Evidence map›Paper›PMID 40191526›Full record

ArticleFrontiers in allergy2025

Study protocol for a randomized double-blinded placebo-controlled trial on mepolizumab for patients with chronic rhinosinusitis with nasal polyps, NSAID exacerbated respiratory disease and asthma.

Annina Lyly, Johanna Sahlman, Karoliina Pajala, Maija Salminen, Saara Sillanpää, Jura Numminen, Tanzeela Hanif, Anu Laulajainen-Hongisto, Mika Mäkelä, Paula Kauppi and 5 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Frontiers in allergy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04823585 (Aggravated Airway Inflammation), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04823585 phase4completednot on this map

Aggravated Airway Inflammation: Research on Biological Treatment (Mepolizumab)

TypeinterventionalSponsorHelsinki University Central HospitalRan2021 to 2025Enrolled95ConditionsAsthma, Aspirin-Induced, Chronic Rhinosinusitis With Nasal PolypsArmsMepolizumab, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Annina LylyDepartment of Allergology, Inflammation Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Johanna SahlmanDepartment of Otorhinolaryngology, University of Eastern Finland, Joensuu, Kuopio, Finland.
Karoliina PajalaDepartment of Otorhinolaryngology, University of Eastern Finland, Joensuu, Kuopio, Finland.
Maija SalminenDepartment of Otorhinolaryngology, Head and Neck Surgery, Tampere University Hospital, Tampere, Finland.
Saara SillanpääDepartment of Otorhinolaryngology, Head and Neck Surgery, Tampere University Hospital, Tampere, Finland.
Jura NumminenDepartment of Otorhinolaryngology, Head and Neck Surgery, Tampere University Hospital, Tampere, Finland.
Tanzeela HanifDepartment of Allergology, Inflammation Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Anu Laulajainen-HongistoDepartment of Otorhinolaryngology-Head and Neck Surgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Mika MäkeläDepartment of Allergology, Inflammation Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Paula KauppiHeart and Lung Center, Department of Pulmonary Diseases and Allergology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Iiris KangasniemiDepartment of Otorhinolaryngology, University of Eastern Finland, Joensuu, Kuopio, Finland.
Markus LiljaDepartment of Allergology, Inflammation Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Sari Hammaren-MalmiDepartment of Otorhinolaryngology-Head and Neck Surgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Paula VirkkulaDepartment of Otorhinolaryngology-Head and Neck Surgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Sanna Toppila-SalmiDepartment of Allergology, Inflammation Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) is an inflammatory disease of the nose and paranasal sinuses that significantly impactshealth-related quality of life. Nonsteroidal anti-inflammatory drug (NSAID) -exacerbated respiratory disease (N-ERD) affects approximately one fifth of CRSwNP patients. N-ERD and asthma increase the risk of uncontrolled CRSwNP as measured by frequent sinus surgeries and rescue treatment. Compared to non-N-ERD patients, those with N-ERD also have higher risk of asthma exacerbations, severe allergic reactions, and anosmia. Mepolizumab is a humanized monoclonal anti-IL-5 antibody shown to be effective in treating severe eosinophilic asthma and CRSwNP. While evidence suggests that mepolizumab alleviates respiratory symptoms in N-ERD patients, placebo-controlled studies remain limited. Methods: The aim of this prospective randomized, placebo-controlled, multicenter study is to investigate whether mepolizumab reduces polyp size, symptom scores, and exacerbations more than placebo during the 16-week treatment period in patients with uncontrolled CRSwNP, N-ERD and asthma. Additionally, we will examine the effect of mepolizumab on drug dosage and lung and nasal function and evaluate predictive biomarkers.We will recruit 120 patients with N-ERD, nasal polyposis and asthma in three centers in Finland. Patients will be randomized into two 16-week treatment groups in 1:1 ratio (placebo or mepolizumab 100 mg every 4 weeks). The study lasts for 6 months, including recruitment visit 2-4 weeks before randomization. Participants will attend 6 visits, during four of which they will receive a subcutaneous injection of the study product. At each visit, patient-reported outcome tests, clinical examination, airway function tests, and nasal, blood, urine, and stool samples will be conducted. Discussion: The efficacy of the 16-week anti-IL-5-treatment in this severe patient group will be analyzed, as well as possible predictive biomarkers. Clinical Trial registration: ClinicalTrials.gov ID NCT04823585. Registered on 28.3.2021.

Indexed as

asthmabiologicsCRSwNPmepolizumabNERD

Identifiers

PMID40191526
PMCPMC11968741

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.