## Protocol Section
### Identification Module
**NCT ID:** NCT06422676

**Acronym:** MINERVA

**Brief Title:** MultIceNtre Non-intERVentional Study for Efficacy,Safety Evaluation of BREZTRI in Pts With COPD in RussiA

**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

#### Organization Study ID Info
**ID:** D5980R00097
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-12-29

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-29
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AstraZeneca

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

**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 Module

**Conditions:**

- Chronic Obstructive Pulmonary Disease

**Keywords:**

- Chronic obstructive pulmonary disease

- COPD

- BREZTRI

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Change from baseline to 24 weeks in the CAT score. Minimum value - "0", maximum value - "5". Higher scores mean worse outcome.

**Measure:** Change in COPD Assessment Test (CAT) score

**Time Frame:** 24 weeks

#### Secondary Outcomes

**Description:** Change from baseline to 12 weeks in the CAT score. Minimum value - "0", maximum value - "5". Higher scores mean worse outcome.

**Measure:** Change in COPD Assessment Test (CAT) score

**Time Frame:** 12 weeks

**Description:** Change from baseline to 24 weeks in FEV1

**Measure:** Change in FEV1

**Time Frame:** 24 weeks

**Description:** Change from baseline to 24 weeks in the TSQM score. Minimum score - "1", maximum score - "7". Higher scores mean better outcome.

**Measure:** Change in the Treatment Satisfaction Questionnaire for Medication (TSQM) score

**Time Frame:** 24 weeks

**Description:** • Percent of responders using the CAT who achieved MCID (minimal clinically important difference) = 2 or more points after 24 weeks of treatment

**Measure:** MCID >= 2

**Time Frame:** 24 weeks of treatment

**Description:** Percent of patients who are high adherent to therapy (who received 20 or more points at MARS) during 24 weeks;

**Measure:** >= 20 points at MARS

**Time Frame:** 24 weeks

**Description:** Percent of patients with response (any category better than "no change") at the PGI-C after 24 weeks of treatment

**Measure:** PGI-C - any improvement

**Time Frame:** 24 weeks of treatment

**Description:** • 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

**Measure:** PGI-S - change from baseline

**Time Frame:** after 24 weeks of treatment

**Description:** to monitor AE frequency

**Measure:** 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

**Description:** to collect information on treatment discontinuation due to AE

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Physician-diagnosed COPD no less than 12 months before BREZTRI treatment start;
2. Patients who have not achieved adequate disease control when treated with a combination of ICS and LABA or a combination of LABA and LAMA
3. Initiated treatment with BREZTRI ≤12 weeks before inclusion as prescribed according to the label;
4. CAT score not more than 1 week before BREZTRI start is available;
5. Patients must be able and willing to read, comprehend and follow written instructions, and to comprehend and complete the questionnaires required by the protocol
6. Have signed a written Informed Consent Form (ICF).

Exclusion Criteria:

1. Documented COPD due to α-1 antitrypsin deficiency;
2. Previous treatment with triple fixed-dose combination in 12 months prior to inclusion;
3. Pregnancy or lactation period;
4. Concomitant uncontrolled disease;
5. A diagnosis of bronchiectasis, sarcoidosis, interstitial lung disease, or idiopathic pulmonary fibrosis;
6. 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.

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Patients \>= 18 y.o. with moderate to severe COPD who are eligible for BREZTRI therapy

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** information.center@astrazeneca.com

**Name:** AstraZeneca Clinical Study Information Center

**Phone:** 1-877-240-9479

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Saint-Petersburg

**Contacts:**

***Contact 1:***

- **Email:** veronika965@list.ru

- **Role:** CONTACT

***Contact 2:***

- **Name:** Veronika Popova

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Russian Federation

**Facility:** Reavita Medical Centre

**Status:** RECRUITING

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11168

- Name: Lung Diseases

- Relevance: HIGH

- As Found: Pulmonary Disease

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: HIGH

- As Found: Obstructive Pulmonary Disease

- ID: M23449

- Name: Pulmonary Disease, Chronic Obstructive

- Relevance: HIGH

- As Found: Chronic Obstructive Pulmonary Disease

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008171

- Term: Lung Diseases

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000029424

- Term: Pulmonary Disease, Chronic Obstructive

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21711

- Name: Budesonide

- Relevance: LOW

- As Found: Unknown

- ID: M304

- Name: Formoterol Fumarate

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
