Triple Therapy in Chronic Obstructive Pulmonary Disease (COPD) Participants

NCT04657211 | Completed Results

• 1 other identifier: 214468
• Study Type: observational
• Target: 1,212
• Locations: 1 country
• Sites: 1

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).

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD; LABA; LAMA; ICS; TETRIS

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants Who Continuously Received Triple Therapy for 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.

  From Day 1 (Month 1) up to 6 months

• Percentage of Participants Who Continuously Received Triple Therapy for 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.

  From Day 1 (Month 1) up to 12 months

• Percentage of Participants Who Continuously Received Triple Therapy for 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.

  From Day 1 (Month 1) up to 24 months

• Time to Stop Triple Therapy

  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.

  Up to 24 months

Secondary Outcomes (52)

• Percentage of Participants With Diagnosis of Asthma at the Age of <40 Years

  Baseline (Day 1)

• 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 With a Physician's Diagnosis of COPD by Physicians Group

  Baseline (Day 1)

• Percentage of Participants With COPD Symptom and Risk Classes (GOLD 1 to 4) at Baseline

  Baseline (Day 1)

Study Arms (1)

Participants with chronic obstructive pulmonary disease (COPD)

Participants with COPD, who will be treated with triple therapy (single inhaler triple therapy \[SITT\] or multiple inhaler triple therapy \[MITT\]) for at least 2 but not longer than 48 weeks will be enrolled in this study. No study treatment will be administered during conduct of this study.

Other: Prospective observational cohort study

Interventions

Prospective observational cohort study OTHER

prospective observational cohort study

Participants with chronic obstructive pulmonary disease (COPD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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").
• Participants need to give and be capable of giving signed informed consent form (ICF).

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Hanover, 30625, Germany

Location

Related Publications (2)

• Rohde G, Vogelmeier CF, Beeh KM, Kardos P, Paulsson T, Watz H, Westermayer B, Mohan T, Noorduyn SG, Claussen J. TETRIS - Prospective study to observe clinical outcomes of triple therapy in COPD patients: Up to 12 months interim analysis. Respir Med. 2026 Jan;251:108597. doi: 10.1016/j.rmed.2025.108597. Epub 2025 Dec 17.

  PMID: 41418889 DERIVED

• Vogelmeier CF, Beeh KM, Kardos P, Paulsson T, Rohde G, Watz H, Compton C, Mohan T, Claussen J. Baseline patient demographics for TETRIS: a prospective, noninterventional study to characterize the use of triple therapy for COPD in Germany. Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241287621. doi: 10.1177/17534666241287621.

  PMID: 39436955 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: January 14, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 17, 2025
• Results First Posted: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)