An observational study in Severe Asthma, sponsored by AstraZeneca. Recruiting at 40 sites in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by AstraZeneca · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 359 studies in Asthma by AstraZeneca — 19 open to participants now, 28 under way, 8 of them phase 3. Asthma · AstraZeneca.
Among the 359 studies in Asthma by AstraZeneca, this one is the 14th largest by planned enrollment of the 110 observational ones that give a count, is one of 26 that started in 2024, is one of 111 observational ones, reaches primary completion later than 7 of the 27 other live ones, and was the 322nd registered.
4,846 studies on the registry are indexed under Asthma; 602 are open to participants now.
Browse Asthma studies →19 of the 359 studies in Asthma by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in Korea, Republic of
AstraZeneca · Sites in China
AstraZeneca · Sites in United States, Argentina, Austria and 11 more countries
Ages 6+
AstraZeneca · Sites in China
Ages 18–75
AstraZeneca · Sites in United States, Argentina, Czechia and 4 more countries
Ages 4–11
By country, each count listing its studies:
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 146 take children under 18; 104 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
359 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 46 · Phase 2 52 · Phase 3 123 · Phase 4 23
First in 1996; this study’s year is marked. 26 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 5,000 is above the median of 158 across 1,251 observational studies indexed under Asthma.
Median enrollment 175 across the 248 interventional studies, 500 across the 110 observational. Of the 330 that completed or were terminated, 129 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
13 of the studies in Asthma by AstraZeneca that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05692180Phase 3AstraZenecaA Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma | 2026-12-23 |
| NCT06473779Phase 3AstraZenecaOpen-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma. | 2027-06-25 |
| NCT06471257Phase 3AstraZenecaA Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma | 2027-10-04 |
| NCT06307665Phase 3AstraZenecaEvaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma | 2027-10-13 |
| NCT07218172AstraZenecaCharacterization and Clinical Outcomes of Severe Asthma Patients in Israel Treated With Benralizumab (SAIL-B) | 2026-11-30 |
Add all 13 to your calendar (.ics) → With an account.
Among the 359 studies in Asthma by AstraZeneca, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is an observational multicenter cross-sectional study. Planned study population consists of 5 000 adult patients with uncontrolled SA receiving treatment according to standard of care (except biologics). Planned number of study site is 50 outpatient centers with experience of uncontrolled SA treatment in about 50 regions of Russia (in order to describe characteristics of patients with uncontrolled SA in different regions in the most comprehensive way). 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.
There are limited epidemiological data of the patients with uncontrolled severe asthma in Russia since there is no unified system for regular monitoring of patients with severe asthma in the country. 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 severe asthma in particular.
Previously reported observational registries are International Severe Asthma Registry (ISAR) and Russian Severe Asthma Registry (RSAR), both studies included patients regardless of whether patients received biological agents or not. The percentage of patients receiving biologics in these studies was 25.4% and 10.6% respectively.
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 SA 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 SA not receiving biologic therapy.
Trial will have cross-sectional design and will include 1 visit 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 100 patients will be recruited. The total size of study population will be 5 000 patients.
5 000 adult patients with confirmed diagnosis of uncontrolled SA who receive medical treatment (excluding biological therapy) and are monitored and treated by pulmonologists or allergologists in approximately 50 clinical centers in about 50 regions of Russia
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with diagnosis of uncontrolled SA (Asthma Control Questionnaire-5 (ACQ-5) score > 1,5) established no less than 52 weeks prior to inclusion; Severe asthma is defined as asthma, that is controlled due to treatment with ICS in medium or high doses plus LABA and/or ALP, and/or LAMA, and/or systemic (sCS), and/or immunobiological therapy, while attempts to reduce the volume of therapy lead to a loss of symptom control, or asthma remains uncontrolled despite this treatment. Such therapy should be carried out at least 3 months before inclusion.
Uncontrolled asthma is defined as ACQ-5>1.5.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To characterise the profile of routine therapy used for patients with uncontrolled SA not receiving biological therapy in proportion of patients receiving different classes of drugs will be calculated
1. ICS alone (duration, dosage); 2. LABA alone (duration, dosage); 3. ICS and LABA (duration, dosage); 4. ICS and LABA plus: a. Short-acting beta-agonists (SABA) (duration, dosage); b. LAMA (duration, dosage); c. LTRA (duration, dosage); d. Theophylline (duration, dosage); e. Macrolide antibiotics (duration, dosage).
Time frame: June 2024 - June 2027
To determine the pattern and trends of OCS prescription
Proportion of patients receiving OCS: intermittent/regularly; Median daily dose in case of regular OCS use; Median cumulative OCS exposure.
