Asthma Drug's hidden effects revealed in small study
NCT ID NCT05063981
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Asthma are added.
By submitting, you agree to our Terms of use
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a single triple inhaler tame asthma in the real world?
- Can a Three-Drug inhaler outperform the standard Two-Drug treatment for asthma?
- Can a new inhaler match Symbicort's performance?
- Fine-Mist inhalers aim to reach deep lungs in COPD
- Can a hormone supplement tame asthma?
- A wearable stethoscope may let kids with asthma monitor their lungs at home