NCT06422676Completed
MultIceNtre Non-intERVentional Study for Efficacy,Safety Evaluation of BREZTRI in Pts With COPD in RussiA
Open-label Single-arm, Non-interventional, Multi-centre, Cohort Study for Evaluation of Clinical and Patient Reported Outcomes in New Users of BREZTRI (Budesonide / Glycopyrronium / Formoterol) in Routine Care Settings
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
This is a retrospective-prospective, non-interventional, multi-centre study that will be conducted in routine clinical settings in Russia. Eligible patients with moderate to severe COPD routinely treated with BREZTRI will be observed according to routine clinical practice for up to 24 weeks.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 200 (actual)
- First submitted
- 29 Feb 2024
- Start date
- 29 Dec 2023
- Primary completion date
- 18 Dec 2024
- Lead sponsor
- AstraZeneca
- Diseases
- COPD
- NCT number
- NCT06422676
What you commit to
- Study type: Observational
- Participants enrolled: 200
- From 29 Dec 2023 to the primary completion date, 18 Dec 2024
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with triple fixed-dose combination in 12 months prior to inclusion;
- Concomitant uncontrolled disease;
- Participation in other non-interventional observational trials that might, in the investigator's opinion, influence the assessment for the current study, or participation in any observational or clinical trial in the last 30 days prior to inclusion.
Other illness
- A diagnosis of bronchiectasis, sarcoidosis, interstitial lung disease, or idiopathic pulmonary fibrosis;
Other
- Documented COPD due to α-1 antitrypsin deficiency;
- Pregnancy or lactation period;
Who the study is looking for
- Physician-diagnosed COPD no less than 12 months before BREZTRI treatment start;
- Patients who have not achieved adequate disease control when treated with a combination of ICS and LABA or a combination of LABA and LAMA
- Initiated treatment with BREZTRI ≤12 weeks before inclusion as prescribed according to the label;
- CAT score not more than 1 week before BREZTRI start is available;
- Patients must be able and willing to read, comprehend and follow written instructions, and to comprehend and complete the questionnaires required by the protocol
- Have signed a written Informed Consent Form (ICF).
Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.