Uncontrolled AsthmaICEBERGNCT06521229
Clinical& Demographic Profiles of patIents With unControllEd Asthma in Russia: Multi-center oBsErvational ReGistry Study
An observational study of Uncontrolled Asthma, run by AstraZeneca at 44 sites in Russia.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Uncontrolled Asthma
- How many people
- 9,000 participants
- Where
- 44 sitesRussia
- Study dates
- 27 Jun 2024to 30 Sep 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Age ≥ 18 years at the time of inclusion;
- Signed and dated written informed consent in accordance with ICH GCP and local law prior to inclusion in the study;
- Patients with diagnosis of uncontrolled mild and moderate asthma (according to Global Initiative for Asthma (GINA) score);
- Patients with the availability of at least 52 weeks of follow-up data (prior to inclusion) in the medical records.
Who cannot join
- Patients with severe asthma or/and patients receiving any biological therapy currently or within 52 weeks prior to inclusion;
- Presence of chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (ILF) currently or in the anamnesis;
- The participation in any clinical study currently or within 52 weeks prior to inclusion;
- 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.
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
Russia44 sites
Research Site
Astrakhan
Research Site
Blagoveshchensk
Research Site
Bryansk
Research Site
Chelyabinsk
Research Site
Gatchina
Research Site
Irkutsk
Research Site
Ivanovo
Research Site
Izhevsk
Research Site
Kazan'
Research Site
Kemerovo
Research Site
Krasnodar
Research Site
Krasnoyarsk
Research Site
Lipetsk
Research Site
Makhachkala
Research Site
Moscow
Research Site
Murmansk
Research Site
Nal'chik
Research Site
Nizhny Novgorod
Research Site
Nizhny Tagil
Research Site
Novokuznetsk
Research Site
Novosibirsk
Research Site
Omsk
Research Site
Orenburg
Research Site
Perm
Research Site
Petrozavodsk
Research Site
Pyatigorsk
Research Site
Rostov-on-Don
Research Site
Ryazan
Research Site
Saint Petersburg
Research Site
Samara
Research Site
Saratov
Research Site
Stavropol
Research Site
Surgut
Research Site
Tomsk
Research Site
Tula
Research Site
Ufa
Research Site
Ulan-Ude
Research Site
Verkhnyaya Pyshma
Research Site
Vladimir
Research Site
Vladivostok
Research Site
Voronezh
Research Site
Yaroslavl
Research Site
Yekaterinburg
Research Site
Yuzhno-Sakhalinsk
About this study
Official title: An Ambispective Observational Multicenter Registry of Patients With Uncontrolled Asthma in the Population of the Russian Federation
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).
Read the 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 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.
- Conditions
- Uncontrolled Asthma
- Keywords
- uncontrolled asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- Mean age at the inclusion into the study;
- Mean age at the primary asthma diagnosis;
- Proportion of men and women;
- Mean body mass index (BMI);
- Proportion of patients with overweight (BMI ≥25 kg/m2);
- Proportion of patients with each educational status (higher, secondary special, secondary general);
- Proportion of patients from each residential region of Russia;
- Proportion of patients with negative lifestyle factors:
- Proportion of patients with history of smoking/current smokers - applicable to smoking tobacco and electronic cigarettes (vapes);
- Mean smoking index (pack-years) for current (tobacco) smokers;
- Mean duration of smoking (years) for current e-cigarette (vape) smokers;
- Proportion of patients with a history of alcohol abuse/current alcohol abuse;
- Proportion of patient with limitation of physical activity.
- Proportion of patients with chronic rhinosinusitis with nasal polyps;
- Proportion of patients with different comorbidities
Measured: 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
- Mean FeNO (parts per billion (ppb)) (in case of availability of laboratory data)
Measured: 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
- Proportion of patients receiving different classes of drugs for treatment of asthma as reliever and maintenance therapy:
- SABA alone;
- ICS alone;
- LABA alone;
- ICS and LABA;
- ICS and SABA;
- ICS and LABA plus:
- 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)
Measured: 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
- Proportion of patients with different levels of eosinophils blood count (in case of availability of laboratory data):
- <150 cells/μl;
- ≥150 cells/μl;
- ≥300 cells/μl.
Measured: 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
- Mean eosinophils count in sputum (cells per high power field) (in case of availability of laboratory data);
Measured: 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
- Mean total IgE (IU/ml) (in case of availability of laboratory data);
Measured: 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
- Proportion of patients with different levels of total IgE (in case of availability of laboratory data)
Measured: 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
- Mean eosinophils blood count (cells/μl) (in case of availability of laboratory data);
Measured: 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
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.
Measured: 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)
- Change of reliever;
- Change of dose of reliever;
- Change of number of reliever inhalations per day;
- Change of basic therapy drug;
- Change of dose of basic therapy drug;
- Change of number of basic therapy drug inhalations per day;
- Change of ICS;
- Dose of ICS increased;
- Changes of another drug for maintenance therapy.
- Change in the type of drug delivery within the same INN (e.g. from capsule to powder or from aerosol to powder, etc.)
Measured: 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
Measured: 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)
Measured: 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)
- Proportion of patients using SABA reliever for symptoms more than two times a week at visit 1;
- Proportion of patients using SABA reliever for symptoms more than two times a week at visit 2;
- Proportion of patients who were not receiving SABA for symptom relief more than two times a week at baseline at Visit 1 and who began receiving SABA for symptom relief more than two times a week at Visit 2
Measured: 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:
- 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 that required systemic CS.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
- Unscheduled outpatient visits;
- Emergency department visits/emergency calls;
- Hospitalizations
Measured: 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)
- Unscheduled outpatient visits; e. Emergency department visits/emergency calls; f. Hospitalizations.
Measured: 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
- Pre- and post-FEV1 (Forced Expiratory Volume in 1 second). % predicted and L
Measured: 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
- Pre- and post-FVC (Forced Vital Capacity) (L)
Measured: 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
- Pre-FEF (Forced Expiratory Flow). Measured in L/sec.
Measured: 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
Measured: 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);
Measured: 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
Measured: 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
Measured: 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
Measured: 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;
Measured: 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;
Measured: 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;
Measured: 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;
Measured: 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;
Measured: 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;
Measured: 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
- Change of basic therapy drug;
- Change of dose of basic therapy drug;
- Change of number of basic therapy drug inhalations per day;
- Change of ICS;
- Dose of ICS increased;
- Changes of another drug for maintenance therapy;
- Change in the type of drug delivery within the same INN (e.g. from capsule to powder or from aerosol to powder, etc.).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
- Unscheduled outpatient visits;
- Emergency department visits/emergency calls;
- Hospitalizations.
Measured: 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
Measured: 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
Measured: 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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start27 Jun 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 9,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521229
- Sponsor's protocol ID
- D2287R00206
- Acronym
- ICEBERG
- Status last verified
- Sep 2026
- First submitted
- 21 Jun 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.