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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).
There are limited epidemiological data of the patients with uncontrolled asthma in Russia. The systematic information about complications and comorbidities, about the treatment approaches and their effectiveness in the Russian population is also absent.
The observational registry is really important to describe the epidemiological characteristics of the disease and to analyse the clinical characteristics of the various subgroups of patients. This is an excellent starting point to be able to investigate the characteristics of the disease in detail.
The Russian Federation consists of 85 regions with a total population of more than 145 million people. The regions differ in ethnic composition, age, gender, climate, ecology, economic level, prevalence of asthma in general and uncontrolled asthma in particular.
Thus, there is a need to perform a large-scale observational registry in regions of the country with a sufficient size of population to obtain information on uncontrolled asthma epidemiology, clinical and demographic characteristics, to describe main clinical outcomes and evaluate existing associations between observed treatment patterns and clinical outcomes in real clinical practice in patients with uncontrolled asthma not receiving biologic therapy.
Trial will have ambispective design and will include 2 visits for obtaining the patient's demographic and clinical data. To allow wide data coverage the study will involve at least 50 regions of Russian Federation; in each region 200 patients will be recruited. The total size of study population will be 9 000 patients.
All data will be collected during 2-3 visits carried out according to routine clinical practice for observation and treatment of patients with uncontrolled asthma. At visit 1, baseline data of 52 weeks prior to inclusion will be collected by physician based on the patient's medical records and interview during the visit. Visit 2 (final visit) will be conducted after 12 weeks (±7 days) in order to collect follow-up data which coincides with the recommended dates. Information on changes in the treatment of uncontrolled asthma and on clinical outcomes will be collected.
For the cohort of patients receiving fixed-dose combination budesonide/salbutamol on Visit 2, an additional follow-up visit (Visit 3) will be conducted in 12 weeks (±14 days) after Visit 2, in order to collect data which coincides with the recommended dates. Information on changes in the treatment of uncontrolled asthma and on clinical outcomes will be collected. It is planned to enroll 500 patients receiving fixed-dose combination budesonide/salbutamol on Visit 2, to whom the follow-up visit (Visit 3) will be conducted.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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:
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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Astrakhan | Russia | |||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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.
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.
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| 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):
| 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 |
| 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) | 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 | (in all patients and in the cohort of patients receiving FDC budesonide/salbutamol) | 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) |
| 6. Proportion of patients experiencing 0, 1, 2, ≥3 severe asthma exacerbations (in all patients and in the cohort of patients receiving FDC budesonide/salbutamol) | Severe asthma exacerbation is defined as worsening of asthma requiring any of the following:
| during 52 weeks prior to inclusion |
| 7. Annualised rate of severe asthma exacerbations (in all patients and in the cohort of patients receiving FDC budesonide/salbutamol) | during 52 weeks prior to inclusion |
| 8. Cumulative days of severe asthma exacerbations (in all patients and in the cohort of patients receiving FDC budesonide/salbutamol) | during 52 weeks prior to inclusion |
| 9. Proportion of patients experiencing 0, 1, 2, ≥3 severe asthma exacerbations (in all patients and in the cohort of patients receiving FDC budesonide/salbutamol) | 12 weeks |
| 10. Proportion of patients with healthcare resource utilization (HRU) events (in all patients and in the cohort of patients receiving FDC budesonide/salbutamol) |
| during 52 weeks prior to inclusion |
| 11. Proportion of patients with HRU events (in all patients and in the cohort of patients receiving FDC budesonide/salbutamol) | 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) in all patients and in the cohort of patients receiving FDC budesonide/salbutamol | 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) in all patients and in the cohort of patients receiving FDC budesonide/salbutamol | 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) in all patients and in the cohort of patients receiving FDC budesonide/salbutamol | c. Pre-FEF (Forced Expiratory Flow). Measured in L/sec. | 12 weeks |
| Proportion of patients with controlled and partlly controlled asthma (in all patients and in the cohort of patients receiving FDC budesonide/salbutamol) | 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 |
| To describe the Proportion of patients with history of smoking/current smokers at visit 3 in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2 | applicable to smoking tobacco and electronic cigarettes (vapes)), and proportion of patients with change of smoking status at visit 3 compared to baseline (non-smoker/former smoker switched to current smoker, current smoker switched to former smoker); | 24 weeks |
| To describe mean smoking index for current (tobacco) smokers, according to the assessment at visit 3 in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2 | Mean smoking index to be evaluated in pack-years | 24 weeks |
| To describe mean duration of smoking (years) for current e-cigarette (vape) smokers in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2 | according to the assessment at visit 3 | 24 weeks |
| To describe change of body mass index (BMI) to visit 3 compared to baseline in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2 | according to the assessment at visit 3 | 24 weeks |
| To describe proportion with overweight (BMI ≥25 kg/m2) in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2 | assessment at visit 3; | 24 weeks |
| To describe Change of body mass index (BMI) to visit 3 compared to baseline in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2 | assessment at visit 3; | 24 weeks |
| To describe proportion of patients with controlled and partly controlled asthma (according to GINA score) at visit 3 in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2 | assessment at visit 3; | 24 weeks |
| To describe Proportion of patients with controlled and partly controlled asthma (according to the questionnaire ACQ-5) at visit 3 in the cohort of patients receiving FDC budesonide/salbutamol on Visit 2 | assessment at visit 3; | 24 weeks |
| To describe Proportion of patients receiving FDC budesonide/salbutamol as monotherapy or in combination with basic therapy in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2 | assessment at visit 3; | 24 weeks |
| To describe Asthma therapy regimen from which the patient was switched to the FDC budesonide/salbutamol in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2 | assessment at visit 3; | 24 weeks |
| To describe Proportion of patients with changes of inhaled asthma therapy occurred from visit 2 to visit 3 in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2 |
| 24 weeks |
| To describe Proportion of patients with OCS prescription occurred from visit 2 to visit 3; for patients already used OCS at visit 2 dose change will be evaluated in the cohort of patients receiving FDC budesonide/salbutamol on Visit 2 | assessment at Visit 3 | 24 weeks |
| To describe Proportion of patients with ICS-containing therapy as reliever and as maintenance at visit 3 in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2 | assessment at Visit 3 | 24 weeks |
| To describe number of budesonide/salbutamol inhalers used between visit 2 and visit 3 in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2 | assessment at Visit 3 | 24 weeks |
| To describe number of budesonide/salbutamol inhalations per month for a period from visit 2 to visit 3 in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2 | assessment at Visit 3 | 24 weeks |
| To describe proportion of patients experiencing 0, 1, 2, ≥3 severe asthma exacerbations* between visit 2 and visit 3 in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2 | assessment at Visit 3 | 24 weeks |
| To describe proportion of patients with HRU events occurred between visit 2 and visit 3 in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2 |
| 24 weeks |
| To describe change from Visit 2 Pre- and post-FEV1 at visit 3 (in case of availability of spirometry data) in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2 | assessment at Visit 3 | 24 weeks |
| To describe change from Visit 2 Pre- and post-FVC at visit 3 (in case of availability of spirometry data) in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2 | assessment at Visit 3 | 24 weeks |
| To describe change from Visit Pre-FEF at visit 3 (in case of availability of spirometry data) in the cohort of patients receiving fixed-dose combination (FDC) budesonide/salbutamol on Visit 2 | assessment at Visit 3 | 24 weeks |
| Active, not recruiting |
| Blagoveshchensk |
| Russia |
| Research Site | Recruiting | Bryansk | Russia |
| Research Site | Recruiting | Chelyabinsk | Russia |
| Research Site | Recruiting | Gatchina | Russia |
| Research Site | Recruiting | Irkutsk | Russia |
| Research Site | Recruiting | Ivanovo | Russia |
| Research Site | Recruiting | Izhevsk | Russia |
| Research Site | Recruiting | Kazan' | Russia |
| Research Site | Recruiting | Kemerovo | Russia |
| Research Site | Recruiting | Krasnodar | Russia |
| Research Site | Recruiting | Krasnoyarsk | Russia |
| Research Site | Recruiting | Lipetsk | Russia |
| Research Site | Recruiting | Makhachkala | Russia |
| Research Site | Recruiting | Moscow | Russia |
| Research Site | Recruiting | Murmansk | Russia |
| Research Site | Recruiting | Nal'chik | Russia |
| Research Site | Active, not recruiting | Nizhny Novgorod | Russia |
| Research Site | Recruiting | Nizhny Tagil | Russia |
| Research Site | Recruiting | Novokuznetsk | Russia |
| Research Site | Recruiting | Novosibirsk | Russia |
| Research Site | Recruiting | Omsk | Russia |
| Research Site | Active, not recruiting | Omsk | Russia |
| Research Site | Recruiting | Orenburg | Russia |
| Research Site | Recruiting | Perm | Russia |
| Research Site | Recruiting | Petrozavodsk | Russia |
| Research Site | Recruiting | Pyatigorsk | Russia |
| Research Site | Recruiting | Rostov-on-Don | Russia |
| Research Site | Recruiting | Ryazan | Russia |
| Research Site | Recruiting | Saint Petersburg | Russia |
| Research Site | Active, not recruiting | Saint Petersburg | Russia |
| Research Site | Recruiting | Samara | Russia |
| Research Site | Recruiting | Saratov | Russia |
| Research Site | Withdrawn | Smolensk | Russia |
| Research Site | Recruiting | Stavropol | Russia |
| Research Site | Recruiting | Surgut | Russia |
| Research Site | Recruiting | Tomsk | Russia |
| Research Site | Recruiting | Tula | Russia |
| Research Site | Recruiting | Ufa | Russia |
| Research Site | Recruiting | Ulan-Ude | Russia |
| Research Site | Recruiting | Verkhnyaya Pyshma | Russia |
| Research Site | Recruiting | Vladimir | Russia |
| Research Site | Recruiting | Vladivostok | Russia |
| Research Site | Recruiting | Voronezh | Russia |
| Research Site | Recruiting | Yaroslavl | Russia |
| Research Site | Recruiting | Yekaterinburg | Russia |
| Research Site | Recruiting | Yuzhno-Sakhalinsk | Russia |