Triple thErapy in paTients With COPD Under Real lIve Setting (the TETRIS Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- GlaxoSmithKline
- Enrollment
- 1212
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Who Continuously Received Triple Therapy for 6 Months
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
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).
Outcomes
Primary Outcomes
Percentage of Participants Who Continuously Received Triple Therapy for 6 Months
Time Frame: From Day 1 (Month 1) up to 6 months
Percentage of participants who continuously received triple therapy (SITT or MITT) for 6 months from visit 1 (Day 1 of Month 1) have been presented. Percentage values are rounded-off.
Percentage of Participants Who Continuously Received Triple Therapy for 12 Months
Time Frame: From Day 1 (Month 1) up to 12 months
Percentage of participants who continuously received triple therapy (SITT or MITT) for 12 months from visit 1 (Day 1 of Month 1) have been presented. Percentage values are rounded-off.
Time to Stop Triple Therapy
Time Frame: Up to 24 months
Time to stop triple therapy refers to the time duration from visit 1 at which a triple therapy (SITT or MITT) was safely and appropriately discontinued because its intended goals had been achieved, or no longer attainable, or risks outweighed the benefits. It was evaluated by Kaplan-Maier analysis.
Percentage of Participants Who Continuously Received Triple Therapy for 24 Months
Time Frame: From Day 1 (Month 1) up to 24 months
Percentage of participants who continuously received triple therapy (SITT or MITT) for 24 months from visit 1 (Day 1 of Month 1) have been presented. Percentage values are rounded-off.
Secondary Outcomes
- 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(Baseline (Day 1))
- Percentage of Participants With a Physician's Diagnosis of COPD by Site Localization(Baseline (Day 1))
- Percentage of Participants by Their Duration of Triple Therapy Before Study Start(Up to 48 weeks before study start (Day 1 of Month 1))
- 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(Baseline (Day 1), Months 6, 12, and 24)
- 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)(Up to 24 months)
- Percentage of Participants With at Least One Change From SITT to SITT or MITT to MITT During a 24-month Observation Period(Up to 24 months)
- Percentage of Participants With a Physician's Diagnosis of COPD by Physicians Group(Baseline (Day 1))
- Percentage of Participants by Their Smoking Status at Months 6, 12 and 24(At Months 6, 12 and 24)
- 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(Up to 24 months prior to Baseline (Day 1); Up to 3 months prior to Month 6; Up to 3 months prior to Month 12; Up to 3 months prior to Month 24)
- Percentage of Participants With Peripheral Blood EOS Count of <300 and >=300 Cells/uL at 6, 12 and 24 Months(At Months 6, 12, and 24)
- Percentage of Participants With Chronic Bronchitis Phenotype(Up to 24 months)
- Percentage of Participants With at Least One Switch From Triple Therapy to Inhaled Corticosteroids (ICS)/LABA From Months 6 to 24(Months 6 to 24)
- 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)(Up to 24 months)
- Percentage of Participants With at Least One Change From MITT to SITT or SITT to MITT During a 24-month Observation Period(Up to 24 months)
- Percentage of Participants With Diagnosis of Asthma at the Age of <40 Years(Baseline (Day 1))
- Percentage of Participants With COPD Symptom and Risk Classes (GOLD 1 to 4) at Baseline(Baseline (Day 1))
- Percentage of Participants With COPD Symptom and Risk Classes (GOLD A to D) at Baseline(Baseline (Day 1))
- Percentage of Participants Who Received Concomitant Respiratory Medication at Months 6, 12 and 24(At Months 6, 12 and 24)
- Percentage of Participants With a Lifelong Non-smoking History at Baseline(At Baseline (Day 1))
- Percentage of Participants With a COPD Assessment Test (CAT) Score <=10, 11-19, >=20 at Baseline and at 6, 12 and 24 Months Documentation(Baseline (Day 1), Months 6, 12, and 24)
- 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(Months 6 to 24)
- Percentage of Participants With Reasons to Start COPD Triple Therapy in Overall and by Physician Group(Up to 24 months)
- Percentage of Participants With Change From Once Daily to Twice Daily or Twice Daily to Once Daily Medication(Up to 24 months)
- Percentage of Participants With a Change Between Different Inhaler Types(Up to 24 months)
- Percentage of Participants With Prespecified Reasons to Change a Triple Therapy (Either MITT or SITT) by Type of Physician Group(Up to 24 months)
- Percentage of Participants With Reasons for Change in Their Triple Therapy to Another Triple Therapy in Overall Participants(Up to 24 months)
- Percentage of Participants With Reasons for Change From Triple Therapy to Therapy De-escalation(Up to 24 months)
- Percentage of Participants With Reasons to Change De-escalated Therapy Back to Triple Therapy(Up to 24 months)
- Mean Annual Rate of Moderate and/or Severe Exacerbations in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History(Up to 24 months)
- Mean Annual Rate of Hospitalizations Due to Severe Exacerbations(Up to 24 months)
- 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(Baseline (Day 1) and at Month 6)
- Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12(Baseline (Day 1) and at Month 12)
- Change From Baseline in FEV1 in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24(Baseline (Day 1) and at Month 24)
- 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(Baseline (Day 1) and at Month 6)
- Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 12(Baseline (Day 1) and at Month 12)
- Change From Baseline in FVC in Overall Participants and by Their Peripheral Blood Eosinophil Count, Smoking Status and Asthma History at Month 24(Baseline (Day 1) and at Month 24)
- Percentage of Participants With Change in COPD Symptoms at Months 6, 12 and 24 From Baseline(Baseline (Day 1), Months 6, 12 and 24)
- Change From Baseline in European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) at Months 12 and 24(Baseline (Day 1), Months 12 and 24)
- Percentage of Participants Experiencing a Clinically Important Deterioration(Up to 24 months)
- Time to First Moderate or Severe Exacerbation(Up to 24 months)
- Time to First Hospitalization(Up to 24 months)
- Time to Death(Up to 24 months)
- Number of COPD Related Visits(Up to 24 months)
- Mean Annual Rate of Exacerbations Over a 24-month Observation Period Categorized by Physician(Up to 24 months)
- Mean Annual Rate of Hospitalization Due to Severe Exacerbation Over a 24-month Observation Period Categorized by Physician(Up to 24 months)
- Percentage of Participants Categorized by the Site Localization of Physician and by Type of Physician(Up to 24 months)
- 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(Up to 24 months)
- Number of Participants Who Had Pneumonia and Cardiovascular Events(Up to 24 months)
- Number Needed to Treat for Benefit (NNTB) for SITT Participants Compared to Non SITT With Respect to Exacerbations, Pneumonia, and Cardiovascular Events(Days 90 and 365)
- Number Needed to Treat for Benefit (NNTB) for MITT Participants Compared to Non MITT With Respect to Exacerbations, Pneumonia, and Cardiovascular Events(Days 90 and 365)
- 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(Days 90 and 365)
- 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(Days 90 and 365)