Clinical trial NCT06521229: Clinical& Demographic Profiles of patIents With unControllEd Asthma in Russia: Multi-center oBsErvational ReGistry Study
Official title: An Ambispective Observational Multicenter Registry of Patients With Uncontrolled Asthma in the Population of the Russian Federation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uncontrolled Asthma
Keywords: uncontrolled asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-07-25
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
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

Brief 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).

Detailed description: 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 10 000 patients.

All data will be collected during 2 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 3 months 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years at the time of inclusion;
2. Signed and dated written informed consent in accordance with ICH GCP and local law prior to inclusion in the study;
3. Patients with diagnosis of uncontrolled mild and moderate asthma (according to Global Initiative for Asthma (GINA) score);
4. Patients with the availability of at least 52 weeks of follow-up data (prior to inclusion) in the medical records.

Exclusion Criteria:

1. Patients with severe asthma or/and patients receiving any biological therapy currently or within 52 weeks prior to inclusion;
2. Presence of chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (ILF) currently or in the anamnesis;
3. The participation in any clinical study currently or within 52 weeks prior to inclusion;
4. 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.

Primary outcomes:
measure: To describe the baseline demographic characteristics of outpatients with uncontrolled asthma in the Russian Federation
timeFrame: 12 weeks (also 52 weeks of retrospective data before visit 1)
measure: To describe the baseline clinical characteristics of outpatients with uncontrolled asthma in the Russian Federation
timeFrame: 12 weeks and 52 weeks of retrospective data before visit 1
measure: To characterise the profile of routine therapy used for outpatients with uncontrolled asthma in the Russian Federation
timeFrame: 12 weeks (also 52 weeks of retrospective data before visit 1)
measure: To describe the baseline clinical characteristics of outpatients with uncontrolled asthma in the Russian Federation
timeFrame: 12 weeks and 52 weeks of retrospective data before visit 1
measure: To describe the baseline clinical characteristics of outpatients with uncontrolled asthma in the Russian Federation
timeFrame: 12 weeks and 52 weeks of retrospective data before visit 1
measure: To describe the baseline clinical characteristics of outpatients with uncontrolled asthma in the Russian Federation
timeFrame: 12 weeks and 52 weeks of retrospective data before visit 1
measure: To describe the baseline clinical characteristics of outpatients with uncontrolled asthma in the Russian Federation
timeFrame: 12 weeks and 52 weeks of retrospective data before visit 1
measure: To describe the baseline clinical characteristics of outpatients with uncontrolled asthma in the Russian Federation
timeFrame: 12 weeks and 52 weeks of retrospective data before visit 1
Secondary outcomes:
measure: 1. Proportion of patients with controlled and partly controlled asthma at visit 2
timeFrame: 12 weeks (also 52 weeks of retrospective data before visit 1)
measure: 2. Proportion of patients with changes of inhaled asthma therapy occurred from baseline to visit 2:
timeFrame: 12 weeks (also 52 weeks of retrospective data before visit 1)
measure: 3. Proportion of patients with OCS prescription occurred from baseline to visit 2
timeFrame: 12 weeks (also 52 weeks of retrospective data before visit 1)
measure: 4. Proportion of patients with ICS-containing therapy as reliever and as maintenance at visit 2
timeFrame: 12 weeks (also 52 weeks of retrospective data before visit 1)
measure: 5. Proportion of patients using SABA reliever for symptoms more than two times a week at visit 2
timeFrame: 12 weeks (also 52 weeks of retrospective data before visit 1)
measure: 6. Proportion of patients experiencing 0, 1, 2, ≥3 severe asthma exacerbations
timeFrame: during 52 weeks prior to inclusion
measure: 7. Annualised rate of severe asthma exacerbations*
timeFrame: during 52 weeks prior to inclusion
measure: 8. Cumulative days of severe asthma exacerbations*
timeFrame: during 52 weeks prior to inclusion
measure: 9. Proportion of patients experiencing 0, 1, 2, ≥3 severe asthma exacerbations*
timeFrame: 12 weeks
measure: 10. Proportion of patients with healthcare resource utilization (HRU) events
timeFrame: during 52 weeks prior to inclusion
measure: 11. Proportion of patients with HRU events
timeFrame: 12 weeks
measure: 12.a Change from baseline in mean parameters of lung function at visit 2 (in case of availability of spirometry data):
timeFrame: 12 weeks
measure: 12.b Change from baseline in mean parameters of lung function at visit 2 (in case of availability of spirometry data):
timeFrame: 12 weeks
measure: 12.c Change from baseline in mean parameters of lung function at visit 2 (in case of availability of spirometry data):
timeFrame: 12 weeks
measure: Proportion of patients with controlled and partlly controlled asthma
timeFrame: at inclusion into the study, then in 3 months (+-7days) after the inclusion
Other outcomes:
Locations:
city: Astrakhan
country: Russian Federation
facility: Research Site
city: Blagoveshchensk
country: Russian Federation
facility: Research Site
city: Bryansk
country: Russian Federation
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Gatchina
country: Russian Federation
facility: Research Site
city: Irkutsk
country: Russian Federation
facility: Research Site
city: Ivanovo
country: Russian Federation
facility: Research Site
city: Izhevsk
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Lipetsk
country: Russian Federation
facility: Research Site
city: Makhachkala
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Murmansk
country: Russian Federation
facility: Research Site
city: Nalchik
country: Russian Federation
facility: Research Site
city: Nizhny Novgorod
country: Russian Federation
facility: Research Site
city: Nizhny Novgorod
country: Russian Federation
facility: Research Site
city: Nizhny Tagil
country: Russian Federation
facility: Research Site
city: Novokuznetsk
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Orenburg
country: Russian Federation
facility: Research Site
city: Petrozavodsk
country: Russian Federation
facility: Research Site
city: Pyatigorsk
country: Russian Federation
facility: Research Site
city: Rostov-on-Don
country: Russian Federation
facility: Research Site
city: Ryazan
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: Smolensk
country: Russian Federation
facility: Research Site
city: Stavropol
country: Russian Federation
facility: Research Site
city: Surgut
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Tula
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Ulan-Ude
country: Russian Federation
facility: Research Site
city: Verkhnyaya Pyshma
country: Russian Federation
facility: Research Site
city: Vladimir
country: Russian Federation
facility: Research Site
city: Vladivostok
country: Russian Federation
facility: Research Site
city: Voronezh
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Yekaterinburg
country: Russian Federation
facility: Research Site
city: Yekaterinburg
country: Russian Federation
facility: Research Site
city: Yuzhno-Sakhalinsk
country: Russian Federation
facility: Research Site
Study officials:
References: