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New study digs into how mepolizumab changes nose bacteria and genes in asthma patients

NCT ID NCT06069310

Knowledge-focused Sponsor: National and Kapodistrian University of Athens Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tracks 40 people with nasal polyps and severe asthma who are taking mepolizumab, a drug that reduces inflammation. Researchers collect nose, blood, and sputum samples before treatment and at 3, 6, and 12 months to see how the drug affects symptoms, nose bacteria, and gene activity. The goal is to find patterns that predict who responds best to treatment.

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

40 people

The number who actually took part.

Started

Sep 2023

Expected to finish

Mar 2027

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

We estimate to recruit 40 CRSwNP patients (20 with and 20 without severe asthma) and 20 healthy control subjects. All participants will be adults (18 years and older) of both sexes. Clinical evaluation of CRSwNP and asthma will be made according to the European Position Paper on Rhinosinusitis and Nasal Polyps. Patients with significant sino-nasal disease and/or those who fail medical management will be evaluated for functional endoscopic sinus surgery.

Ages

18 years and older

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: * Eligible for inclusion will be patients diagnosed with CRSwNP according to the European Position Paper on Rhinosinusitis and Nasal Polyps that fulfill the criteria for initiating treatment with biologics as standard of care \[49\], suffering or not from comorbid severe asthma (CRSwNP + AS, CRSwNP - AS, respectively) who will consent to participate in the study. The study will not influence prescribing of mepolizumab to patients. Eligible to treatment women in childbearing potential will be informed before consent that they must take care of contraception and potential pregnancy during therapy as there is not enough data regarding the use of mepolizumab during pregnancy. All patients with severe asthma will be qualified for treatment with mepolizumab in accordance with GINA guidelines. Exclusion Criteria: * Patients less than 18 years of age, subjects suffering from COPD, known or suspected immunodeficiency or autoimmune disease, chronic interstitial lung diseases, cystic fibrosis, individuals exposed to systemic corticosteroid/immunosuppressive treatments, biologics for asthma care or antibiotics within the previous 3 months before mepolizumab administration, active smokers and obese individuals will be excluded from this study. Pregnant women will not be included into the study because of the potential changes that their microbiome and other host parameters could undergo during pregnancy. The control group will comprise healthy volunteers who will be free from CRS, asthma, and atopy.

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Conditions

The condition(s) this trial relates to.

chronic rhinosinusitis nasal cavity polyp pulmonary eosinophilia T2-high asthma

As listed by the trial registrant

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

Chronic rhinosinusitis with nasal polyps Chronic rhinosinusitis without nasal polyps Severe eosinophilic asthma

Contacts and locations

Locations

  • Pulmonary Dept First ICU Evangelismos Hospital

    Athens, 10676, Greece

  • Pulmonary Dept First ICU, Evagelismos Hospital

    Athens, Attica, 10676, Greece

More trials for these conditions

Other studies related to the condition(s) this trial covers.