NCT04657211

Triple Therapy in Chronic Obstructive Pulmonary Disease (COPD) Participants

Triple thErapy in paTients With COPD Under Real lIve Setting (the TETRIS Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,212 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

TETRIS is a multi-center, prospective observational cohort study. It will include participants with COPD who are on an existing combined treatment of long-acting muscarinic antagonist (LAMA), long-acting beta 2 agonists (LABA) and inhaled corticosteroids (ICS).

Detailed description

COPD is a disabling respiratory disease characterized by airflow obstruction and associated symptoms, including breathing difficulties caused by shortness of breath and wheezing, airway hyperactivity, chronic cough, sputum production, exercise intolerance, and poor quality of life. In accordance with the GOLD (Global Initiative for Chronic Obstructive Lung Disease) recommendations, it is important to assess the characteristics and treatment patterns of participants prior to triple therapy initiation, in order to determine adherence to these guidelines and understand how participants progress to triple therapy. Despite a clearly defined guidance from GOLD treatment recommendations for the initiation and maintenance of triple therapy, treatment changes in Germany, including de-escalation, are often seen in treatment reality. This study is intended to gain a better understanding of what influences the treatment decision of German physicians in primary and secondary care under real life conditions, to elicit the reasons for treatment changes and to describe long-term outcomes with participants initiated on triple therapy over a period of two years. This study will also describe the temporal dynamics of treatment pattern and to unravel potentially complex participant's journeys in different German regions and also to identify and follow-up a variety of 'treatable traits' in COPD participants, which when modified may lead to improved health outcomes.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
OTHER	Prospective observational cohort study	prospective observational cohort study

Timeline

• Start date: 2021-01-14
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2020-12-08
• Last updated: 2025-08-17
• Results posted: 2025-08-17

Locations

1 site across 1 country: Germany