Time frame: June 2024 - June 2027
To describe clinical and demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean age at the inclusion into the study will be collected
Time frame: June 2024 - June 2027
To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean age at the primary asthma diagnosis will be collected
Time frame: June 2024 - June 2027
To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean age at the diagnosis of SA will be collected
Time frame: June 2024 - June 2027
To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of men and women will be calculated
Time frame: June 2024 - June 2027
To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation data on mean body mass index (BMI) will be collected
Time frame: June 2024 - June 2027
To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of patients with overweight will be calculated
BMI ≥25 kg/m2
Time frame: June 2024 - June 2027
To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation data on proportion of patients with different educational statuses
educational statuses: higher, secondary special, secondary general
Time frame: June 2024 - June 2027
To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in proportion of patients from each residential region of Russia will be calculated
Time frame: June 2024 - June 2027
To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of patients with negative lifestyle factors will be calculated
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 limitation of physical activity, related/non-related to asthma; 5. Proportion of patients with overweight (BMI ≥25 kg/m2).
Time frame: June 2024 - June 2027
To describe clinical characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of patients with chronic rhinosinusitis with nasal polyps will be calculated
Proportion of patients with chronic rhinosinusitis with nasal polyps (CRSwNP), overall proportion and: a. Proportions of patients with CRSwNP with different levels of eosinophils blood count: i. \<150 cells/μl; ii. ≥150 cells/μl; iii. ≥300 cells/μl. b. Proportions of patients with CRSwNP with different levels of total IgE: i. ≤30 UI/ml; ii. \>30 UI/ml; c. The proportion of patients with CRSwNP with a history of prior biologic treatment ('any biologic drugs used for asthma treatment in the past'); d. The proportion of patients with CRSwNP who were recommended to start biologic treatment at the first visit ('the need of biological therapy prescription').
Time frame: June 2024 - June 2027
To describe clinical characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of patients with different comorbidities will be calculated
Time frame: June 2024 - June 2027
To describe clinical characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean eosinophils blood count will be collected
cells/μl
Time frame: June 2024 - June 2027
To describe clinical characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of patients with different levels of eosinophils blood count will be calculated
1. \<150 cells/μl; 2. ≥150 cells/μl; 3. ≥300 cells/μl.
Time frame: June 2024 - June 2027
To describe clinical characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation 14. Mean eosinophils count in sputum will be collected
cells per high power field
Time frame: June 2024 - June 2027
To describe clinical characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation 15. Mean total Immunoglobulin E will be calculated
IU/ml
Time frame: June 2024- June 2027
To describe clinical characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of patients with different levels of total IgE will be calculated
1. ≤30 UI/ml; 2. \>30 UI/ml;
Time frame: June 2024 - June 2027
To describe clinical characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean FeNO will be calculated
parts per billion (ppb)
Time frame: June 2024 - June 2027
1. Proportion of patients with change of inhaled therapy during retrospective 52-week follow-up period
1. Change of ICS; 2. Dose of ICS increased; 3. Addition of another drug for inhaled therapy
Time frame: June 2024 - June 2027
2. Proportion of patients with OCS prescription occurred during retrospective 52-week follow-up period
Time frame: June 2024 - June 2027
3. Proportion of participants sent to biological therapy
Time frame: June 2024 - June 2027
4. Proportion of patients experiencing 0, 1, 2, ≥3 severe asthma exacerbations* during retrospective 52-week follow-up period
\*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.
Time frame: June 2024 - June 2027
5. Annualised rate of severe asthma exacerbations* during retrospective 52-week follow-up period
Time frame: June 2024 - June 2027
6. Cumulative days of severe asthma exacerbations
Time frame: June 2024 - June 2027
7. Proportion of patients with healthcare resource utilization (HRU) events during retrospective 52-week follow-up period:
1. Unscheduled outpatient visits; 2. Emergency department visits/emergency calls; 3. Hospitalizations.
Time frame: June 2024 - June 2027
8. Mean parameters of lung function:
1. Mean pre- and post-bronchodilator forced expiratory volume in 1 second (pre- and post-FEV1); 2. Mean pre- and post-bronchodilator forced vital capacity (pre- and post-FVC); 3. Mean pre-bronchodilator forced expiratory flow (pre-FEF); 4. Mean functional residual capacity (FRC), residual lung volume (RLV) and total lung capacity (TLC) evaluated by spirometry and/or body plethysmography.
Time frame: June 2024 - June 2027
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request 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.
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.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Jun 2027, 36 months after the start.
Of 90 industry-sponsored observational studies under Asthma, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 58. This study's planned 36 months is above that.
Counting every sponsor, half of 454 studies reached it within 36 months; a quarter within 18 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.