Clinical& Demographic Profiles of patIents With unControllEd Asthma in Russia: Multi-center oBsErvational ReGistry Study
NCT Number: NCT06521229
Acronym: ICEBERG
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Uncontrolled Asthma
Sponsor: AstraZeneca
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-27
Completion Date: 2026-03-31
Locations: Research Site, Blagoveshchensk, Russian Federation|Research Site, Chelyabinsk, Russian Federation|Research Site, Nalchik, Russian Federation|Research Site, Nizhny Novgorod, Russian Federation|Research Site, Orenburg, Russian Federation|Research Site, Saint Petersburg, Russian Federation|Research Site, Samara, Russian Federation|Research Site, Saratov, Russian Federation|Research Site, Tomsk, Russian Federation|Research Site, Voronezh, Russian Federation|Research Site, Yekaterinburg, Russian Federation

Summary:
This study is a multi-centre, non-interventional, observational, ambispective registry. Planned study population consists of 10 000 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).

Primary Outcome Measures: To describe the baseline demographic characteristics of outpatients with uncontrolled asthma in the Russian Federation, 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;
   2. Mean smoking index (pack-years) for current smokers;
   3. Proportion of patients with a history of alcohol abuse/current alcohol abuse;
   4. Proportion of patients with overeating;
   5. Proportion of patient with physical inactivity.
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, 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, 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. 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/regularly; 21. Mean number of OCS treatment courses; 22. Median daily dose in case of regular OCS use; 23. Median cumulative OCS exposure; 24. 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 clinical characteristics of outpatients with uncontrolled asthma in the Russian Federation, 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 clinical characteristics of outpatients with uncontrolled asthma in the Russian Federation, 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 clinical characteristics of outpatients with uncontrolled asthma in the Russian Federation, 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 clinical characteristics of outpatients with uncontrolled asthma in the Russian Federation, 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 clinical characteristics of outpatients with uncontrolled asthma in the Russian Federation, 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 Outcome Measures: 1. Proportion of patients with controlled and partly controlled asthma at visit 2, according to GINA (Global Initiative for Asthma) score. GINA assessment of asthma control consists of 4 questions, the higher the score the worse asthma control is., 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:, 1. Change of reliever;
2. Change of dose of reliever;
3. Change of number of reliever inhalations per day;
4. Change of ICS;
5. Dose of ICS increased;
6. Changes of another drug for maintenance therapy., 12 weeks (also 52 weeks of retrospective data before visit 1)|3. Proportion of patients with OCS prescription occurred from baseline to visit 2, for patients already used OCS at baseline dose change will be evaluated, 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, 12 weeks (also 52 weeks of retrospective data before visit 1)|6. Proportion of patients experiencing 0, 1, 2, ≥3 severe asthma exacerbations, 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., during 52 weeks prior to inclusion|7. Annualised rate of severe asthma exacerbations*, during 52 weeks prior to inclusion|8. Cumulative days of severe asthma exacerbations*, during 52 weeks prior to inclusion|9. Proportion of patients experiencing 0, 1, 2, ≥3 severe asthma exacerbations*, 12 weeks|10. Proportion of patients with healthcare resource utilization (HRU) events, 1. Unscheduled outpatient visits;
2. Emergency department visits/emergency calls;
3. Hospitalizations, during 52 weeks prior to inclusion|11. Proportion of patients with HRU events, d. Unscheduled outpatient visits; e. Emergency department visits/emergency calls; f. Hospitalizations., 12 weeks|12.a Change from baseline in mean parameters of lung function at visit 2 (in case of availability of spirometry data):, a. Pre- and post-FEV1 (Forced Expiratory Volume in 1 second). % predicted and L, 12 weeks|12.b Change from baseline in mean parameters of lung function at visit 2 (in case of availability of spirometry data):, b. Pre- and post-FVC (Forced Vital Capacity) (L), 12 weeks|12.c Change from baseline in mean parameters of lung function at visit 2 (in case of availability of spirometry data):, c. Pre-FEF (Forced Expiratory Flow). Measured in L/sec., 12 weeks|Proportion of patients with controlled and partlly controlled asthma, according to the bronchial asthma symptom control questionnaire (ACQ-5). Uncontrolled asthma is defined as \>1.5 points according to the Asthma Symptom Control Questionnaire (ACQ-5). The higher the score, the worse, at inclusion into the study, then in 3 months (+-7days) after the inclusion