Asthma Drug's hidden effects revealed in small study

NCT ID NCT05063981

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at how mepolizumab, a biologic drug, changes inflammation in people with severe eosinophilic asthma. Researchers measured immune and metabolic markers in the nose, lungs, and blood of 15 adults. The goal was to better understand the drug's full impact beyond just reducing asthma attacks.

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

15 people

The number who actually took part.

Started

Nov 2021

Finished

Sep 2025

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

We will enroll patients with severe refractory eosinophilic asthma for whom treatment with mepolizumab is indicated, according to the AIFA recommendations.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Eligibility for mepolizumab treatment according to clinical practice; * age between 18 and 75 years; * diagnosis of severe eosinophilic refractory asthma, defined as peripheral blood eosinophil count (BEC) \> 300 cells/μL and at least two documented exacerbations within the previous 12 months; * ongoing treatment with high daily doses of inhaled corticosteroids (ICS) combined with long-acting β2-agonists (LABA), plus at least one additional controller medication for a minimum of 12 months. Exclusion criteria: * current smoking; * diagnosis of other chronic pulmonary diseases; * coexisting chronic rhinosinusitis with nasal polyps; * use of systemic corticosteroids at any dose within the 6 weeks prior to enrollment; * use of immunosuppressive therapies; * receipt of live attenuated vaccines within 30 days prior to enrollment; * current or recent history (within the last 5 years) of malignancy, except in cases of complete remission; * diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA); * upper or lower respiratory tract infections within 30 days prior to signing informed consent or during the screening/run-in period; * any clinically significant abnormalities identified during screening through physical examination, vital signs assessment, hematology, or clinical chemistry, which, in the opinion of the investigator, could pose a risk to patient safety or interfere with study outcomes or compliance. * known immunodeficiency (primary or secondary); * pregnancy; * concurrent treatment with other biologics for asthma or other conditions (except for stable allergen immunotherapy, defined as an unchanged dose and regimen at screening); prior biologic therapy for asthma within 6 months before starting mepolizumab; planned surgical procedures during the study period; * participation in another interventional or post-authorization safety study.

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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.

Contacts and locations

Locations

  • Istituti Clinici Scientifici Maugeri IRCCS

    Telese Terme, BN, 82037, Italy

  • Istituti Clinici Scientifici Maugeri IRCCS

    Tradate, Varese, Italy

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