OTIVACTO Spain Non Interventional Study
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT02927795
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Purpose:
Study Design:
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 257
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2) After approximately 6 weeks (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.
- Secondary Outcome Measures
Name Time Method Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Baseline (visit 1) and after approx.week 6 (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
Patient Satisfaction With Inhaling From the Respimat® Device After approx. 6 weeks (visit 2) of treatment initiation 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).
Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2 After approx. 6 weeks (visit 2) of treatment initiation 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).
The Mean Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 Baseline (visit 1) and after approx. week 6 (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.Patient Satisfaction With Handling of the Respimat® Inhalation Device After approx. 6 weeks (visit 2) of treatment initiation 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).
Trial Locations
- Locations (78)
Centre d'Atenció Primària Calella
🇪🇸Calella (Barcelona), Spain
Centro de Salud del Barrio de Peral
🇪🇸Cartagena (Murcia), Spain
Centro de Salud de Torrekua
🇪🇸Eibar (Guipúzcoa), Spain
C.S. Guardo
🇪🇸Guardo (Palencia), Spain
Centro de Salud Elgoibar
🇪🇸Elgoibar (Guipuzkoa), Spain
Consultorio de Cobatillas
🇪🇸Murcia, Spain
Centro de Salud Pintor Oliva
🇪🇸Palencia, Spain
Centre d'Atenció Primària Centelles
🇪🇸Centelles (Barcelona), Spain
Centro Salud Peñaranda de Bracamonte
🇪🇸Peñaranda De Bracamonte (Salamanca), Spain
Centro de Salud Cartagena Oeste
🇪🇸Cartagena (Murcia), Spain
Centro de Salud Fuente Álamo
🇪🇸Fuente Álamo (Murcia), Spain
Centro de Salud Sodupe
🇪🇸Güeñes (Vizcaya), Spain
Centro de Salud de Librilla
🇪🇸Librilla (Murcia), Spain
Centro de Salud La Unión
🇪🇸La Unión (Murcia), Spain
Centro de Salud Joaquín Elizalde
🇪🇸Logroño, Spain
Centro de Salud Nájera
🇪🇸Nájera (La Rioja), Spain
Centro de Salud Salvatierra
🇪🇸Salvatierra (Álava), Spain
Centro de Salud Segovia II_ La Albuera
🇪🇸Segovia, Spain
Centro de Salud Cartagena Este
🇪🇸Cartagena (Murcia), Spain
Centro de Salud Lorca Sur San José
🇪🇸Lorca (Murcia), Spain
Centro de Salud Miranda Oeste
🇪🇸Miranda De Ebro (Burgos), Spain
C.S. Aranbizkarra I
🇪🇸Vitoria (Álava), Spain
Centro de Salud Santa Elena
🇪🇸Zamora, Spain
Centro de Salud Oion
🇪🇸Oion (Álava), Spain
Centro de Salud Espinardo
🇪🇸Murcia, Spain
Consultorio Médico Palazuelos
🇪🇸Palazuelos De Eresma (Segovia), Spain
Centro de Salud Markonzaga
🇪🇸Sestao (Vizcaya), Spain
Centro de Salud Ávila Suroeste
🇪🇸Ávila, Spain
Centro de Salud Universidad Centro de Salamanca
🇪🇸Salamanca, Spain
Centre d'Atenció Primària Lloret de Mar
🇪🇸Lloret De Mar (Girona), Spain
Centre Mèdic Bages
🇪🇸Manresa, Spain
Centro de Salud San Andrés
🇪🇸Madrid, Spain
Centro de Salud Medina del Campo Urbano
🇪🇸Medina Del Campo (Valladolid), Spain
CS Medina del Campo
🇪🇸Medina del Campo, Spain
Consultorio Casillas
🇪🇸Murcia, Spain
Centro de Salud Mula (Consultorio Albudeite)
🇪🇸Mula (Murcia), Spain
Centro de Salud Castaños
🇪🇸Portugalete (Vizcaya), Spain
Centro de Salud Quintanar de la Sierra
🇪🇸Quintanar De La Sierra (Burgos), Spain
Centro de Salud Murcia Sur
🇪🇸Murcia, Spain
Centro de Salud Murcia-Infante Juan Manuel
🇪🇸Murcia, Spain
Centro de Saud Amara-Berri 20010
🇪🇸San Sebastián (Guipúzcoa), Spain
Centro de Salud Santomera
🇪🇸Santomera (Murcia), Spain
Centro de Salud Segovia I
🇪🇸Segovia, Spain
Centro de Salud Casco Viejo
🇪🇸Vitoria (Álava), Spain
Centro Médico Medicentro
🇪🇸Vitoria (Álava), Spain
Policlínica San José
🇪🇸Vitoria (Álava), Spain
Centro de Salud Yecla Oeste
🇪🇸Yecla (Murcia), Spain
Centro de Salud Puerta Nueva
🇪🇸Zamora, Spain
Centro de Salud Ávila Estación
🇪🇸Ávila, Spain
Centro de Salud Ávila Rural
🇪🇸Ávila, Spain
Centro de Salud Ávila Sureste
🇪🇸Ávila, Spain
Centro de Salud Águilas Sur
🇪🇸Aguilas (Murcia), Spain
Centro de Salud Alquerías Raal
🇪🇸Alquerías (Murcia), Spain
Consultorio Médico de Albelda
🇪🇸Albelda (Huesca), Spain
Centro de Salud Alcantarilla-Sangonera
🇪🇸Alcantarilla (Murcia), Spain
Centro de Salud Aranda Norte
🇪🇸Aranda De Duero (Burgos), Spain
Centro de Salud La Paz-Cruces
🇪🇸Barakaldo (Vizcaya), Spain
Consulta Privada
🇪🇸Bizcaia, Spain
Zorroza Centro de Salud
🇪🇸Bilbao (Vizcaya), Spain
Centro de Salud de Beniel
🇪🇸Beniel (Murcia), Spain
Centro de Salud Gazteleku
🇪🇸Bilbao (Vizcaya), Spain
Centro de Salud Bullas
🇪🇸Bullas (Murcia), Spain
Centro Médico IMQ
🇪🇸Bilbao (Vizcaya), Spain
Centro de Salud San Agustín
🇪🇸Burgos, Spain
Centro de Salud Burgos Rural Norte
🇪🇸Burgos, Spain
Centro de Salud Comuneros
🇪🇸Burgos, Spain
Centro de Salud Las Torres
🇪🇸Burgos, Spain
Pozo Estrecho Centro de Salud
🇪🇸Pozo Estrecho (Murcia), Spain
Centro de Salud Garrido Sur
🇪🇸Salamanca, Spain
San Bernado Oeste_Centro de Salud Miguel Armijo
🇪🇸Salamanca, Spain
Centro de Salud de Amara Centro
🇪🇸San Sebastián (Guipúzcoa), Spain
Residencia Geriátrica Aldakonea
🇪🇸San Sebastián (Guipúzcoa), Spain
Centro de Salud Ambulatorio Gros
🇪🇸San Sebastián (Guipúzcoa), Spain
Clínica Médica Goya
🇪🇸Segovia, Spain
Centro de Salud Canterac
🇪🇸Valladolid, Spain
Centro de Salud Tudela de Duero
🇪🇸Tudela De Duero (Valladolid), Spain
Centro de Salud Torre Pacheco
🇪🇸Torre Pacheco (Murcia), Spain
Circunvalación Centro de Salud
🇪🇸Valladolid, Spain