Evidence map›Paper›PMID 40258991›Full record

Trial reportEuropean archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery2025

Adelmidrol to fight upper airways inflammation in children: a pilot case control study to safety and efficacy.

Antonio Della Volpe, Chiara Bruno, Pietro De Luca, Massimo Ralli, Arianna Di Stadio

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07675512 (Effect of Adelmidrol Nasal Spray on Chronic Rhinosinusitis With Nasal Polyps), 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.

NCT07675512 nacompletednot on this map

Effect of Adelmidrol Nasal Spray on Chronic Rhinosinusitis With Nasal Polyps: A Randomized Controlled Study Evaluating Clinical, Endoscopic, and Radiological Outcomes Before and After Functional Endoscopic Sinus Surgery (FESS)

TypeinterventionalSponsorUniversity of Campania Luigi VanvitelliRan2025 to 2026Enrolled60ConditionsChronic Sinusitis With Nasal PolypsArmsAdelmidrol spray -Rinidrol, Nasonex Nasal Spray, Nasonex Nasal Spray + Rinidrol
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. 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

5 authors.

Antonio Della VolpeOtolaryngology Department, Santobono-Posillipon Hospital, Via Mario Fiore 6, 80129, Naples, Italy.
Chiara BrunoOtolaryngology Department, Santobono-Posillipon Hospital, Via Mario Fiore 6, 80129, Naples, Italy.
Pietro De LucaDepartment of Otolaryngology, Tiberina-Isola Gemelli Hospital, Via di Ponte Quattro capi, 39, 00186, Rome, Italy.
Massimo RalliOrgan of Sense Department, University La Sapienza of Rome, Via del Policlinico 155, 00161, Rome, Italy.
Arianna Di StadioENT Department, University of Campania "Luigi Vanvitelli", Naples, Italy. arianna.distadio@unicampania.it.ORCID http://orcid.org/0000-0001-5510-3814

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeInflammations of the upper respiratory tract (URT) are common both in adults and children and they are generally treated using aerosol therapy with mucolytic medications and steroids. When these inflammations affect children, the treatment must be rapid and resolutive to prevent complications. Steroids present some contraindications, i.e. alteration of smell, that must be considered especially in children. Therefore, alternative treatments that have similar efficacy but limited adverse effects should be considered. This study aims at evaluating the efficacy of Adelmidrol to treat inflammation of the URT in children.

methodsCase-Control study. Control group used standard treatment for URT inflammation (mucolytics and steroids); treatment groups were treated by Adelmidrol spray. Sixty children (age range 2.5-4.5 years) were randomly assigned to (i) control group, (ii) treatment group 1 (TG1)- Adelmidrol nasal spray only and (iii) treatment group 2 (TG2), in which Adelmidrol was administered in both nasal and oral spray solution. The URT and the tympanic membrane were evaluated at T0, T1 (30 days) and T2 (90 days). The treatments were performed for 90 consecutive days.

resultsAt the end of the treatment, TG2 (combination of nasal and oral sprays) had the best outcomes both on URT findings (χ²: p = 0.0004) and tympanic membrane conditions (χ²: p = 0.03). TG1 showed similar outcome of CG.

conclusionsThese preliminary results in our group of 60 children showed that Adelmidrol had the same efficacy of standard treatment when used as nasal spray only and was better than the standard treatment when used combining nasal and oral sprays. The molecule seems to offer the same benefit of standard treatment without side effects. If confirmed on a larger sample, the use of Adelmidrol could be suggested as an alternative to traditional treatment for the inflammation of URT in children.

Indexed as

Case-Control StudiesChild, PreschoolFemaleHumansMaleNasal SpraysPilot ProjectsTreatment OutcomeNasal SpraysAdemidrolAdenoidsPediatricsTonsilsTympanic membraneUpper respiratory infection

Identifiers

PMID40258991
PMCPMC12122658

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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.