Chronic Obstructive Pulmonary DiseaseMINERVANCT06422676
MultIceNtre Non-intERVentional Study for Efficacy,Safety Evaluation of BREZTRI in Pts With COPD in RussiA
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 14 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 200 participants
- Where
- 14 sitesRussia
- Study dates
- 29 Dec 2023to 18 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients >= 18 y.o. with moderate to severe COPD who are eligible for BREZTRI therapy
Who may be able to join
- 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).
Who cannot join
- Documented COPD due to α-1 antitrypsin deficiency;
- Previous treatment with triple fixed-dose combination in 12 months prior to inclusion;
- Pregnancy or lactation period;
- Concomitant uncontrolled disease;
- A diagnosis of bronchiectasis, sarcoidosis, interstitial lung disease, or idiopathic pulmonary fibrosis;
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Russia14 sites
Research Site
Blagoveshchensk
Research Site
Kazan'
Research Site
Krasnodar
Research Site
Krasnoyarsk
Research Site
Moscow
Research Site
Nizhny Novgorod
Research Site
Novosibirsk
Research Site
Omsk
Research Site
Rostov-on-Don
Research Site
Ryazan
Research Site
Saint Petersburg
Research Site
Ufa
Research Site
Volgograd
Research Site
Yekaterinburg
About this study
Official title: 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
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.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a disease characterized by persistent airflow limitation that is usually progresses and is a consequence of a chronic inflammatory response of the respiratory pathways and lung tissue to the effects of inhaled harmful particles or gases. Exacerbations and comorbid conditions are an integral part of the disease and contribute significantly to the clinical picture and prognosis [1].
Patient-reported outcomes (both symptom-based and health-related quality of life-specific) are essential to evaluate symptoms, impact of symptoms on activities of daily living, and treatment response in COPD patients [12].
There is a need to evaluate the patient-reported outcomes during a triple therapy with budesonide + glycopyrronium bromide + formoterol (Breztri) in a real-life clinical practice. The aim of the study is to evaluate clinical and patient-reported outcomes of treatment with BREZTRI through effectiveness measures assessed pre- and post-treatment initiation and safety monitoring. The study results will be interpreted in the context of an open label, single arm study design where multiple factors, in addition to the new treatment, may contribute to the treatment effect.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, COPD, BREZTRI
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (9)
Change in COPD Assessment Test (CAT) score
Change from baseline to 12 weeks in the CAT score. Minimum value - "0", maximum value - "5". Higher scores mean worse outcome.
Measured: 12 weeks
Change in FEV1
Change from baseline to 24 weeks in FEV1
Measured: 24 weeks
Change in the Treatment Satisfaction Questionnaire for Medication (TSQM) score
Change from baseline to 24 weeks in the TSQM score. Minimum score - "1", maximum score - "7". Higher scores mean better outcome.
Measured: 24 weeks
MCID >= 2
- Percent of responders using the CAT who achieved MCID (minimal clinically important difference) = 2 or more points after 24 weeks of treatment
Measured: 24 weeks of treatment
>= 20 points at MARS
Percent of patients who are high adherent to therapy (who received 20 or more points at MARS) during 24 weeks;
Measured: 24 weeks
PGI-C - any improvement
Percent of patients with response (any category better than "no change") at the PGI-C after 24 weeks of treatment
Measured: 24 weeks of treatment
PGI-S - change from baseline
- Percent of patients with change from baseline (before Breztri treatment start) in the severity of general COPD symptoms at the PGI-S after 24 weeks of treatment
Measured: after 24 weeks of treatment
To describe treatment safety by AE (adverse events) monitoring
to monitor AE frequency
Measured: AEs will be collected from the day when the informed consent has been signed (Visit 0) until the time last visit (Visit 2- 24 (+2) weeks after index date) has occurred
Treatment safety by AE monitoring
to collect information on treatment discontinuation due to AE
Measured: AEs will be collected from the day when the informed consent has been signed (Visit 0) until the time last visit (Visit 2- 24 (+2) weeks after index date) has occurred
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start29 Dec 2023
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422676
- Sponsor's protocol ID
- D5980R00097
- Acronym
- MINERVA
- Status last verified
- Apr 2026
- First submitted
- 29 Feb 2024
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06422676
- Acronym / sponsor ID
- MINERVA / D5980R00097
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, COPD, BREZTRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2023 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a disease characterized by persistent airflow limitation that is usually progresses and is a consequence of a chronic inflammatory response of the respiratory pathways and lung tissue to the effects of inhaled harmful particles or gases. Exacerbations and comorbid conditions are an integral part of the disease and contribute significantly to the clinical picture and prognosis [1].
Patient-reported outcomes (both symptom-based and health-related quality of life-specific) are essential to evaluate symptoms, impact of symptoms on activities of daily living, and treatment response in COPD patients [12].
There is a need to evaluate the patient-reported outcomes during a triple therapy with budesonide + glycopyrronium bromide + formoterol (Breztri) in a real-life clinical practice. The aim of the study is to evaluate clinical and patient-reported outcomes of treatment with BREZTRI through effectiveness measures assessed pre- and post-treatment initiation and safety monitoring. The study results will be interpreted in the context of an open label, single arm study design where multiple factors, in addition to the new treatment, may contribute to the treatment effect.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients >= 18 y.o. with moderate to severe COPD who are eligible for BREZTRI therapy
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Documented COPD due to α-1 antitrypsin deficiency;
- Previous treatment with triple fixed-dose combination in 12 months prior to inclusion;
- Pregnancy or lactation period;
- Concomitant uncontrolled disease;
- A diagnosis of bronchiectasis, sarcoidosis, interstitial lung disease, or idiopathic pulmonary fibrosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in COPD Assessment Test (CAT) score
Time frame: 24 weeks
Change from baseline to 24 weeks in the CAT score. Minimum value - "0", maximum value - "5". Higher scores mean worse outcome.
9 secondary outcomes
Change in COPD Assessment Test (CAT) score
Time frame: 12 weeks
Change in FEV1
Time frame: 24 weeks
Change in the Treatment Satisfaction Questionnaire for Medication (TSQM) score
Time frame: 24 weeks
MCID >= 2
Time frame: 24 weeks of treatment
>= 20 points at MARS
Time frame: 24 weeks
PGI-C - any improvement
Time frame: 24 weeks of treatment
PGI-S - change from baseline
Time frame: after 24 weeks of treatment
To describe treatment safety by AE (adverse events) monitoring
Time frame: AEs will be collected from the day when the informed consent has been signed (Visit 0) until the time last visit (Visit 2- 24 (+2) weeks after index date) has occurred
Treatment safety by AE monitoring
Time frame: AEs will be collected from the day when the informed consent has been signed (Visit 0) until the time last visit (Visit 2- 24 (+2) weeks after index date) has occurred
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 14 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in COPD Assessment Test (CAT) score (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.