RecruitingNCT07221981

Study of Patient With Frequent COPD Exacerbations

Clinical and dEmographic chaRacteristics of Patients With Frequent COPD Exacerbations and Evaluation of Therapeutic Approaches in Treatment in RussiA

Sponsor

AstraZeneca

Enrollment

2,000 participants

Start Date

Dec 16, 2024

Study Type

OBSERVATIONAL

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Summary

This Study is a multicenter, non-interventional, observational, ambispective (retrospective-prospective) study to evaluate clinical and demographic characteristics, approaches to therapy in outpatients with COPD and frequent exacerbations in the Russian Federation. Planned number of Study site is 35 outpatient centers with experience of treatment of COPD with frequency exacerbations in about 30 regions in Russia.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria5

Age ≥ 18 years at the time of inclusion;
Signed and dated written informed consent in accordance with ICH-GCP and local law prior to inclusion in the study;
Patients with diagnosed moderate-to-severe COPD (see comments below);
≥2 moderate or ≥1 severe COPD exacerbations in previous 52 weeks (see comments below);
Patients have been receiving two inhaled maintenance therapies (LABA/LAMA, ICS/LABA, ICS/LAMA) for at least 6 weeks prior to inclusion.

Exclusion Criteria4

Current or previous treatment with triple combination (ICS/LABA/LAMA) within 52 weeks prior to inclusion;
COPD due to documented α-1 antitrypsin deficiency;
A diagnosis of bronchiectasis, sarcoidosis, interstitial lung diseases, or idiopathic pulmonary fibrosis, exacerbation of bronchial asthma or any acute or chronic disease that, as deemed by Investigator, limits the ability of patients to participate in this study or could influence the interpretation of the results;
The participation in any clinical study currently or within 52 weeks prior to inclusion.