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
- 132
- Primary Endpoint
- Percentage of Patients With Therapeutic Success After Approximately (Approx.) 6 Weeks After Baseline
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
The primary objective of this Non Interventional Study is to measure changes in physical functioning, a surrogate for physical activity and exercise capacity, in COPD patients on treatment with Spiolto® Respimat® in routine daily treatment after approximately 6 weeks.
A secondary objective is to evaluate the patient's general condition (physician's evaluation) from Visit 1 (baseline visit at the start of the study) to 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 After Approximately (Approx.) 6 Weeks After Baseline
Time Frame: Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)
"Therapeutic success" is defined as a 10-point increase of physical functioning (PF)-10 between Visit 1 (baseline) and Visit 2 (approx. 6 weeks later) using a PF questionnaire, which is a subdomain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain 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 scores over the 10 questions will be summed, resulting 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 will be standardized to a range of 0 to 100 using the following formula: 100\*(sum-10)/20. Percentage of patients with therapeutic success after approximately 6 weeks after baseline are presented
Secondary Outcomes
- General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later)(Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later))
- Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 (Approx. 6 Weeks Later)(Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later))
- Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction(Visit 2 (approx. 6 weeks post baseline))
- Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device(Visit 2 (approx. 6 weeks post baseline))
- Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device(Visit 2 (approx. 6 weeks post baseline))