Clinical and demOgRaphic Features of Patients With Uncontrolled Severe Asthma in Russia (CORSAR)
ConditionSevere Asthma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
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
This trial does not accept healthy volunteersQualifiers
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 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.
Patients with the availability of at least 52 weeks of follow-up data (prior to inclusion) in the medical records.
Disqualifiers
Patients receiving any biological therapy currently or within 52 weeks prior to inclusion;
Presence of chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (ILF) currently or in the anamnesis;
The participation in any clinical study currently or within 52 weeks prior to inclusion;
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.
Trial population
5 000 adult patients with confirmed diagnosis of uncontrolled SA who receive medical treatment (excluding biological therapy) and are monitored and treated by pulmonologists or allergologists in approximately 50 clinical centers in about 50 regions of Russia
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
To characterise the profile of routine therapy used for patients with uncontrolled SA not receiving biological therapy in proportion of patients receiving different classes of drugs will be calculated
1. ICS alone (duration, dosage); 2. LABA alone (duration, dosage); 3. ICS and LABA (duration, dosage); 4. ICS and LABA plus: a. Short-acting beta-agonists (SABA) (duration, dosage); b. LAMA (duration, dosage); c. LTRA (duration, dosage); d. Theophylline (duration, dosage); e. Macrolide antibiotics (duration, dosage).
Time frame
June 2024 - June 20272
To determine the pattern and trends of OCS prescription
Proportion of patients receiving OCS: intermittent/regularly; Median daily dose in case of regular OCS use; Median cumulative OCS exposure.
Time frame
June 2024 - June 20273
To describe clinical and demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean age at the inclusion into the study will be collected
Time frame
June 2024 - June 20274
To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean age at the primary asthma diagnosis will be collected
Time frame
June 2024 - June 2027Secondary outcomes
1
1. Proportion of patients with change of inhaled therapy during retrospective 52-week follow-up period
1. Change of ICS; 2. Dose of ICS increased; 3. Addition of another drug for inhaled therapy
Time frame
June 2024 - June 20272
2. Proportion of patients with OCS prescription occurred during retrospective 52-week follow-up period
Time frame
June 2024 - June 20273
3. Proportion of participants sent to biological therapy
Time frame
June 2024 - June 20274
4. Proportion of patients experiencing 0, 1, 2, ≥3 severe asthma exacerbations* during retrospective 52-week follow-up period
\*Severe asthma exacerbation is defined as worsening of asthma requiring any of the following: * use of systemic corticosteroids (CS) (or a temporary increase in a stable OCS background dose) for at least 3 days or a single depo-injectable dose of CS and/or * an emergency room/urgent care visit (defined as evaluation and treatment for \< 24 hours in an emergency department or urgent care center) due to asthma that required systemic CS (as per above) and/or * an inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥ 24 hours) due to asthma.
Time frame
June 2024 - June 2027Sponsors and contacts
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Source ClinicalTrials.gov