Clinical trial NCT04657211: Triple Therapy in Chronic Obstructive Pulmonary Disease (COPD) Participants
Official title: Triple thErapy in paTients With COPD Under Real lIve Setting (the TETRIS Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
LABA
LAMA
ICS
TETRIS
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2020-12-08
Enrollment: 1213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study plans to recruit participants with moderate to severe COPD who have been on triple therapy for at least 6 and for a maximum of 18 weeks.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Participant is at least 18 years of age at the time of signing the informed consent.
* Participant is on a SITT or MITT for treatment of an obstructive respiratory disease for a period of 6 to 18 weeks prior enrolment with a combination of inhaled LAMA, LABA and ICS either on a triple maintenance treatment or an intermediate triple therapy regime (ICS "on/off" or LAMA "on/off").
* Inclusion criteria for Group A- (treatment by settled general practitioners): Participants are treated according to a physicians diagnosis of COPD.
* Inclusion criteria for Group B and C- (treatment by settled pulmonologists or treatment by outpatient lung centers): Participants have a confirmed physician's diagnosis (diagnosis based on spirometry or body plethysmography) of COPD.
* Participants need to give and be capable of giving signed informed consent form (ICF).

Exclusion Criteria:

* Participant has a diagnosis of pure asthma, without clinical features of COPD.
* Participant has a current diagnosis of lung cancer or lung metastasis.
* Participant has a current primary diagnosis of diffuse pan-bronchiolitis, or a primary diagnosis of bronchiectasis or pulmonary fibrosis or cystic fibrosis or other significant respiratory disorders.
* Participant is currently enrolled or has participated in a study within the last 90 days before signing of consent involving investigational study treatment intervention. If, while enrolled in the present study, the participant enrolls in another study involving investigational study treatment intervention, he/she will be withdrawn from the present study.
* Recent (\<= months) major cardiac or pulmonary event (for example myocardial infarction, pulmonary embolism).

Primary outcomes:
measure: Percentage of participants with COPD who continuously receive triple therapy
timeFrame: Up to 24 months
Secondary outcomes:
measure: Percentage of COPD participants with different profiles who are on triple therapy (LAMA/LABA/ICS)
timeFrame: Visit 1 at Day 1
measure: Percentage of COPD participants with combined treatable traits
timeFrame: Up to 24 months
measure: Percentage of participants with at least one switch from triple therapy to LAMA/LABA or to ICS/LABA
timeFrame: Up to 24 months
measure: Number of participants who initiated triple therapy as per decision of German physicians
timeFrame: Up to 24 months
measure: Number of participants who initiated on triple therapy by different clinical outcomes
timeFrame: Up to 24 months
measure: Number of COPD participants by healthcare resource utilization and the ongoing sequence of care events
timeFrame: Up to 24 months
measure: Number of participants with pneumonia and cardiovascular events as measure of safety
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: