Ireland
--:--IST
Recruiting Observational

Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/Trixeo

NCT07069829 · tracked via the Priya Life Science Taiwan tracker
Phase
Observational
Started
2025-12-15
Last updated
2026-09-14

Condition(s) studied

Chronic Obstructive Pulmonary Disease

Study summary

Chronic Obstructive Pulmonary Disease is a leading cause of global morbidity and mortality, especially in low- and middle-income countries. Exacerbations accelerate disease progression and increase the risk of death. Recent recommendations from the GOLD report emphasize the diagnosis of COPD and treatment planning based on a combination of lung function metrics, exacerbation history, and patient-reported symptoms. It is recommending the use of triple combination therapy (ICS+LABA+LAMA) such as BREZTRI/TRIXEO as one of the options in Group E patients. While BGF has demonstrated efficacy in controlled clinical trials, real-world evidence is needed to assess its impact on daily patient outcomes and quality of life.

The iCHOROS study is a real-world, international, multicenter, observational study aiming to evaluate changes in clinical and patient-reported outcomes in adults with moderate to severe COPD treated with BGF for 12 months in routine care settings across Latin America, Asia, and the Middle East \& Africa. The study will provide valuable insights into the effectiveness and patient experience of BGF therapy in diverse, real-world populations

Eligibility

Sex
ALL
Min age
30 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: The study will include patients who were prescribed BGF, but not yet initiated, according to the label (SmPC) and local market reimbursement criteria. Patients will only be included in the study if they meet the following inclusion criteria: 1. Patients diagnosed with COPD, at least 12 months before baseline, as assessed per physician's routine practice or as documented in the patient's chart. 2. Male or female patients aged over 30 years and under 80 years at the time of enrolment. 3. Patients providing a written Informed Consent\* prior to inclusion to the study. \*Prescription of BGF should be prior to the signed informed consent and the decision to prescribe this therapy is clearly separated from the physician's decision to include the patient in the current study. 4. Patients able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol. Exclusion Criteria: Patients who meet any of the following criteria will not be eligible to participate in the study: 1. Patients with COPD due to documented α-1 antitrypsin deficiency. 2. Patients with recent (≤3 months) major cardiac or pulmonary events that required hospitalization (e.g., myocardial infarction, pulmonary embolism). 3. Patients previously treated with triple fixed-dose combination therapies 12 months before the screening visit or treated with Multiple Inhaled Triple Therapy (MITT) within the last 3 months before the screening visit. 4. Patients hospitalized due to COPD exacerbations within the last 30 days prior to enrolment. 5. Currently pregnant (or intending to become pregnant), breastfeeding, or lactating women. 6. Patients with a current diagnosis of asthma, active tuberculosis, lung cancer or lung metastasis, significant bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases, or other active clinically significant pulmonary diseases. 7. Patients currently participating in a non-interventional observational trial that might, in the investigator's opinion, influence the assessment for the current study or participation in any interventional trial in the last 30 days prior to enrolment. 8. Patients with respiratory tract infection (including COVID-19 infection) ) that has not resolved ≤30 days prior to BGF MDI initiation and those exhibiting persistent long-COVID symptoms are excluded from the study.

Primary outcome measure(s)

  • change from baseline in the COPD Assessment Test — 12 weeks
    Mean change from baseline in the COPD Assessment Test (CAT) scores after 12 weeks from treatment initiation

Trial sites (36)

FacilityCityRegionStatus
Research Site Buenos Aires Argentina Not Yet Recruiting
Research Site La Plata Argentina Not Yet Recruiting
Research Site Mar del Plata Argentina Not Yet Recruiting
Research Site Mendoza Argentina Not Yet Recruiting
Research Site Bogotá Colombia Not Yet Recruiting
Research Site Medell N Colombia Not Yet Recruiting
Research Site Barranquilla Colombia Not Yet Recruiting
Research Site Rionegro Colombia Recruiting
Research Site Alexandria Egypt Recruiting
Research Site Cairo Egypt Recruiting
Research Site Cairo Egypt Not Yet Recruiting
Research Site Jawa Barat Indonesia Recruiting
Research Site Jakarta Indonesia Not Yet Recruiting
Research Site Jakarta Indonesia Recruiting
Research Site Amman Jordan Recruiting
Research Site George Town Malaysia Not Yet Recruiting
Research Site Kuala Selangor Malaysia Recruiting
Research Site Kuala Lumpur Malaysia Recruiting
Research Site Kuching Malaysia Not Yet Recruiting
Research Site Malacca Malaysia Not Yet Recruiting
Research Site Guadalajara Mexico Not Yet Recruiting
Research Site Mexico City Mexico Not Yet Recruiting
Research Site Monterrey Mexico Not Yet Recruiting
Research Site Abhā Saudi Arabia Recruiting
Research Site Riyadh Saudi Arabia Recruiting
Research Site Riyadh Saudi Arabia Not Yet Recruiting
Research Site Yunlin Taiwan Recruiting
Research Site Taichung Taiwan Recruiting
Research Site Tainan Taiwan Recruiting
Research Site Taipei Taiwan Recruiting
Research Site Bangkok Thailand Recruiting
Research Site Nonthaburi Thailand Recruiting
Research Site Dubai United Arab Emirates Recruiting
Research Site Dubai United Arab Emirates Not Yet Recruiting
Research Site Hà Nội Vietnam Recruiting
Research Site Ho Chi Minh City Vietnam Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07069829 on ClinicalTrials.gov ↗ ← All trials in Taiwan