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

Chronic Obstructive Pulmonary Disease Clinical Trial

— MINERVA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06422676
• Other study ID #: D5980R00097
• Status: Recruiting
• Start date: December 29, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 a-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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Russian Federation	Reavita Medical Centre	Saint-Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 weeks
Secondary	Change in FEV1	Change from baseline to 24 weeks in FEV1	24 weeks
Secondary	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.	24 weeks
Secondary	MCID >= 2	• Percent of responders using the CAT who achieved MCID (minimal clinically important difference) = 2 or more points after 24 weeks of treatment	24 weeks of treatment
Secondary	>= 20 points at MARS	Percent of patients who are high adherent to therapy (who received 20 or more points at MARS) during 24 weeks;	24 weeks
Secondary	PGI-C - any improvement	Percent of patients with response (any category better than "no change") at the PGI-C after 24 weeks of treatment	24 weeks of treatment
Secondary	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	after 24 weeks of treatment
Secondary	To describe treatment safety by AE (adverse events) monitoring	to monitor AE frequency	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
Secondary	Treatment safety by AE monitoring	to collect information on treatment discontinuation due to AE	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