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

AstraZeneca200 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (14)

Research Site

Blagoveshchensk, Russia

Research Site

Kazan', Russia

Research Site

Krasnodar, Russia

Research Site

Outcomes

Primary Outcomes

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.

Time frame: 24 weeks

Secondary Outcomes

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.

Time frame: 12 weeks

Change in FEV1

Change from baseline to 24 weeks in FEV1

Time frame: 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.

Time frame: 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

Time frame: 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;

Time frame: 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

Time frame: 24 weeks of treatment

PGI-S - change from baseline

Data from ClinicalTrials.gov

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