A prospective non-interventional study to assess quality of life and COPDsymptoms in patients with COPD on LAMA/LABA/ICS triple therapy withElebrato® Ellipta®

• Conditions: J44.9; Chronic obstructive pulmonary disease, unspecified

• Registration Number: DRKS00031897
• Lead Sponsor: BERLIN-CHEMIE AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-07-28
• Study Start: 2023-05-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 931

Inclusion Criteria

1. Patients =18 years, with moderate to severe COPD (FEV1 =30% - <80%)
2. Decision for the therapy with Elebrato Ellipta was made in accordance with the current registration and independently from the participation in this NIS,
3. Patients with at least one COPD exacerbation within the last 12 months prior to starting treatment with Elebrato Ellipta,
4. Patients with a CAT = 10 prior to starting treatment with Elebrato Ellipta,
5. Patient treated with Elebrato Ellipta for the first time; this includes patients already on Elebrato Ellipta for a maximum of 4 weeks prior to enrolment into
this NIS, and whose COPD medication was not changed during this period,
6. Patients who are willing and able to give their written consent to the use of their pseudonymized personal information for the purposes of this study.

Exclusion Criteria

1. Patients hospitalized due to COPD exacerbation within the last 4 weeks prior to enrolment,
2. Participation in a clinical trial within the last 30 days prior to inclusion in this NIS,
3. Any contraindication as per the SmPC of Elebrato Ellipta.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the total COPD Assessment Test (CAT) score between<br>baseline and month 12.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes include the change in the total CAT score after 3, 6, and 9 months, number and severity of exacerbations within 12 months as well as the time to first exacerbation. <br>Furthermore, changes in eosinophils, spirometry parameters and therapy adherence will be assessed. Changes in physical performance tests, use of TheraKey® COPD and use of rescue medication will be determined. Incidence and type of adverse events will be further documented.