Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Assessment of Physical Functioning and Handling of Spiolto® Respimat® in Patients With Chronic Obstructive Pulmonary Disease (COPD) Requiring Long-acting Dual Bronchodilation in Routine Clinical Practice
| NCT number | NCT02927795 |
| Other study ID # | 1237.58 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 26, 2017 |
| Est. completion date | September 18, 2018 |
| Verified date | September 2019 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 257 |
| Est. completion date | September 18, 2018 |
| Est. primary completion date | September 18, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years and older |
| Eligibility |
Inclusion criteria: 1. Written informed consent prior to participation 2. Female and male patients = or > 40 years of age 3. Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and requiring long-acting dual bronchodilation (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 agonist (LABA)) treatment according to approved Spiolto® Respimat® Summary of Product Characteristics (SmPC) and COPD Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline recommendation Exclusion criteria: 1. Patients with contraindications according to Spiolto® Respimat® SmPC 2. Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 months 3. Patients continuing Long-acting beta2 agonist and inhalative corticosteroids (LABA-iCS) treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta2 agonists 4. Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks 5. Pregnancy and lactation 6. Patients currently listed for lung transplantation 7. Current participation in any clinical trial or any other non-interventional study of a drug or device |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Centro de Salud Águilas Sur | Aguilas (Murcia) | |
| Spain | Consultorio Médico de Albelda | Albelda (Huesca) | |
| Spain | Centro de Salud Alcantarilla-Sangonera | Alcantarilla (Murcia) | |
| Spain | Centro de Salud Alquerías Raal | Alquerías (Murcia) | |
| Spain | Centro de Salud Aranda Norte | Aranda De Duero (Burgos) | |
| 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 Ávila Suroeste | Ávila | |
| Spain | Centro de Salud La Paz-Cruces | Barakaldo (Vizcaya) | |
| Spain | Consulta Privada | Barcelona | |
| Spain | Centro de Salud de Beniel | Beniel (Murcia) | |
| Spain | Centro de Salud Gazteleku | Bilbao (Vizcaya) | |
| Spain | Centro Médico IMQ | Bilbao (Vizcaya) | |
| Spain | Zorroza Centro de Salud | Bilbao (Vizcaya) | |
| Spain | Consulta Privada | Bizcaia | |
| Spain | Centro de Salud Bullas | Bullas (Murcia) | |
| Spain | Centro de Salud Burgos Rural Norte | Burgos | |
| Spain | Centro de Salud Comuneros | Burgos | |
| Spain | Centro de Salud Las Torres | Burgos | |
| Spain | Centro de Salud San Agustín | Burgos | |
| Spain | Centre d'Atenció Primària Calella | Calella (Barcelona) | |
| Spain | Centro de Salud Cartagena Este | Cartagena (Murcia) | |
| Spain | Centro de Salud Cartagena Oeste | Cartagena (Murcia) | |
| Spain | Centro de Salud del Barrio de Peral | Cartagena (Murcia) | |
| Spain | Centre d'Atenció Primària Centelles | Centelles (Barcelona) | |
| Spain | Centro de Salud de Torrekua | Eibar (Guipúzcoa) | |
| Spain | Centro de Salud Elgoibar | Elgoibar (Guipuzkoa) | |
| Spain | Centro de Salud Fuente Álamo | Fuente Álamo (Murcia) | |
| Spain | C.S. Guardo | Guardo (Palencia) | |
| Spain | Centro de Salud Sodupe | Güeñes (Vizcaya) | |
| Spain | Centro de Salud La Unión | La Unión (Murcia) | |
| Spain | Centro de Salud de Librilla | Librilla (Murcia) | |
| Spain | Centre d'Atenció Primària Lloret de Mar | Lloret De Mar (Girona) | |
| Spain | Centro de Salud Joaquín Elizalde | Logroño | |
| Spain | Centro de Salud Lorca Sur San José | Lorca (Murcia) | |
| Spain | Centro de Salud San Andrés | Madrid | |
| Spain | Centre Mèdic Bages | Manresa | |
| Spain | CS Medina del Campo | Medina del Campo | |
| Spain | Centro de Salud Medina del Campo Urbano | Medina Del Campo (Valladolid) | |
| Spain | Centro de Salud Miranda Oeste | Miranda De Ebro (Burgos) | |
| Spain | Centro de Salud Mula (Consultorio Albudeite) | Mula (Murcia) | |
| Spain | Centro de Salud Espinardo | Murcia | |
| Spain | Centro de Salud Murcia Sur | Murcia | |
| Spain | Centro de Salud Murcia-Infante Juan Manuel | Murcia | |
| Spain | Consultorio Casillas | Murcia | |
| Spain | Consultorio de Cobatillas | Murcia | |
| Spain | Centro de Salud Nájera | Nájera (La Rioja) | |
| Spain | Centro de Salud Oion | Oion (Álava) | |
| Spain | Consultorio Médico Palazuelos | Palazuelos De Eresma (Segovia) | |
| Spain | Centro de Salud Pintor Oliva | Palencia | |
| Spain | Centro Salud Peñaranda de Bracamonte | Peñaranda De Bracamonte (Salamanca) | |
| Spain | Centro de Salud Castaños | Portugalete (Vizcaya) | |
| Spain | Pozo Estrecho Centro de Salud | Pozo Estrecho (Murcia) | |
| Spain | Centro de Salud Quintanar de la Sierra | Quintanar De La Sierra (Burgos) | |
| Spain | Centro de Salud Garrido Sur | Salamanca | |
| Spain | Centro de Salud Universidad Centro de Salamanca | Salamanca | |
| Spain | San Bernado Oeste_Centro de Salud Miguel Armijo | Salamanca | |
| Spain | Centro de Salud Salvatierra | Salvatierra (Álava) | |
| Spain | Centro de Salud Ambulatorio Gros | San Sebastián (Guipúzcoa) | |
| Spain | Centro de Salud de Amara Centro | San Sebastián (Guipúzcoa) | |
| Spain | Centro de Saud Amara-Berri 20010 | San Sebastián (Guipúzcoa) | |
| Spain | Residencia Geriátrica Aldakonea | San Sebastián (Guipúzcoa) | |
| Spain | Centro de Salud Santomera | Santomera (Murcia) | |
| Spain | Centro de Salud Segovia I | Segovia | |
| Spain | Centro de Salud Segovia II_ La Albuera | Segovia | |
| Spain | Clínica Médica Goya | Segovia | |
| Spain | Centro de Salud Markonzaga | Sestao (Vizcaya) | |
| Spain | Centro de Salud Torre Pacheco | Torre Pacheco (Murcia) | |
| Spain | Centro de Salud Tudela de Duero | Tudela De Duero (Valladolid) | |
| Spain | Centro de Salud Canterac | Valladolid | |
| Spain | Circunvalación Centro de Salud | Valladolid | |
| Spain | C.S. Aranbizkarra I | Vitoria (Álava) | |
| 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 Santa Elena | Zamora |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. |
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. |
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 | 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). | 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). | 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). | After approx. 6 weeks (visit 2) of treatment initiation |
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