N/A
Completed N=306
Effectiveness and Handling of Spiolto® Respimat ® in COPD Patients - Italy
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT03003494 ↗
Enrolled (actual)
306
Serious AEs
0.7%
Results posted
Sep 2019
Primary outcomePrimary: Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2) — 52.52 Percentage of Participants (%)
Summary
The purpose of the study is to measure changes in physical functioning in chronic obstructive pulmonary disease (COPD) patients being treated with Spiolto® Respimat® after approximately 6 weeks in routine clinical practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2) |
52.52 | — |
| SECONDARY The Median Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 |
10 | — |
| SECONDARY Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 |
2; 5; 69; 72; 65; 46 | — |
| SECONDARY Patient Overall Satisfaction With Spiolto® Respimat® |
31; 111; 98; 29; 5; 0 | — |
| SECONDARY Patient Satisfaction With Inhaling From the Respimat® Device |
47; 119; 83; 23; 2; 1 | — |
| SECONDARY Patient Satisfaction With Handling of the Respimat® Inhalation Device |
57; 121; 70; 19; 4; 5 | — |
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 therapeutic plan recommendation
Exclusion criteria
- Patients with contraindications according to Spiolto® Respimat® Summary of Product Characteristics (SmPC)
- Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 months
- Patients continuing LABA-Inhalative Corticosteroids (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 (NCT03003494). 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.