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Massive russian study to map severe asthma treatment gaps

NCT ID NCT06472310

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study is observing 5,000 adults in Russia with severe, uncontrolled asthma who are not taking biologic medications. Researchers will collect information on their current treatments, health history, and lifestyle factors. The goal is to better understand how these patients are managed in routine care across different regions of Russia.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 5,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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. 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 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    36 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Astrakhan, Russia

  • Research Site

    RECRUITING

    Barnaul, Russia

  • Research Site

    RECRUITING

    Blagoveshchensk, Russia

  • Research Site

    RECRUITING

    Bryansk, Russia

  • Research Site

    RECRUITING

    Chelyabinsk, Russia

  • Research Site

    RECRUITING

    Gatchina, Russia

  • Research Site

    RECRUITING

    Irkutsk, Russia

  • Research Site

    RECRUITING

    Izhevsk, Russia

  • Research Site

    RECRUITING

    Kazan', Russia

  • Research Site

    RECRUITING

    Kemerovo, Russia

  • Research Site

    RECRUITING

    Khabarovsk, Russia

  • Research Site

    COMPLETED

    Krasnodar, Russia

  • Research Site

    RECRUITING

    Krasnoyarsk, Russia

  • Research Site

    RECRUITING

    Moscow, Russia

  • Research Site

    RECRUITING

    Murmansk, Russia

  • Research Site

    RECRUITING

    Nal'chik, Russia

  • Research Site

    RECRUITING

    Nizhny Novgorod, Russia

  • Research Site

    COMPLETED

    Nizhny Novgorod, Russia

  • Research Site

    RECRUITING

    Novosibirsk, Russia

  • Research Site

    RECRUITING

    Omsk, Russia

  • Research Site

    RECRUITING

    Orenburg, Russia

  • Research Site

    RECRUITING

    Petrozavodsk, Russia

  • Research Site

    RECRUITING

    Rostov-on-Don, Russia

  • Research Site

    RECRUITING

    Ryazan, Russia

  • Research Site

    RECRUITING

    Saint Petersburg, Russia

  • Research Site

    COMPLETED

    Saint Petersburg, Russia

  • Research Site

    RECRUITING

    Samara, Russia

  • Research Site

    RECRUITING

    Saratov, Russia

  • Research Site

    COMPLETED

    Smolensk, Russia

  • Research Site

    RECRUITING

    Stavropol, Russia

  • Research Site

    RECRUITING

    Tomsk, Russia

  • Research Site

    RECRUITING

    Ufa, Russia

  • Research Site

    RECRUITING

    Ulan-Ude, Russia

  • Research Site

    RECRUITING

    Verkhnyaya Pyshma, Russia

  • Research Site

    RECRUITING

    Vladimir, Russia

  • Research Site

    RECRUITING

    Vladivostok, Russia

  • Research Site

    RECRUITING

    Volgograd, Russia

  • Research Site

    RECRUITING

    Voronezh, Russia

  • Research Site

    RECRUITING

    Yakutsk, Russia

  • Research Site

    RECRUITING

    Yekaterinburg, Russia

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