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

NCT06521229 | Recruiting

• 1 other identifier: D2287R00206
• Study Type: observational
• Target: 9,000
• Locations: 1 country
• Sites: 47

Brief 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).

Conditions

Uncontrolled Asthma

Keywords

uncontrolled asthma

Outcome Measures

Primary Outcomes (8)

• 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

  1. Mean age at the inclusion into the study; 2. Mean age at the primary asthma diagnosis; 3. Proportion of men and women; 4. Mean body mass index (BMI); 5. Proportion of patients with overweight (BMI ≥25 kg/m2); 6. Proportion of patients with each educational status (higher, secondary special, secondary general); 7. Proportion of patients from each residential region of Russia; 8. Proportion of patients with negative lifestyle factors: 1. Proportion of patients with history of smoking/current smokers - applicable to smoking tobacco and electronic cigarettes (vapes); 2. Mean smoking index (pack-years) for current (tobacco) smokers; 3. Mean duration of smoking (years) for current e-cigarette (vape) smokers; 4. Proportion of patients with a history of alcohol abuse/current alcohol abuse; 5. Proportion of patient with limitation of physical activity. 9. Proportion of patients with chronic rhinosinusitis with nasal polyps; 10. Proportion of patients with different comorbidities

  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

  16\. Mean FeNO (parts per billion (ppb)) (in case of availability of laboratory data)

  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

  17\. Proportion of patients receiving different classes of drugs for treatment of asthma as reliever and maintenance therapy: 1. SABA alone; 2. ICS alone; 3. LABA alone; 4. ICS and LABA; 5. ICS and SABA; 6. ICS and LABA plus: a) SABA; b) LAMA; c) LTRA; d) Theophylline; e) Macrolide antibiotics. f) ICS and LABA (MART therapy) 18. Proportion of patients with ICS-containing therapy as reliever and as maintenance at baseline; 19. Proportion of patients using SABA reliever for symptoms more than two times a week at baseline; 20. Proportion of patients receiving OCS: intermittent (for exacerbations) / regularly (in the frame of basic therapy); 21. Mean number of OCS treatment courses; 22. Median daily dose in case of regular OCS use; 23. Median cumulative OCS exposure for exacerbations 24. Median cumulative OCS exposure in the frame of basic therapy; 25. Mean baseline parameters of lung function (in case of availability of spirometry data)

  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

  12\. Proportion of patients with different levels of eosinophils blood count (in case of availability of laboratory data): 1. \<150 cells/μl; 2. ≥150 cells/μl; 3. ≥300 cells/μl.

  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

  13\. Mean eosinophils count in sputum (cells per high power field) (in case of availability of laboratory data);

  12 weeks and 52 weeks of retrospective data before visit 1

• To describe the baseline mean total IgE 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

  14\. Mean total IgE (IU/ml) (in case of availability of laboratory data);

  12 weeks and 52 weeks of retrospective data before visit 1

• To describe the baseline Proportion of patients with different levels of total IgE 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

  15\. Proportion of patients with different levels of total IgE (in case of availability of laboratory data)

  12 weeks and 52 weeks of retrospective data before visit 1

• To describe the baseline Mean 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

  11\. Mean eosinophils blood count (cells/μl) (in case of availability of laboratory data);

  12 weeks and 52 weeks of retrospective data before visit 1

Secondary Outcomes (35)

• 1. Proportion of patients with controlled and partly controlled asthma at visit 2 in all patients and in the cohort of patients receiving FDC budesonide/salbutamol

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

• 2. Proportion of patients with changes of inhaled asthma therapy occurred from baseline to visit 2 (in all patients and in the cohort of patients receiving FDC budesonide/salbutamol)

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

• 3. Proportion of patients with OCS prescription occurred from baseline to visit 2 (in all patients and in the cohort of patients receiving FDC budesonide/salbutamol)

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

• 4. Proportion of patients with ICS-containing therapy as reliever and as maintenance at visit 2

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

• 5. Proportion of patients using SABA reliever for symptoms more than two times a week at visit 2 (in all patients and in the cohort of patients receiving FDC budesonide/salbutamol)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

10 000 adult patients with confirmed diagnosis of uncontrolled mild and moderate asthma who receive medical treatment (excluding biological therapy) and are monitored and treated by pulmonologists or allergologists in approximately 70 clinical centers in about 50 regions of Russia

You may qualify if:

• Patients with diagnosis of uncontrolled mild and moderate asthma (according to Global Initiative for Asthma (GINA) score);

You may not qualify if:

• Presence of chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (ILF) currently or in the anamnesis;
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (47)

Research Site

Astrakhan, Russia

RECRUITING

Research Site

Blagoveshchensk, Russia

ACTIVE NOT RECRUITING

Research Site

Bryansk, Russia

RECRUITING

Research Site

Chelyabinsk, Russia

RECRUITING

Research Site

Gatchina, Russia

RECRUITING

Research Site

Irkutsk, Russia

RECRUITING

Research Site

Ivanovo, Russia

RECRUITING

Research Site

Izhevsk, Russia

RECRUITING

Research Site

Kazan', Russia

RECRUITING

Research Site

Kemerovo, Russia

RECRUITING

Research Site

Krasnodar, Russia

RECRUITING

Research Site

Krasnoyarsk, Russia

RECRUITING

Research Site

Lipetsk, Russia

RECRUITING

Research Site

Makhachkala, Russia

RECRUITING

Research Site

Moscow, Russia

RECRUITING

Research Site

Murmansk, Russia

RECRUITING

Research Site

Nal'chik, Russia

RECRUITING

Research Site

Nizhny Novgorod, Russia

ACTIVE NOT RECRUITING

Research Site

Nizhny Tagil, Russia

RECRUITING

Research Site

Novokuznetsk, Russia

RECRUITING

Research Site

Novosibirsk, Russia

RECRUITING

Research Site

Omsk, Russia

RECRUITING

Research Site

Omsk, Russia

ACTIVE NOT RECRUITING

Research Site

Orenburg, Russia

RECRUITING

Research Site

Perm, Russia

RECRUITING

Research Site

Petrozavodsk, Russia

RECRUITING

Research Site

Pyatigorsk, Russia

RECRUITING

Research Site

Rostov-on-Don, Russia

RECRUITING

Research Site

Ryazan, Russia

RECRUITING

Research Site

Saint Petersburg, Russia

RECRUITING

Research Site

Saint Petersburg, Russia

ACTIVE NOT RECRUITING

Research Site

Samara, Russia

RECRUITING

Research Site

Saratov, Russia

RECRUITING

Research Site

Smolensk, Russia

WITHDRAWN

Research Site

Stavropol, Russia

RECRUITING

Research Site

Surgut, Russia

RECRUITING

Research Site

Tomsk, Russia

RECRUITING

Research Site

Tula, Russia

RECRUITING

Research Site

Ufa, Russia

RECRUITING

Research Site

Ulan-Ude, Russia

RECRUITING

Research Site

Verkhnyaya Pyshma, Russia

RECRUITING

Research Site

Vladimir, Russia

RECRUITING

Research Site

Vladivostok, Russia

RECRUITING

Research Site

Voronezh, Russia

RECRUITING

Research Site

Yaroslavl, Russia

RECRUITING

Research Site

Yekaterinburg, Russia

RECRUITING

Research Site

Yuzhno-Sakhalinsk, Russia

RECRUITING

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 25, 2024
• Study Start: June 27, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

RU (47)