Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/Trixeo
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-80
SponsorAstraZeneca
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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 providing a written Informed Consent* prior to inclusion to the study.
Patients able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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
Time frame
12 weeksSecondary outcomes
1
CAT scores
Mean change from baseline in CAT scores after 26 weeks of treatment
Time frame
26 Weeks2
CAT scores
Mean change from baseline in CAT scores after 52 weeks of treatment
Time frame
52 weeks3
CAT scores
Percent of responders of the CAT achieving MCID ≥ 2 after 12 weeks of treatment compared to baseline.
Time frame
12 weeks4
TSQM - 9 Score
IQVIA Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9)© scores at baseline
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov