Clinical& Demographic Profiles of patIents With unControllEd Asthma in Russia: Multi-center oBsErvational ReGistry Study
Recruiting · NCT06521229 · Observational (researchers observe without assigning treatment) · Lead sponsor: AstraZeneca
View the official record on ClinicalTrials.gov →What this trial is about
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).
Who can take part
Age range
No age limits stated
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 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.
Exclusion criteria
- 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.
Where it is running
47 locations listed.
- Research Site - Astrakhan, Russia
- Research Site - Blagoveshchensk, Russia
- Research Site - Bryansk, Russia
- Research Site - Chelyabinsk, Russia
- Research Site - Gatchina, Russia
- Research Site - Irkutsk, Russia
- Research Site - Ivanovo, Russia
- Research Site - Izhevsk, Russia
- Research Site - Kazan', Russia
- Research Site - Kemerovo, Russia
- Research Site - Krasnodar, Russia
- Research Site - Krasnoyarsk, Russia
- Research Site - Lipetsk, Russia
- Research Site - Makhachkala, Russia
- Research Site - Moscow, Russia
- Research Site - Murmansk, Russia
- Research Site - Nal'chik, Russia
- Research Site - Nizhny Novgorod, Russia
- Research Site - Nizhny Tagil, Russia
- Research Site - Novokuznetsk, Russia
- Research Site - Novosibirsk, Russia
- Research Site - Omsk, Russia
- Research Site - Omsk, Russia
- Research Site - Orenburg, Russia
- Research Site - Perm, Russia
- Research Site - Petrozavodsk, Russia
- Research Site - Pyatigorsk, 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 - Surgut, Russia
- Research Site - Tomsk, Russia
- Research Site - Tula, 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 - Voronezh, Russia
- Research Site - Yaroslavl, Russia
- Research Site - Yekaterinburg, Russia
- Research Site - Yuzhno-Sakhalinsk, Russia