is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC. Patients will be enrolled consecutively and will be followed over an observational period of approx. 6 weeks.
Purpose:
Study Design:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spiolto Respimat | QOL measurement of COPD patients taking Spiolto Respimat |
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| 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 subdomain 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 (visit 2) |
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 | The change in Physical functioning questionnaire (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 mean for change from baseline values across all patients was calculated. The PF-10 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. |
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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 |
| Mireia Canals, +34607550925 | mireia.canals@boehringer-ingelheim.com | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Salud Águilas Sur | Aguilas (Murcia) | 30880 | Spain | |||
| Consultorio Médico de Albelda |
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All participants were screened for eligibility to participate in the study. Participants attended primary care centres 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.
Open-label observational study, including Chronic Obstructive Pulmonary Disease (COPD) patients in Spain receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations. Questionnaire (quest.).
10-point increase of Physical functioning questionnaire (PF10 )
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| ID | Title | Description |
|---|---|---|
| FG000 | Spiolto® Respimat® | Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium and olodaterol in a fixed dose combination through a single Respimat® inhalation 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 |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 13, 2016 | Sep 2, 2019 |
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| Baseline (visit 1) and after approx. week 6 (visit 2) |
| 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® at Visit 2 | A patient satisfaction questionnaire on how overall satisfied they were with the Spiolto® Respimat® treatment was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied). | After approx. 6 weeks (visit 2) of treatment initiation |
| Patient Satisfaction With Inhaling From the Respimat® Device | A patient satisfaction questionnaire on how satisfied they were by inhaling with the Respimat® device was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied). | After approx. 6 weeks (visit 2) of treatment initiation |
| Patient Satisfaction With Handling of the Respimat® Inhalation Device | A patient satisfaction questionnaire on how satisfied they were with handling of the Respimat® inhalation device was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied). | After approx. 6 weeks (visit 2) of treatment initiation |
| Albelda (Huesca) |
| 22558 |
| Spain |
| Centro de Salud Alcantarilla-Sangonera | Alcantarilla (Murcia) | 30820 | Spain |
| Centro de Salud Alquerías Raal | Alquerías (Murcia) | 30580 | Spain |
| Centro de Salud Aranda Norte | Aranda de Duero (Burgos) | 09400 | Spain |
| Centro de Salud Ávila Estación | Ávila | 05001 | Spain |
| Centro de Salud Ávila Rural | Ávila | 05003 | Spain |
| Centro de Salud Ávila Sureste | Ávila | 05003 | Spain |
| Centro de Salud Ávila Suroeste | Ávila | 05003 | Spain |
| Centro de Salud La Paz-Cruces | Barakaldo (Vizcaya) | 48903 | Spain |
| Consulta Privada | Barcelona | 8022 | Spain |
| Centro de Salud de Beniel | Beniel (Murcia) | 30130 | Spain |
| Zorroza Centro de Salud | Bilbao (Vizcaya) | 48002 | Spain |
| Centro de Salud Gazteleku | Bilbao (Vizcaya) | 48007 | Spain |
| Centro Médico IMQ | Bilbao (Vizcaya) | 48011 | Spain |
| Consulta Privada | Bizcaia | 20600 | Spain |
| Centro de Salud Bullas | Bullas (Murcia) | 30180 | Spain |
| Centro de Salud San Agustín | Burgos | 09001 | Spain |
| Centro de Salud Burgos Rural Norte | Burgos | 09006 | Spain |
| Centro de Salud Comuneros | Burgos | 09006 | Spain |
| Centro de Salud Las Torres | Burgos | 09006 | Spain |
| Centre d'Atenció Primària Calella | Calella (Barcelona) | 08370 | Spain |
| Centro de Salud Cartagena Este | Cartagena (Murcia) | 30203 | Spain |
| Centro de Salud Cartagena Oeste | Cartagena (Murcia) | 30205 | Spain |
| Centro de Salud del Barrio de Peral | Cartagena (Murcia) | 30300 | Spain |
| Centre d'Atenció Primària Centelles | Centelles (Barcelona) | 08540 | Spain |
| Centro de Salud de Torrekua | Eibar (Guipúzcoa) | 20600 | Spain |
| Centro de Salud Elgoibar | Elgoibar (Guipuzkoa) | 20870 | Spain |
| Centro de Salud Fuente Álamo | Fuente Álamo (Murcia) | 30320 | Spain |
| C.S. Guardo | Guardo (Palencia) | 34880 | Spain |
| Centro de Salud Sodupe | Güeñes (Vizcaya) | 48830 | Spain |
| Centro de Salud La Unión | La Unión (Murcia) | 30360 | Spain |
| Centro de Salud de Librilla | Librilla (Murcia) | 30892 | Spain |
| Centre d'Atenció Primària Lloret de Mar | Lloret de Mar (Girona) | 17310 | Spain |
| Centro de Salud Joaquín Elizalde | Logroño | 26004 | Spain |
| Centro de Salud Lorca Sur San José | Lorca (Murcia) | 30800 | Spain |
| Centro de Salud San Andrés | Madrid | 28021 | Spain |
| Centre Mèdic Bages | Manresa | 08243 | Spain |
| CS Medina del Campo | Medina del Campo | 47400 | Spain |
| Centro de Salud Medina del Campo Urbano | Medina Del Campo (Valladolid) | 47400 | Spain |
| Centro de Salud Miranda Oeste | Miranda de Ebro (Burgos) | 09200 | Spain |
| Centro de Salud Mula (Consultorio Albudeite) | Mula (Murcia) | 30170 | Spain |
| Consultorio Casillas | Murcia | 30007 | Spain |
| Centro de Salud Murcia Sur | Murcia | 30010 | Spain |
