Trial results for an observational study on triple therapy adherence in Chronic Obstructive Pulmonary Disease (COPD) participants were posted on ClinicalTrials.gov on 2025-08-17, revealing that 38.5% of participants continuously received triple therapy for 24 months.
Background
Chronic Obstructive Pulmonary Disease (COPD) is a progressive lung disease that causes obstructed airflow from the lungs. It is a major cause of morbidity and mortality worldwide. For many patients, a combination of a long-acting muscarinic antagonist (LAMA), a long-acting beta 2 agonist (LABA), and an inhaled corticosteroid (ICS) is prescribed as triple therapy to manage symptoms and reduce exacerbations. Understanding adherence to this complex regimen is critical for optimizing patient outcomes and informing clinical practice.
Trial design
The TETRIS study (NCT04657211) was a completed multi-center, prospective observational cohort study that enrolled 1212 participants with Pulmonary Disease, Chronic Obstructive. The study focused on participants already receiving combined triple therapy (long-acting muscarinic antagonist, long-acting beta 2 agonists, and inhaled corticosteroids). As an observational study, it did not have defined phases or comparator arms, but aimed to describe real-world adherence patterns to triple therapy.
Key results
The study reported several key measurements regarding triple therapy adherence and participant characteristics:
- The percentage of participants who continuously received triple therapy for 6 months was 92.5%.
- For 12 months, this percentage was 84.4%.
- By 24 months, the percentage of participants continuously on triple therapy was 38.5%.
- The median time to stop triple therapy was 719 days.
- Regarding baseline characteristics, 12.5% of participants had a diagnosis of asthma at the age of less than 40 years.
- Peripheral blood eosinophil (EOS) counts at baseline showed the following distribution: 23.4% of participants had counts less than 100 cells/uL, 26.6% had 100 to less than 200 cells/uL, 19.1% had 200 to less than 300 cells/uL, and 30.9% had counts greater than or equal to 300 cells/uL.
- Physician's diagnosis of COPD by site localization was reported as 23.7%, 16.1%, and 16.1% for different localizations.
What this means
The results of this observational study highlight the real-world adherence patterns to triple therapy in COPD patients. While initial adherence is high, with over 84% maintaining treatment at 12 months, there is a notable decline by 24 months, where less than 40% continue therapy. The median time to discontinuation of 719 days (approximately 2 years) suggests that a significant proportion of patients stop treatment within this timeframe. These findings underscore the importance of strategies to support long-term adherence to complex treatment regimens in COPD, which could involve patient education, simplified dosing, or closer monitoring. The baseline demographic data, including asthma diagnosis and eosinophil counts, may also inform future research into factors influencing adherence.
Source
The information for this condition update was sourced from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04657211, titled "Triple Therapy in Chronic Obstructive Pulmonary Disease (COPD) Participants", were posted on 2025-08-17 on clinicaltrials.gov.