TriOptimize: A prospective non-interventional Trial on COPD patients’ health related quality of life under a fixed LAMA/LABA/ICS triple therapy and characterization of determinants of treatment adherence

• Conditions: J44.9; J45; Chronic obstructive pulmonary disease, unspecified; Asthma

• Registration Number: DRKS00013938
• Lead Sponsor: Chiesi GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-04-06
• Study Start: 2021-12-28
• Results First Posted: 2022-12-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 2623

Inclusion Criteria

1) Patients with moderate to severe COPD (with and without asthma).
2) The doctor made the decision for a therapy with Trimbow® within the scope of its German approval, regardless of the present study.
3) Patients who have had at least one COPD exacerbation within the 12 months prior to starting treatment with Trimbow®.
4) Patients who are willing and able to give their written consent to the use of their pseudonymised personal data for the purposes of the present study.

Exclusion Criteria

1) Patients who were hospitalized for a COPD exacerbation within the last 4 weeks prior to inclusion.
2) Participation in a clinical trial within the last 30 days before inclusion in the present NIS.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary observation goal is to investigate the change in quality of life in COPD patients for whom the treating physician has decided to undergo therapy with Trimbow®.

Secondary Outcome Measures

Name	Time	Method
The secondary observation goal is to investigate adherence to COPD therapy, the reasons for non-adherence, the use of COPD reliever medication and the need to change COPD therapy before and during therapy with Trimbow®. Furthermore, changes in relevant lung function parameters as well as the retention of the Trimbow® treatment are to be examined.<br>Furthermore, the aim of this study is to collect as complete as possible patient data from routine care for the purpose of generating hypotheses at a later point in time.