| Centro de Salud Murcia-Infante Juan Manuel | Murcia | 30011 | Spain |
| Centro de Salud Espinardo | Murcia | 30100 | Spain |
| Consultorio de Cobatillas | Murcia | 30163 | Spain |
| Centro de Salud Nájera | Nájera (La Rioja) | 26300 | Spain |
| Centro de Salud Oion | Oion (Álava) | 01320 | Spain |
| Consultorio Médico Palazuelos | Palazuelos de Eresma (Segovia) | 40194 | Spain |
| Centro de Salud Pintor Oliva | Palencia | 34004 | Spain |
| Centro Salud Peñaranda de Bracamonte | Peñaranda de Bracamonte (Salamanca) | 37300 | Spain |
| Centro de Salud Castaños | Portugalete (Vizcaya) | 48920 | Spain |
| Pozo Estrecho Centro de Salud | Pozo Estrecho (Murcia) | 30594 | Spain |
| Centro de Salud Quintanar de la Sierra | Quintanar de La Sierra (Burgos) | 09670 | Spain |
| Centro de Salud Universidad Centro de Salamanca | Salamanca | 37001 | Spain |
| Centro de Salud Garrido Sur | Salamanca | 37003 | Spain |
| San Bernado Oeste_Centro de Salud Miguel Armijo | Salamanca | 37007 | Spain |
| Centro de Salud Salvatierra | Salvatierra (Álava) | 1200 | Spain |
| Centro de Salud de Amara Centro | San Sebastián (Guipúzcoa) | 20006 | Spain |
| Centro de Saud Amara-Berri 20010 | San Sebastián (Guipúzcoa) | 20010 | Spain |
| Residencia Geriátrica Aldakonea | San Sebastián (Guipúzcoa) | 20012 | Spain |
| Centro de Salud Ambulatorio Gros | San Sebastián (Guipúzcoa) | 20013 | Spain |
| Centro de Salud Santomera | Santomera (Murcia) | 30140 | Spain |
| Centro de Salud Segovia I | Segovia | 40002 | Spain |
| Clínica Médica Goya | Segovia | 40002 | Spain |
| Centro de Salud Segovia II_ La Albuera | Segovia | 40004 | Spain |
| Centro de Salud Markonzaga | Sestao (Vizcaya) | 48910 | Spain |
| Centro de Salud Torre Pacheco | Torre Pacheco (Murcia) | 30700 | Spain |
| Centro de Salud Tudela de Duero | Tudela de Duero (Valladolid) | 47320 | Spain |
| Circunvalación Centro de Salud | Valladolid | 47012 | Spain |
| Centro de Salud Canterac | Valladolid | 47013 | Spain |
| Centro de Salud Casco Viejo | Vitoria (Álava) | 01001 | Spain |
| Centro Médico Medicentro | Vitoria (Álava) | 01001 | Spain |
| C.S. Aranbizkarra I | Vitoria (Álava) | 01002 | Spain |
| Policlínica San José | Vitoria (Álava) | 01008 | Spain |
| Centro de Salud Yecla Oeste | Yecla (Murcia) | 30510 | Spain |
| Centro de Salud Santa Elena | Zamora | 49007 | Spain |
| Centro de Salud Puerta Nueva | Zamora | 49016 | Spain |
| Treated |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Treated Set (TS): All screened patients with 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 and olodaterol in a fixed dose combination through a single Respimat® inhalation device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines |
| 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 |
| ||||||||||||||||||
| 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 subdomain 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): All screened patients with at least one documented administration of Spiolto® Respimat® and available PF-10 score at visit 1 and visit 2. | Posted | Number | 95% Confidence Interval | Percentage of Patients (%) | After approximately 6 weeks (visit 2) |
|
|
| |||||||||||||||||||||||||
| Secondary | The Mean Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 | The change in Physical functioning questionnaire (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 mean for change from baseline values across all patients was calculated. The PF-10 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. | FAS | Posted | Mean | Standard Deviation | Unit on scale | Baseline (visit 1) and after approx. week 6 (visit 2) |
| |||||||||||||||||||||||||||
| 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) |
|
| |||||||||||||||||||||||||||
| Secondary | Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2 | A patient satisfaction questionnaire on how overall satisfied they were with the Spiolto® Respimat® treatment was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied). | FAS who completed the questionnaire.14 patients with missing data were excluded from the analysis. | Posted | Count of Participants | Participants | After approx. 6 weeks (visit 2) of treatment initiation |
|
| |||||||||||||||||||||||||||
| Secondary | Patient Satisfaction With Inhaling From the Respimat® Device | A patient satisfaction questionnaire on how satisfied they were by inhaling with the Respimat® device was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied). | FAS | Posted | Count of Participants | Participants | After approx. 6 weeks (visit 2) of treatment initiation |
|
| |||||||||||||||||||||||||||
| Secondary | Patient Satisfaction With Handling of the Respimat® Inhalation Device | A patient satisfaction questionnaire on how satisfied they were with handling of the Respimat® inhalation device was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied). | FAS | Posted | Count of Participants | Participants | After approx. 6 weeks (visit 2) of treatment initiation |
|
|
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® | Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium and olodaterol in a fixed dose combination through a single Respimat® inhalation device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines | 1 | 253 | 1 | 253 | 0 | 253 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ischaemic stroke | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
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The interpretation of the results is limited by the lower number of patients recruited compared to what was planned. Results may not be representative of the Spanish COPD population.
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 | Feb 18, 2019 | Sep 2, 2019 | 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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