Evidence map›Paper›PMID 40463360›Full record

ArticleFrontiers in allergy2025

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

Sanna Toppila-Salmi, Annina Lyly, Viljami Salmi, Mikko Nuutinen, Michael Kilpiö, Tanzeela Hanif, Mikko Niemi, Anu Laulajainen-Hongisto, Lena Hafrén, Mika Mäkelä and 3 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 NCT03825757 (Aggravated Airway Inflammation), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT03825757 nacompletednot on this map

Aggravated Airway Inflammation: Research on Genomics and Optimal Medical Care (AirGOs-medical)

TypeinterventionalSponsorSanna SalmiRan2019 to 2023Enrolled40ConditionsChronic Rhinosinusitis (Diagnosis)ArmsPlacebo Oral Tablet, Acetyl Salicylic Acid
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Review
  3. Systemic N-Acylethanolamines and Other Lipid Mediators Are Associated With NSAID-Exacerbated Respiratory Disease.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2026
    Article
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

13 authors.

Sanna Toppila-SalmiDepartment of Otorhinolaryngology, University of Eastern Finland, Joensuu and Kuopio, Finland.
Annina LylyDepartment of Allergology, Inflammation Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Viljami SalmiDepartment of Otorhinolaryngology, University of Eastern Finland, Joensuu and Kuopio, Finland.
Mikko NuutinenDepartment of Otorhinolaryngology, University of Eastern Finland, Joensuu and Kuopio, Finland.
Michael KilpiöDepartment of Otorhinolaryngology, University of Eastern Finland, Joensuu and Kuopio, Finland.
Tanzeela HanifDepartment of Otorhinolaryngology, University of Eastern Finland, Joensuu and Kuopio, Finland.
Mikko NiemiDepartment of Clinical Pharmacology, Faculty of Medicine, University of Helsinki, Helsinki, Finland.
Anu Laulajainen-HongistoDepartment of Otorhinolaryngology-Head and Neck Surgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Lena HafrénDepartment 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 KauppiDepartment of Pulmonary Diseases and Allergology, Heart and Lung Center, 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.
Alma HeleväDepartment 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 a chronic inflammatory condition affecting the nasal passages and paranasal sinuses. It is characterized by persistent inflammation and often leads to a considerable decline in health-related quality of life (HRQoL). A subset of these patients-approximately 17.7%-have NSAID-exacerbated respiratory disease (N-ERD), a more severe form that frequently necessitates repeated sinus surgeries and rescue therapies. Compared with individuals without N-ERD, affected patients are more prone to asthma flare-ups, severe hypersensitivity reactions, and loss of smell. Treatment with acetylsalicylic acid (ASA) following desensitization (ATAD) has been suggested as a therapeutic option in cases of severe CRSwNP with N-ERD. While this approach may offer symptom improvement, decreased polyp burden, and enhanced QoL, it is not without risks, such as gastrointestinal irritation and bleeding complications. This randomized, double-blind, placebo-controlled clinical trial (RDBCT) assesses the effectiveness and safety of ATAD in comparison with placebo in patients suffering from severe CRSwNP, N-ERD, and asthma. The study explores various outcomes, including reduction in polyp burden, improvement in QoL, treatment-related side effects, and biomarker analyses derived from nasal swabs, blood, and urine samples. Methods: AirGOs Medical is an investigator-initiated RDBCT conducted at Helsinki University Hospital. Participants are randomized to receive either ATAD or placebo. The primary endpoint is the change in the SNOT-22 score observed at the 11-month follow-up. Secondary measures include variations in nasal polyp scores, CRS symptom control, general HRQoL, work productivity loss, peak nasal inspiratory flow (PNIF) with or without acoustic rhinometry (ARM), olfactory function assessed by the Sniffin' Sticks identification test, spirometry, peak expiratory flow (PEF), and histopathological findings at the 12-month follow-up. Discussion: The AirGOs Medical trial is expected to generate data on the therapeutic value and safety profile of ATAD in patients with coexisting severe CRSwNP, N-ERD, and asthma, potentially informing future clinical practice. Trial registration: [ClinicalTrials.gov], identifier [NCT03825757]. Registered on 28.2.2019.

Indexed as

acetylsalicylic acidaspirinchronic rhinosinusitisnasal polypNSAID-exacerbated respiratory disease (N-ERD)QoLsinusitis

Identifiers

PMID40463360
PMCPMC12129994

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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.