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
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 7443
- Primary Endpoint
- Percentage of Patients With Therapeutic Success After Approximately 6 Weeks.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Real-world data on the effects of a fixed-dose combination Long-acting beta agonists + long-acting antimuscarinic agent (LABA+LAMA) therapy with tiotropium and olodaterol administered in a single device, in COPD patients who need treatment with two long-acting bronchodilators, is not available. This is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto Respimat according to the approved Summary of Product Characteristics (SmPC).
Detailed Description
Purpose: Study Design:
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percentage of Patients With Therapeutic Success After Approximately 6 Weeks.
Time Frame: Approximately 6 weeks
The therapeutic success was defined as a minimum of 10- point increase in the Physical Functioning (PF-10) score between visit 1 (baseline visit at the start of the study) and visit 2 (final visit approximately 6 weeks after visit 1), having approximately time period of 6 weeks between the evaluated questionnaires. PF-10 score measures changes in physical functioning - serving as a surrogate for physical activity and exercise capacity - in COPD patients.
Secondary Outcomes
- Change in the Physical Functioning (PF-10) Score From Baseline (visit1) to Approximately 6 Weeks (visit2)(Baseline and week 6)
- General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2).(Baseline and week 6)
- Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)(Approximately 6 weeks)
- Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)(Approximately 6 weeks)
- Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)(Approximately 6 weeks)