Clinical and demOgRaphic Features of Patients With Uncontrolled Severe Asthma in Russia (CORSAR)
Recruiting · NCT06472310 · Observational (researchers observe without assigning treatment) · Lead sponsor: AstraZeneca
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 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 corticosteroids (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.
- Patients with the availability of at least 52 weeks of follow-up data (prior to inclusion) in the medical records.
Exclusion criteria
- 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.
Where it is running
40 locations listed.
- Research Site - Astrakhan, Russia
- Research Site - Barnaul, Russia
- Research Site - Blagoveshchensk, Russia
- Research Site - Bryansk, Russia
- Research Site - Chelyabinsk, Russia
- Research Site - Gatchina, Russia
- Research Site - Irkutsk, Russia
- Research Site - Izhevsk, Russia
- Research Site - Kazan', Russia
- Research Site - Kemerovo, Russia
- Research Site - Khabarovsk, Russia
- Research Site - Krasnodar, Russia
- Research Site - Krasnoyarsk, Russia
- Research Site - Moscow, Russia
- Research Site - Murmansk, Russia
- Research Site - Nal'chik, Russia
- Research Site - Nizhny Novgorod, Russia
- Research Site - Nizhny Novgorod, Russia
- Research Site - Novosibirsk, Russia
- Research Site - Omsk, Russia
- Research Site - Orenburg, Russia
- Research Site - Petrozavodsk, Russia
- Research Site - Rostov-on-Don, Russia
- Research Site - Ryazan, Russia
- Research Site - Saint Petersburg, Russia
- Research Site - Saint Petersburg, Russia
- Research Site - Samara, Russia
- Research Site - Saratov, Russia
- Research Site - Smolensk, Russia
- Research Site - Stavropol, Russia
- Research Site - Tomsk, Russia
- Research Site - Ufa, Russia
- Research Site - Ulan-Ude, Russia
- Research Site - Verkhnyaya Pyshma, Russia
- Research Site - Vladimir, Russia
- Research Site - Vladivostok, Russia
- Research Site - Volgograd, Russia
- Research Site - Voronezh, Russia
- Research Site - Yakutsk, Russia
- Research Site - Yekaterinburg, Russia