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Aggravated Airway Inflammation: Research on Biological Treatment (Mepolizumab)

NCT04823585 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2026-03-24

Study results available
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Summary

Primary objective:

to investigate the efficacy of Mepolizumab 100 milligram (mg) every month compared to placebo in reducing validated Sinonasal Outcome Test -22 score and on reducing endoscopic Nasal Polyp Score. The participants have a triad of chronic rhinosinusitis with nasal polyps (CRSwNP), asthma and non-steroidal anti-inflammatory drug exacerbated respiratory disease (NERD). The investigators will evaluate whether mepolizumab reduces the need for increased drug dosage (topical corticosteroid or bronchodilator dosage) and improves lung and nasal function more effectively than placebo.

This first visit ensures the inclusion and exclusion criteria of the subject. If necessary, NERD will be verified by an ASA challenge test at a second additional visit. Participants have also 6 visits, on four of which subcutaneous injection of the study product is administered. During visits, a clinical examination, airway function tests, and nasal, blood, urine, and stool samples are also taken to elucidate predictive biomarkers of severely symptomatic NERD patients.

Conditions

Interventions

DRUG

Mepolizumab

Solution. Subcutaneous. Mepolizumab is a biological drug, a humanized monoclonal antibody against interleukin-5.

DRUG

Placebo

Solution. Subcutaneous.

Sponsors & Collaborators

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Sanna Toppila-Salmi, MD PhD, PI · Helsinki University Hospital, Skin and Allergy Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-12
Primary Completion
2025-01-16
Completion
2025-01-16

Countries

  • Finland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04823585 on ClinicalTrials.gov