Evidence map›Paper›PMID 39065569›Full record

ArticlePharmaceutics2024

Pharmacokinetic Evaluation of Oral Viscous Budesonide in Paediatric Patients with Eosinophilic Oesophagitis in Repaired Oesophageal Atresia.

Raffaele Simeoli, Sebastiano A G Lava, Alessandro Di Deo, Marco Roversi, Sara Cairoli, Renato Tambucci, Francesca Rea, Monica Malamisura, Giulia Angelino, Isabella Biondi and 7 more

Abstract read
In one paragraph

Article in Pharmaceutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. 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

17 authors.

Raffaele SimeoliDivision of Metabolic Diseases, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.ORCID 0000-0002-3989-7703
Sebastiano A G LavaClinical Pharmacology & Therapeutics Group, University College London, London WC1N 3JH, UK.ORCID 0000-0002-8391-5462
Alessandro Di DeoClinical Pharmacology & Therapeutics Group, University College London, London WC1N 3JH, UK.
Marco RoversiPhD Program in Immunology, Molecular Medicine and Applied Biotechnology, University of Rome Tor Vergata, 00133 Rome, Italy.ORCID 0000-0003-0858-033X
Sara CairoliDivision of Metabolic Diseases, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.ORCID 0000-0002-5925-0974
Renato TambucciDigestive Endoscopy Unit, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.
Francesca ReaDigestive Endoscopy Unit, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.
Monica MalamisuraDigestive Endoscopy Unit, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.
Giulia AngelinoDigestive Endoscopy Unit, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.ORCID 0000-0001-8719-9670
Isabella BiondiCentre of Excellence for the Development and Implementation of Medicines, Vaccines, and Medical Devices for Pediatric Use, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.
Alessandra SimonettiCentre of Excellence for the Development and Implementation of Medicines, Vaccines, and Medical Devices for Pediatric Use, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.
Paola De AngelisDigestive Endoscopy Unit, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.
Carlo Dionisi ViciDivision of Metabolic Diseases, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.ORCID 0000-0002-0007-3379
Paolo RossiCentre of Excellence for the Development and Implementation of Medicines, Vaccines, and Medical Devices for Pediatric Use, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.ORCID 0000-0003-2620-7918
Giuseppe PontrelliCentre of Excellence for the Development and Implementation of Medicines, Vaccines, and Medical Devices for Pediatric Use, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.
Oscar Della PasquaClinical Pharmacology & Therapeutics Group, University College London, London WC1N 3JH, UK.ORCID 0000-0002-6211-1430
Bianca Maria GoffredoDivision of Metabolic Diseases, Bambino Gesù Children's Hospital, IRCCS, 00165 Rome, Italy.

Funding

Italian Ministry of Health with "Current Research funds." RC2019.1.6_ROSSI
6 · The paper itself

Abstract

Eosinophilic oesophagitis is a long-term complication of oesophageal atresia (EA), an uncommon condition that affects approximately 1 in 3500 infants. An exploratory, open-label phase 2 clinical trial was conducted in paediatric eosinophilic oesophagitis after oesophageal atresia (EoE-EA) to assess the safety, pharmacokinetics, and efficacy of oral viscous budesonide (OVB). In total, eight patients were enrolled in the study and assigned to a twice-daily dosing regimen of either 0.8 or 1 mg OVB, depending on age and height, administered for 12 weeks. OVB was safe and effective in the treatment of EoE-EA. The current investigation focuses on the pharmacokinetics of budesonide and the impact of an oral viscous formulation on its absorption and bioavailability. Using a non-linear mixed effects approach, two distinct absorption profiles were identified, despite marked interindividual variability in drug concentrations. Budesonide exposure was higher than previously reported in children following oral inhalation. Even though no significant effect has been observed on serum cortisol levels, future studies should consider exploring different doses, schedules, and/or treatment durations, as there may be an opportunity to reduce the risk of cortisol suppression.

Indexed as

eosinophilic oesophagitis (EoE)LC-MS/MSoesophageal atresia (EA)oral viscous budesonidepharmacokineticspopulation pharmacokinetic modellingsystemic absorption

Identifiers

PMID39065569
PMCPMC11280286

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

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 Socratic graph.