COPD patients with frequent flare-ups in Moscow

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Research Site
  Moscow, Russia Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.