RecruitingNot Applicable

Clinical and demOgRaphic Features of Patients With Uncontrolled Severe Asthma in Russia (CORSAR)

Russia5,000 participantsStarted 2024-06-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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;
✕

What they're measuring

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

Timeframe: June 2024 - June 2027

To determine the pattern and trends of OCS prescription

Timeframe: June 2024 - June 2027

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

Timeframe: June 2024 - June 2027

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

Timeframe: June 2024 - June 2027

To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean age at the diagnosis of SA will be collected

Timeframe: June 2024 - June 2027

To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of men and women will be calculated

Timeframe: June 2024 - June 2027

Trial details

NCT IDNCT06472310

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-06-30

Contact for this trial

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

View on ClinicalTrials.gov More Severe Asthma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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;
✕

What they're measuring

Timeframe: June 2024 - June 2027

To determine the pattern and trends of OCS prescription

Timeframe: June 2024 - June 2027

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

Timeframe: June 2024 - June 2027

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

Timeframe: June 2024 - June 2027

To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean age at the diagnosis of SA will be collected

Timeframe: June 2024 - June 2027

To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of men and women will be calculated

Timeframe: June 2024 - June 2027