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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

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 - TriOptimize

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00013938
Enrollment
2000
Registered
2021-12-28
Start date
2017-11-17
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J44.9 J45

Interventions

Group 1: COPD patients are asked about their quality of life using the CAT (COPD Assessment Test) questionnaire.

Sponsors

Chiesi GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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. 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.

Countries

Germany

Contacts

Public ContactValentina Bogoevska

CHIESI GmbH

v.bogoevska@chiesi.com+49 40 89724

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026