N/A
Completed N=1,212
Triple Therapy in Chronic Obstructive Pulmonary Disease (COPD) Participants
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT04657211 ↗
Enrolled (actual)
1,212
Serious AEs
11.9%
Results posted
Aug 2025
Primary outcomePrimary: Percentage of Participants Who Continuously Received Triple Therapy for 6 Months — 92.5 Percentage of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Continuously Received Triple Therapy for 6 Months |
92.5 | — |
| PRIMARY Percentage of Participants Who Continuously Received Triple Therapy for 12 Months |
84.4 | — |
| PRIMARY Percentage of Participants Who Continuously Received Triple Therapy for 24 Months |
38.5 | — |
| PRIMARY Time to Stop Triple Therapy |
719 | — |
| SECONDARY Percentage of Participants With Diagnosis of Asthma at the Age of <40 Years |
12.5 | — |
| SECONDARY Percentage of Participants With Peripheral Blood Eosinophils (EOS) Count <100 Cells/uL, 100 to <200 Cells/uL, 200 to <300 Cells/uL and >=300 Cells/uL at Baseline |
23.4; 26.6; 19.1; 30.9 | — |
| SECONDARY Percentage of Participants With a Physician's Diagnosis of COPD by Site Localization |
23.7; 16.1; 16.1; 44.1 | — |
| SECONDARY Percentage of Participants With a Physician's Diagnosis of COPD by Physicians Group |
38.9; 61.1 | — |
| SECONDARY Percentage of Participants With COPD Symptom and Risk Classes (GOLD 1 to 4) at Baseline |
7.4; 38.0; 28.0; 7.3; 19.3 | — |
| SECONDARY Percentage of Participants With COPD Symptom and Risk Classes (GOLD A to D) at Baseline |
13.6; 43.9; 13.4; 12.6; 16.5 | — |
| SECONDARY Percentage of Participants Who Received Concomitant Respiratory Medication at Months 6, 12 and 24 |
2.6; 1.1; 23.4; 0.2; 1.1; 71.6 | — |
| SECONDARY Percentage of Participants by Their Duration of Triple Therapy Before Study Start |
31.9; 27.6; 40.5 | — |
| SECONDARY Percentage of Participants by Their Smoking Status at Months 6, 12 and 24 |
8.8; 37.0; 54.2; 8.8; 36.8; 54.3 | — |
| SECONDARY Percentage of Participants With a Lifelong Non-smoking History at Baseline |
8.9 | — |
| SECONDARY Percentage of Participants With Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) Ratio (FEV1/FVC) of <0.7 at Study Enrollment and at 6, 12 and 24 Months |
50.4; 41.5; 42.8; 42.4 | — |
| SECONDARY Percentage of Participants With Any Moderate/Severe Exacerbation in the 24 Months Prior to Baseline or 3 Months Prior to Each Subsequent On-study Visits at Months 6, 12 and 24 |
5.1; 5.6; 8.5; 6.8 | — |
| SECONDARY Percentage of Participants With a COPD Assessment Test (CAT) Score <=10, 11-19, >=20 at Baseline and at 6, 12 and 24 Months Documentation |
10.7; 37.8; 51.6; 14.5; 48.5; 36.9 | — |
| SECONDARY Percentage of Participants With Peripheral Blood EOS Count of <300 and >=300 Cells/uL at 6, 12 and 24 Months |
3.8; 1.2; 95.0; 3.5; 1.9; 94.6 | — |
| SECONDARY Percentage of Participants With Chronic Bronchitis Phenotype |
75.5 | — |
| SECONDARY Percentage of Participants With at Least One Switch From Triple Therapy to Long-acting Muscarinic Antagonist (LAMA)/Long-acting Beta Agonist (LABA) From Months 6 to 24 |
2.2 | — |
| SECONDARY Percentage of Participants With at Least One Switch From Triple Therapy to Inhaled Corticosteroids (ICS)/LABA From Months 6 to 24 |
1.5 | — |
| SECONDARY Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group |
23.4; 52.4; 32.4; 15.1; 6.7; 3.0 | — |
| SECONDARY Percentage of Participants With Change From Triple to Dual Therapy and Back to Triple Therapy (at Least One Re-escalation) During a 24-month Observation Period After Study Enrollment (Split by SITT and MITT) |
7.7; 92.3 | — |
| SECONDARY Percentage of Participants With Change From Triple to Dual Therapy and Back to Triple Therapy (at Least One Re-escalation) During a 24-month Observation Period After Study Enrollment (Split by LAMA/LABA, ICS/LABA and ICS/LAMA) |
0.8; 0.3; 0.0; 98.9 | — |
| SECONDARY Percentage of Participants With at Least One Change From MITT to SITT or SITT to MITT During a 24-month Observation Period |
3.2; 3.9 | — |
| SECONDARY Percentage of Participants With at Least One Change From SITT to SITT or MITT to MITT During a 24-month Observation Period |
2.8; 1.3 | — |
