Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/Trixeo
iCHOROS
Real-world, International, Multicentre, Non-interventional, Prospective Cohort to Assess Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/Trixeo in Routine Care Settings
1 other identifier
observational
1,400
9 countries
21
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2025
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2025
CompletedFirst Posted
Study publicly available on registry
July 17, 2025
CompletedStudy Start
First participant enrolled
December 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
May 26, 2026
May 1, 2026
1.8 years
July 8, 2025
May 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change from baseline in the COPD Assessment Test
Mean change from baseline in the COPD Assessment Test (CAT) scores after 12 weeks from treatment initiation
12 weeks
Secondary Outcomes (14)
CAT scores
26 Weeks
CAT scores
52 weeks
CAT scores
12 weeks
TSQM - 9 Score
Baseline
TSQM - 9 Score
12 weeks
- +9 more secondary outcomes
Eligibility Criteria
The study plans to enroll approximately 1,400 patients, accounting for an expected dropout rate or missing data of \~20%, to ensure that at least 1,120 patients complete the study.
You may qualify if:
- 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.
- Male or female patients aged over 30 years and under 80 years at the time of enrolment.
- \*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.
- Patients able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol.
You may not qualify if:
- Patients who meet any of the following criteria will not be eligible to participate in the study:
- Patients with COPD due to documented α-1 antitrypsin deficiency.
- Patients with recent (≤3 months) major cardiac or pulmonary events that required hospitalization (e.g., myocardial infarction, pulmonary embolism).
- 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.
- Patients hospitalized due to COPD exacerbations within the last 30 days prior to enrolment.
- Currently pregnant (or intending to become pregnant), breastfeeding, or lactating women.
- 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.
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (21)
Research Site
Alexandria, Egypt
Research Site
Cairo, Egypt
Research Site
Cairo, Egypt
Research Site
Jawa Barat, Indonesia, Indonesia
Research Site
Jakarta, Indonesia
Research Site
Jakarta, Indonesia
Research Site
Amman, Jordan
Research Site
Kuala Selangor, Malaysia, Malaysia
Research Site
Abhā, Saudi Arabia
Research Site
Riyadh, Saudi Arabia
Research Site
Riyadh, Saudi Arabia
Research Site
Yunlin, Taiwan, Taiwan
Research Site
Taichung, Taiwan
Research Site
Tainan, Taiwan
Research Site
Taipei, Taiwan
Research Site
Bangkok, Thailand
Research Site
Nonthaburi, Thailand
Research Site
Dubai, United Arab Emirates
Research Site
Dubai, United Arab Emirates
Research Site
Hà Nội, Vietnam, Vietnam
Research Site
Ho Chi Minh City, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2025
First Posted
July 17, 2025
Study Start
December 15, 2025
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
May 26, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.