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
Overview
- Phase
- N/A
- Intervention
- Spiolto Respimat
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 1737
- Primary Endpoint
- Percentage of Patients With Therapeutic Success at Week 6 (Approx.) (Visit 2).
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The primary objective of the study is to measure changes in physical functioning - serving as a surrogate for physical activity and exercise capacity - in COPD patients being treated with Spiolto® Respimat® after approximately 6 weeks. A secondary objective is to evaluate the patient¿s general condition (physician¿s evaluation) at visit 1 (baseline visit at the start of the study) and at visit 2 (final visit at the end of the study, approx. 6 weeks after visit 1), as well as patient satisfaction with Spiolto® Respimat® at visit 2.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Spiolto Respimat
COPD patients requiring a fixed combination therapy of two long-acting bronchodilators (LAMA + LABA) according to approved Summary of Product Characteristics (SmPC) and Global Initiative for Chronic Obstructive Lung Disease (GOLD)guidelines
Intervention: Spiolto Respimat
Outcomes
Primary Outcomes
Percentage of Patients With Therapeutic Success at Week 6 (Approx.) (Visit 2).
Time Frame: after approximately 6 weeks
Therapeutic success defined as a minimum 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) quality of life questionnaire and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. The total score ranges from 0 to 100. A higher score indicates a better physical functioning.
Secondary Outcomes
- Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2).(Week 6 (approx.) (Visit 2))
- Changes in the PF-10 Score From Visit 1 to Visit 2(baseline and approx. week 6)
- General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2.(Baseline (Visit 1) and Week 6 (approx.) (Visit 2))
- Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2).(Week 6 (approx.) (Visit 2))
- Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2).(Week 6 (approx.) (Visit 2))