COPD patients with frequent flare-ups in Moscow

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

We will collect medical history and treatment details to see if real-world care relates to outcomes for adults in Moscow with moderate-to-very severe COPD who have frequent flare-ups.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Locations: 1 site (Moscow)
• Trial ID: NCT07307781 on ClinicalTrials.gov

What this trial studies

This is an ambispective, non-interventional registry combining a retrospective 52-week chart review with a 24-week prospective follow-up to document treatments and outcomes in outpatients with frequent COPD exacerbations. At baseline, physicians will record past-year clinical history and treatments, and at Week 24 patients will have a follow-up interview and physician assessment; all data will be entered into an electronic case report form from routine clinical records. Up to 500 patients will be enrolled over about 12 months at a Moscow site, with the overall study lasting roughly 25 months. No experimental treatments are given and patient management follows routine clinical practice.

Who should consider this trial

Good fit: Adults (≥18) with spirometry-confirmed moderate-to-very severe (GOLD 2–4) COPD who had ≥2 moderate or ≥1 severe exacerbations in the past year and have been on dual inhaled maintenance therapy for at least 6 weeks, who can attend the Moscow site and give informed consent.

Not a fit: Patients recently treated with triple inhaled therapy, those with alpha-1-antitrypsin deficiency, bronchiectasis, interstitial lung disease or other excluded lung conditions, and people without frequent exacerbations are unlikely to benefit from this registry's findings.

Why it matters

Potential benefit: If successful, findings could help clinicians identify real-world treatment patterns tied to better outcomes and inform care decisions for people with frequent COPD exacerbations.

How similar studies have performed: Similar observational registries have been used internationally to link treatment patterns with exacerbation outcomes in COPD, so this approach is established and has produced useful real-world insights.

Eligibility criteria

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. Confirmed diagnosis of moderate-to-very severe (GOLD 2-4) COPD established by spirometry demonstrating a post-bronchodilator ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) \<0.7 obtained outside an exacerbation;
4. ≥2 moderate or ≥1 severe COPD exacerbations in previous 52 weeks;
5. Dual inhaled maintenance therapy (LABA/LAMA, ICS/LAMA, or ICS/LABA) for at least 6 weeks prior to screening

Exclusion Criteria:

1. Current or previous treatment with triple combination (ICS/LAMA/LABA) as maintenance therapy within 52 weeks prior to screening visit;
2. COPD due to documented alpha-1-antitrypsin deficiency;
3. A diagnosis of bronchiectasis, sarcoidosis, interstitial lung diseases, or idiopathic pulmonary fibrosis, exacerbation of 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 interventional clinical study currently or within 52 weeks prior to inclusion; participation in non-interventional, observational registries without protocol-driven treatment changes does not constitute an exclusion

Where this trial is running

Moscow

• Research Site — Moscow, Russia (Recruiting)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Chronic Obstructive Pulmonary Disease; chronic obstructive pulmonary disease