CompletedNot Applicable

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

Russia200 participantsStarted 2023-12-29

Plain-language 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.

Who can participate

SexALL

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Inclusion criteria

✓. 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).

Exclusion criteria

✕. 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.

What they're measuring

Change in COPD Assessment Test (CAT) score

Timeframe: 24 weeks

Trial details

NCT IDNCT06422676

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12-18

View on ClinicalTrials.gov More Chronic Obstructive Pulmonary Disease trials