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

CompletedN/A

Sponsor: AstraZeneca

Conditions: Chronic Obstructive Pulmonary Disease

Countries: Russia

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.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

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.

Locations (14)

Blagoveshchensk, Russia
Kazan', Russia
Krasnodar, Russia
Krasnoyarsk, Russia
Moscow, Russia
Nizhny Novgorod, Russia
Novosibirsk, Russia
Omsk, Russia
Rostov-on-Don, Russia
Ryazan, Russia
Saint Petersburg, Russia
Ufa, Russia
Volgograd, Russia
Yekaterinburg, Russia