Triple Therapy in Chronic Obstructive Pulmonary Disease (COPD) Participants

Pulmonary Disease, Chronic Obstructive Clinical Trial

— TETRIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04657211
• Other study ID #: 214468
• Status: Recruiting
• Start date: January 14, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: June 2022
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2050
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• prospective observational cohort study
prospective observational cohort study

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Hannover	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with COPD who continuously receive triple therapy	Participants with COPD who continuously receive triple therapy will be evaluated.; The participant should be on a single inhaler triple therapy (SITT) or multiple inhaler triple therapy (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").	Up to 24 months
Secondary	Percentage of COPD participants with different profiles who are on triple therapy (LAMA/LABA/ICS)	Percentage of participants with different profiles will be summarized which will include asthma at the age of less than (<) 40 years, peripheral blood eosinophils (EOS) of <100 cells per microliter (/µl), 100-200 cells/µl, 200-300 cells/µl and more than (>) 300 cells/µl, physician's diagnosis of COPD by site localization and physician´s group, participants who meet GOLD definition of COPD, and medications received by COPD participants (including Oral Corticosteroids [OCS]), split by physician group and site localization.	Visit 1 at Day 1
Secondary	Percentage of COPD participants with combined treatable traits	Percentage of participants with combined treatable traits will be summarized which will include smoking and non-smoking history when initiating triple therapy; forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) ratio <0.7; at least one event of unstable COPD, cold requiring antibiotics or exacerbation; COPD Assessment Test(CAT) score less than or equal to (>=)10; peripheral blood EOS count >=100 cells/µl; emphysematous versus chronic bronchitis phenotype; and physical activity level in participants over a 24 months observation period.	Up to 24 months
Secondary	Percentage of participants with at least one switch from triple therapy to LAMA/LABA or to ICS/LABA	Participants with at least one switch from triple therapy to LAMA/LABA or to ICS/LABA will be evaluated.	Up to 24 months
Secondary	Number of participants who initiated triple therapy as per decision of German physicians	Participants who initiated triple therapy as per decision of German physicians with pre-specified reason to initiate triple therapy will be summarized.	Up to 24 months
Secondary	Number of participants who initiated on triple therapy by different clinical outcomes	Clinical outcomes will include mean annual rate of moderate and/or severe exacerbations, mean annual rate of hospitalizations due to severe exacerbations, change of lung function parameters, change of COPD symptoms, change in health-related quality of life (HRQoL), clinically important deterioration, time to first event, time to first moderate or severe exacerbation, time to first hospitalization/intensive care unit admission, and time to death.	Up to 24 months
Secondary	Number of COPD participants by healthcare resource utilization and the ongoing sequence of care events	Participant's journey will be summarized which will include the ongoing sequence of care events which a participant follows from the point of access into the health system, continuing towards diagnosis and care and ending in outpatient care.	Up to 24 months
Secondary	Number of participants with pneumonia and cardiovascular events as measure of safety	Number of participants with pneumonia and cardiovascular events will be evaluated along with benefit-harm profiles for the triple therapy.	Up to 24 months