Last updated: 08/04/2025 14:00:44
Triple therapy in chronic obstructive pulmonary disease (COPD) participantsTETRIS
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Triple thErapy in paTients with COPD under Real lIve Setting (the TETRIS study)
Trial description: 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).
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Percentage of participants with COPD who continuously receive triple therapy
Timeframe: Up to 24 months
Secondary outcomes:
Percentage of COPD participants with different profiles who are on triple therapy (LAMA/LABA/ICS)
Timeframe: Visit 1 at Day 1
Percentage of COPD participants with combined treatable traits
Timeframe: Up to 24 months
Percentage of participants with at least one switch from triple therapy to LAMA/LABA or to ICS/LABA
Timeframe: Up to 24 months
Number of participants who initiated triple therapy as per decision of German physicians
Timeframe: Up to 24 months
Number of participants who initiated on triple therapy by different clinical outcomes
Timeframe: Up to 24 months
Number of COPD participants by healthcare resource utilization and the ongoing sequence of care events
Timeframe: Up to 24 months
Number of participants with pneumonia and cardiovascular events as measure of safety
Timeframe: Up to 24 months
Interventions:
Enrollment:
1212
Primary completion date:
2024-01-07
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
January 2021 to July 2024
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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”).
- Participant has a diagnosis of pure asthma, without clinical features of COPD.
- Participant has a current diagnosis of lung cancer or lung metastasis.
Inclusion and exclusion 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).
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
No study documents available
Recruitment status
Study complete
Actual primary completion date
2024-01-07
Actual study completion date
2024-01-07
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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