N/A
Completed N=1,359
Greek NIS Spiolto ELLACTO
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT03419962 ↗
Enrolled (actual)
1,359
Serious AEs
0.1%
Results posted
Apr 2020
Primary outcomePrimary: Percentage of Patients Achieving "Therapeutic Success" Defined as a ≥ 0.4 Point of Decrease in the Clinical COPD Questionnaire (CCQ) Score — 64.3 Percentage of participants
Summary
Open-label observational study: including COPD patients receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Achieving "Therapeutic Success" Defined as a ≥ 0.4 Point of Decrease in the Clinical COPD Questionnaire (CCQ) Score |
64.3 | — |
| SECONDARY Absolute Change in Clinical COPD Questionnaire (CCQ) Score Between Visit 1 and Visit 2 |
-0.63 | — |
| SECONDARY Absolute Change in the Functional Status Subdomain of Clinical COPD Questionnaire (CCQ-4) Score Between Visit 1 and Visit 2 |
-0.59 | — |
| SECONDARY General Condition of Patient at Visit 1 and Visit 2 |
153; 496; 568; 115; 0; 38 | — |
| SECONDARY Patients Satisfaction With Spiolto® Respimat® at Visit 2 |
2; 7; 7; 99; 184; 600 | — |
| SECONDARY Patients Preference for Spiolto® Respimat® at Visit 2 |
17; 217; 20 | — |
| SECONDARY Patient's Willingness to Continue Treatment With Spiolto® Respimat® at Visit 2 |
32.3; 79.8 | — |
Eligibility Criteria
Inclusion Criteria
- Therapeutic indication before entering the enrollment face is patients diagnosed with COPD requiring a combination therapy of two long-acting bronchodilators (LAMA + LABA) according to approved SmPC and guidelines, COPD GOLD 2017 groups B to D
- Female and male patients ≥40 years of age
- Treatment with Spiolto ® Respimat® acc. to SmPC and at the discretion of the physician
- Written informed consent prior to participation
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 weeks or patients already on a combination of LAMA and LABA therapy; either as a fixed combination product or as separate components Note: Patients previously treated with LABA or LAMA (with or without ICS) are eligible to be included in the study
- Patients continuing LABA-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 (NCT03419962). 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.