Study of Patient With Frequent COPD Exacerbations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-16

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Patient With Frequent Exacerbations in Moscow

NCT07307781

Chronic Obstructive Pulmonary Disease (COPD)

NOT_YET_RECRUITING

Exacerbations and Their Outcomes International (EXACOS International)

NCT04928417

Chronic Obstructive Pulmonary Disease

COMPLETED

Treatment and Exacerbation in COPD Subjects

NCT03375450

Comparative Effectiveness Study

COMPLETED

Safety & Efficacy of BCT197A2201 in COPD Patients Presenting With an Exacerbation

NCT01332097

Chronic Obstructive Pulmonary Disease

COMPLETED PHASE2

Study to Assess the Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT00690482

Moderate to Severe COPD

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study consists of a retrospective phase covering 52 weeks and a prospective phase of 24 weeks, involving 2000 patients across approximately 35 cites. Therefore, the aim of the study is to evaluate the clinical and demographic patients' characteristics based on retrospective part and COPD treatment patterns based on prospective part of patients with frequent exacerbations of COPD on dual therapy in the Russian Federation. The study results will be interpreted in the context of an open label, single arm study design. Due to the limited data available on the COPD population in Russia, the characterization of clinical and demographic characteristic of patients based on the retrospective component of the study will enhance the understanding of this patient group and the prospective aspect, which analyses therapeutic approaches, will help to assess physicians' adherence to current recommendations regarding therapy selection for COPD patients on dual therapy with frequent exacerbations.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age ≥ 18 years at the time of inclusion;
2. Signed and dated written informed consent in accordance with ICH-GCP and local law prior to inclusion in the study;
3. Patients with diagnosed moderate-to-severe COPD (see comments below);
4. ≥2 moderate or ≥1 severe COPD exacerbations in previous 52 weeks (see comments below);
5. Patients have been receiving two inhaled maintenance therapies (LABA/LAMA, ICS/LABA, ICS/LAMA) for at least 6 weeks prior to inclusion.

Exclusion Criteria

1. Current or previous treatment with triple combination (ICS/LABA/LAMA) within 52 weeks prior to inclusion;
2. COPD due to documented α-1 antitrypsin deficiency;
3. 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;
4. The participation in any clinical study currently or within 52 weeks prior to inclusion.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No