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Massive asthma registry aims to unlock secrets of severe disease

NCT ID NCT06625216

Knowledge-focused Sponsor: Società Italiana di Allergologia, Asma e Immunologia Clinica Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is a registry that will collect information from 5,000 people with severe asthma over time. The goal is to better understand the disease, how well patients follow their treatment plans, and how different biologic medications work in everyday life. Participants must be over 12 years old and have a confirmed diagnosis of severe asthma.

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

Feb 2017

Expected to finish

Feb 2037

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Patients older than 12 years, diagnosed for severe asthma by a specialist, according to the ERS/ATS criteria, attending respiratory or allergy clinic for a scheduled visit are eligible for study enrollment. If inclusion/exclusion criteria are satisfied, a written consent to participate in the study will be obtained and an informative leaflet for the patient and his/her GPs will be delivered.

Ages

13 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. signed informed consent and privacy disclaimer; 2. age \> 12 years; 3. diagnosis of severe asthma according to the ERS/ATS criteria: 1. During treatment with: * High-dose ICS + at least one addistional controller (LABA, montelukast, or theophylline) or * Oral corticosteroids \>6 months/year 2. at least one of the following occurs or would occur if treatment would be reduced: * ACT \<20 or ACQ\>1.5 * At least 2 exacerbations in the last 12 months * At least 1 exacerbation treated in hospital or requiring mechanical ventilation in the last 12 months * FEV1 \<80% (if FEV1/FVC below the lower limit of normal) Exclusion Criteria have not been considered in order to have a realistic view of severe asthma in real life.

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Conditions

The condition(s) this trial relates to.

asthma chronic asthma

As listed by the trial registrant

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

Severe asthma

How to take part

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

  1. The places running it

    1 site. 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

  • Personalized Medicine, Asthma and Allergy - IRCCS Humanitas Research Hospital, Rozzano, Italy

    RECRUITING

    Rozzano, Milano, 20089, Italy

More trials for these conditions

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