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

Recruiting · NCT07069829 · Observational (researchers observe without assigning treatment) · Lead sponsor: AstraZeneca

View the official record on ClinicalTrials.gov →

What this trial is about

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

Who can take part

Age range

30 Years to 80 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not specified

Study type

Observational (researchers observe without assigning treatment)

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:
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.
\*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.

Exclusion criteria

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.

Where it is running

36 locations listed.

Research Site - Abhā, Saudi Arabia
Research Site - Alexandria, Egypt
Research Site - Amman, Jordan
Research Site - Bangkok, Thailand
Research Site - Barranquilla, Colombia
Research Site - Buenos Aires, Argentina
Research Site - Cairo, Egypt
Research Site - Cairo, Egypt
Research Site - Dubai, United Arab Emirates
Research Site - Dubai, United Arab Emirates
Research Site - Guadalajara, Mexico
Research Site - Ho Chi Minh City, Vietnam
Research Site - Jakarta, Indonesia
Research Site - Jakarta, Indonesia
Research Site - Kuala Lumpur, Malaysia
Research Site - Kuching, Malaysia
Research Site - La Plata, Argentina
Research Site - Malacca, Malaysia
Research Site - Mar del Plata, Argentina
Research Site - Mendoza, Argentina
Research Site - Mexico City, Mexico
Research Site - Monterrey, Mexico
Research Site - Nonthaburi, Thailand
Research Site - Rionegro, Colombia
Research Site - Riyadh, Saudi Arabia
Research Site - Riyadh, Saudi Arabia
Research Site - Taichung, Taiwan
Research Site - Tainan, Taiwan
Research Site - Taipei, Taiwan
Research Site - Bogotá, Colombia, Colombia
Research Site - Medell N, Colombia, Colombia
Research Site - Jawa Barat, Indonesia, Indonesia
Research Site - George Town, Malaysia, Malaysia
Research Site - Kuala Selangor, Malaysia, Malaysia
Research Site - Yunlin, Taiwan, Taiwan
Research Site - Hà Nội, Vietnam, Vietnam

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →