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:
Study Type
OBSERVATIONAL
Enrollment
257
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.
Time frame: After approximately 6 weeks (visit 2)
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.
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 69 more locations
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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: After approx. 6 weeks (visit 2) of treatment initiation