N/A
Completed N=1,737
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
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT02675517 ↗
Enrolled (actual)
1,737
Serious AEs
0.2%
Results posted
Oct 2018
Primary outcomePrimary: Percentage of Patients With Therapeutic Success at Week 6 (Approx.) (Visit 2). — 51.52 Percentage of patients
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Therapeutic Success at Week 6 (Approx.) (Visit 2). |
51.52 | — |
| SECONDARY Changes in the PF-10 Score From Visit 1 to Visit 2 |
11.63 | — |
| SECONDARY General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. |
1.20; 11.28; 22.69; 30.04; 18.82; 11.91 | — |
| SECONDARY Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2). |
33.59; 48.86; 8.11; 3.99; 2.09; 2.66 | — |
| SECONDARY Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2). |
35.17; 52.34; 6.91; 3.49; 0.89; 0.76 | — |
| SECONDARY Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2). |
33.08; 52.09; 9.82; 2.98; 0.82; 0.82 | — |
Eligibility Criteria
Inclusion criteria
- Written informed consent prior to participation
- Female and male patients = 40 years of age
- Patients diagnosed with COPD and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto® Respimat® SmPC and COPD GOLD guideline recommendation
Exclusion criteria
- Patients with contraindications according to Spiolto® Respimat® SmPC
- Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 months
- Patients continuing LABA- Inhalative Corticosteroides (iCS)treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists
- Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks
- Pregnancy and lactation
- Patients currently listed for lung transplantation
- Current participation in any clinical trial or any other non-interventional study of a drug or device
Data sourced from ClinicalTrials.gov (NCT02675517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.