NCT06472310 Clinical and demOgRaphic Features of Patients With Uncontrolled Severe Asthma in Russia (CORSAR)
| NCT ID | NCT06472310 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AstraZeneca |
| Condition | Severe Asthma |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2024-06-06 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2024-06-06 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is an observational multicenter cross-sectional study. Planned study population consists of 5 000 adult patients with uncontrolled SA receiving treatment according to standard of care (except biologics). Planned number of study site is 50 outpatient centers with experience of uncontrolled SA treatment in about 50 regions of Russia (in order to describe characteristics of patients with uncontrolled SA in different regions in the most comprehensive way). This non-interventional study does not imply any intervention into a routine clinical practice, and does not provide for any diagnostic and therapeutic procedures other than those used in routine practice.
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. Patients with diagnosis of uncontrolled SA (Asthma Control Questionnaire-5 (ACQ-5) score \> 1,5) established no less than 52 weeks prior to inclusion; Severe asthma is defined as asthma, that is controlled due to treatment with ICS in medium or high doses plus LABA and/or ALP, and/or LAMA, and/or systemic corticosteroids (sCS), and/or immunobiological therapy, while attempts to reduce the volume of therapy lead to a loss of symptom control, or asthma remains uncontrolled despite this treatment. Such therapy should be carried out at least 3 months before inclusion. Uncontrolled asthma is defined as ACQ-5\>1.5. 4. Patients with the availability of at least 52 weeks of follow-up data (prior to inclusion) in the medical records. Exclusion Criteria: 1. Patients receiving any biological therapy currently or within 52 weeks prior to inclusion; 2. Presence of chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (ILF) currently or in the anamnesis; 3. The participation in any clinical study currently or within 52 weeks prior to inclusion; 4. An 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06472310 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Severe Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06472310 currently recruiting?
Yes, NCT06472310 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT06472310 trial being conducted?
This trial is being conducted at Astrakhan, Russia, Barnaul, Russia, Blagoveshchensk, Russia, Bryansk, Russia and 11 additional locations.
Who is sponsoring the NCT06472310 clinical trial?
NCT06472310 is sponsored by AstraZeneca. The trial plans to enroll 5,000 participants.
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