| SECONDARY Percentage of Participants With Change From Once Daily to Twice Daily or Twice Daily to Once Daily Medication |
3.9; 3.2 | — |
| SECONDARY Percentage of Participants With a Change Between Different Inhaler Types |
7.8 | — |
| SECONDARY Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group |
2.6; 0.0; 2.6; 5.1; 2.6; 5.1 | — |
| SECONDARY Percentage of Participants With Reasons for Change in Their Triple Therapy to Another Triple Therapy in Overall Participants |
1.4; 0.0; 6.9; 5.6; 4.2; 2.8 | — |
| SECONDARY Percentage of Participants With Reasons for Change From Triple Therapy to Therapy De-escalation |
0.0; 0.0; 7.4; 3.7; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Reasons to Change De-escalated Therapy Back to Triple Therapy |
0.0; 0.0; 10.0; 0.0; 10.0; 0.0 | — |
| SECONDARY Mean Annual Rate of Moderate and/or Severe Exacerbations in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History |
0.156; 0.128; 0.102; 0.199; 0.445; 0.238 | — |
| SECONDARY Mean Annual Rate of Hospitalizations Due to Severe Exacerbations |
0.058 | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6 |
0.01; -0.04; 0.00; 0.02; -0.04; 0.02 | — |
| SECONDARY Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12 |
0.02; -0.07; -0.16; 0.03; -0.01; 0.04 | — |
| SECONDARY Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24 |
0.00; 0.04; -0.13; 0.00; -0.04; 0.03 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (FVC) in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 6 |
0.02; -0.03; -0.06; 0.02; 0.02; 0.01 | — |
| SECONDARY Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12 |
-0.02; -0.05; -0.24; -0.01; 0.22; -0.05 | — |
| SECONDARY Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24 |
-0.06; 0.02; -0.13; -0.06; 0.08; -0.06 | — |
| SECONDARY Percentage of Participants With Change in COPD Symptoms at Months 6, 12 and 24 From Baseline |
77.3; 15.6; 7.1; 81.3; 10.8; 7.9 | — |
| SECONDARY Change From Baseline in European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) at Months 12 and 24 |
-0.006; 0.003 | — |
| SECONDARY Percentage of Participants Experiencing a Clinically Important Deterioration |
53.6 | — |
| SECONDARY Time to First Moderate or Severe Exacerbation |
NA | — |
| SECONDARY Time to First Hospitalization |
NA | — |
| SECONDARY Time to Death |
NA | — |
| SECONDARY Number of COPD Related Visits |
5.8; 3.7 | — |
| SECONDARY Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Physician |
0.182; 0.140 | — |
| SECONDARY Mean Annual Rate of Hospitalization Due to Severe Exacerbation Over a 24-month Observation Period Categorized by Physician |
0.027; 0.078 | — |
| SECONDARY Percentage of Participants Categorized by the Site Localization of Physician and by Type of Physician |
9.2; 29.2; 29.5; 32.0; 33.0; 7.8 | — |
| SECONDARY Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Type of Physician and by Peripheral Blood Eosinophil Count, Smoking Status and Asthma History |
0.158; 0.143; 0.211; 0.187; 0.072; 0.119 | — |
| SECONDARY Number of Participants Who Had Pneumonia and Cardiovascular Events |
22; 23 | — |
| SECONDARY Number Needed to Treat for Benefit (NNTB) for SITT Participants Compared to Non SITT With Respect to Exacerbations, Pneumonia, and Cardiovascular Events |
58; 15; NA; NA; 1042; NA | — |
| SECONDARY Number Needed to Treat for Benefit (NNTB) for MITT Participants Compared to Non MITT With Respect to Exacerbations, Pneumonia, and Cardiovascular Events |
131; 25; 146; 91; 203; 98 | — |
| SECONDARY Number Needed to Treat for Benefit (NNTB) With Respect to Exacerbations, Pneumonia, and Cardiovascular Events for Participants Whose Triple Therapies Interrupted by ICS and/or LAMA "Off/on" Periods Compared to Other Triple Therapies |
NA; NA; 163; 41; 226; 61 | — |
| SECONDARY Number Needed to Treat for Benefit (NNTB) With Respect to Exacerbations, Pneumonia, and Cardiovascular Events for Participants With Switch of Triple Therapies Between SITT and MITT Compared to no Switch |
NA; NA; 159; 40; NA; NA | — |
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).
Data sourced from ClinicalTrials.gov (NCT04657211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.