Recruiting

iCHOROSBreztri/Trixeo Outcomes in Moderate to Severe COPD

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Chronic Disease+5

+ Lung Diseases

+ Lung Diseases, Obstructive

From 30 to 80 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: December 2025
See protocol details

Summary

Principal SponsorAstraZeneca
Study ContactAstraZeneca Clinical Study Information Center
Last updated: March 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 15, 2025

Actual date on which the first participant was enrolled.

This study focuses on adults with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) who are being treated with a medication called Breztri/Trixeo. COPD is a serious lung condition that makes it hard to breathe and often gets worse over time, leading to frequent hospital visits and a significant impact on quality of life, especially in countries with fewer healthcare resources. The study aims to gather real-world data on how well Breztri/Trixeo works outside of controlled clinical trials. This will involve understanding its effectiveness, safety, and the patient experience, which is crucial for improving treatment strategies and outcomes for those living with COPD across different parts of the world, including Latin America, Asia, and the Middle East. Participants in the study will use Breztri/Trixeo, which is an inhaler that delivers three medications to help manage COPD symptoms. The study will track changes in participants' health by measuring their scores on the COPD Assessment Test (CAT) after 12 weeks of treatment, with additional checks at 26 and 52 weeks. Other important measures will include the frequency of COPD flare-ups and patient satisfaction with the inhaler. The study will involve routine visits to the doctor, where information such as medical history and medication use will be collected. Doctors will decide on all treatments, ensuring that the study reflects typical real-world medical practice. The study will last for up to 52 weeks for each participant, providing valuable insights into how Breztri/Trixeo performs in everyday use.

Official TitleReal-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
NCT07069829
Principal SponsorAstraZeneca
Study ContactAstraZeneca Clinical Study Information Center
Last updated: March 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1400 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsDisease AttributesPulmonary Disease, Chronic Obstructive

Criteria

4 inclusion criteria required to participate
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.

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.

Patients able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol.

8 exclusion criteria prevent from participating
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.

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.

Patients with recent (≤3 months) major cardiac or pulmonary events that required hospitalization (e.g., myocardial infarction, pulmonary embolism).

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 12 locations

Recruiting

Research Site

Alexandria, EgyptOpen Research Site in Google Maps
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Research Site

Cairo, Egypt
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Research Site

Abhā, Saudi Arabia
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Research Site

Riyadh, Saudi Arabia
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12 Study Centers