RecruitingNot Applicable

Clinical& Demographic Profiles of patIents With unControllEd Asthma in Russia: Multi-center oBsErvational ReGistry Study

Russia9,000 participantsStarted 2024-06-27

Plain-language summary

This study is a multi-centre, non-interventional, observational, ambispective registry. Planned study population consists of 9 000 adult patients with uncontrolled asthma receiving treatment according to standard of care (except biologics). Planned number of study site is 70 outpatient centers with experience of uncontrolled asthma treatment in about 50 regions of Russia (in order to describe characteristics of patients with uncontrolled asthma in different regions in the most comprehensive way).

Who can participate

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 mild and moderate asthma (according to Global Initiative for Asthma (GINA) score);
✓. Patients with the availability of at least 52 weeks of follow-up data (prior to inclusion) in the medical records.

Exclusion criteria

✕. Patients with severe asthma or/and 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.

What they're measuring

To describe the baseline demographic characteristics of outpatients with uncontrolled asthma in the Russian Federation in all patients and in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2

Timeframe: 12 weeks (also 52 weeks of retrospective data before visit 1)

To describe the baseline clinical characteristics of outpatients with uncontrolled asthma in the Russian Federation in all patients and in the cohort of patients receiving FDC budesonide/salbutamol on Visit 2

Timeframe: 12 weeks and 52 weeks of retrospective data before visit 1

To characterise the profile of routine therapy used for outpatients with uncontrolled asthma in the Russian Federation in all patients and in the cohort of patients receiving FDC budesonide/salbutamol on Visit 2

Timeframe: 12 weeks (also 52 weeks of retrospective data before visit 1)

To describe the baseline eosinophils blood count of outpatients with uncontrolled asthma in the Russian Federation in all patients and in the cohort of patients receiving FDC budesonide/salbutamol on Visit 2

Timeframe: 12 weeks and 52 weeks of retrospective data before visit 1

To describe the baseline mean eosinophils count in sputum of outpatients with uncontrolled asthma in the Russian Federation in all patients and in the cohort of patients receiving FDC budesonide/salbutamol on Visit 2

Timeframe: 12 weeks and 52 weeks of retrospective data before visit 1

Trial details

NCT IDNCT06521229

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-09-30

Contact for this trial

AstraZeneca Clinical Study Information Center

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

View on ClinicalTrials.gov More Uncontrolled Asthma trials

Plain-language summary

Who can participate

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 mild and moderate asthma (according to Global Initiative for Asthma (GINA) score);
✓. Patients with the availability of at least 52 weeks of follow-up data (prior to inclusion) in the medical records.

Exclusion criteria

✕. Patients with severe asthma or/and 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.

What they're measuring

Timeframe: 12 weeks (also 52 weeks of retrospective data before visit 1)

Timeframe: 12 weeks and 52 weeks of retrospective data before visit 1

Timeframe: 12 weeks (also 52 weeks of retrospective data before visit 1)

Timeframe: 12 weeks and 52 weeks of retrospective data before visit 1