MultIceNtre Non-intERVentional Study for Efficacy,Safety Evaluation of BREZTRI in Pts With COPD in RussiA
MINERVA
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
1 other identifier
observational
200
1 country
14
Brief Summary
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.
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 2023
Shorter than P25 for all trials
14 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
Study Start
First participant enrolled
December 29, 2023
CompletedFirst Submitted
Initial submission to the registry
February 29, 2024
CompletedFirst Posted
Study publicly available on registry
May 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2024
CompletedMay 1, 2026
April 1, 2026
12 months
February 29, 2024
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in COPD Assessment Test (CAT) score
Change from baseline to 24 weeks in the CAT score. Minimum value - "0", maximum value - "5". Higher scores mean worse outcome.
24 weeks
Secondary Outcomes (9)
Change in COPD Assessment Test (CAT) score
12 weeks
Change in FEV1
24 weeks
Change in the Treatment Satisfaction Questionnaire for Medication (TSQM) score
24 weeks
MCID >= 2
24 weeks of treatment
>= 20 points at MARS
24 weeks
- +4 more secondary outcomes
Eligibility Criteria
Patients \>= 18 y.o. with moderate to severe COPD who are eligible for BREZTRI therapy
You may qualify if:
- 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
- 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).
You may not qualify if:
- Documented COPD due to α-1 antitrypsin deficiency;
- Pregnancy or lactation period;
- Concomitant uncontrolled disease;
- A diagnosis of bronchiectasis, sarcoidosis, interstitial lung disease, or idiopathic pulmonary fibrosis;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (14)
Research Site
Blagoveshchensk, Russia
Research Site
Kazan', Russia
Research Site
Krasnodar, Russia
Research Site
Krasnoyarsk, Russia
Research Site
Moscow, Russia
Research Site
Nizhny Novgorod, Russia
Research Site
Novosibirsk, Russia
Research Site
Omsk, Russia
Research Site
Rostov-on-Don, Russia
Research Site
Ryazan, Russia
Research Site
Saint Petersburg, Russia
Research Site
Ufa, Russia
Research Site
Volgograd, Russia
Research Site
Yekaterinburg, Russia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 29, 2024
First Posted
May 21, 2024
Study Start
December 29, 2023
Primary Completion
December 18, 2024
Study Completion
December 18, 2024
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA 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 anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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.