Evidence map›Paper›PMID 38362183›Full record

ArticleLaryngoscope investigative otolaryngology2024

Inhaled fosamprenavir for laryngopharyngeal reflux: Toxicology and fluid dynamics modeling.

Alexandra Lesnick, Tina L Samuels, Donna Seabloom, Beverly Wuertz, Abhilash Ojha, Davis Seelig, Frank Ondrey, Timothy S Wiedmann, Chris Hogan, Emma Torii and 5 more

Open access · goldAbstract read
In one paragraph

Article in Laryngoscope investigative otolaryngology, 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
6.0field-weighted citation impact, top 4% of its field
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, 13 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  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

15 authors at 3 institutions in 1 country.

Alexandra LesnickOtolaryngology and Communication Sciences Medical College of Wisconsin Milwaukee Wisconsin USA.ORCID https://orcid.org/0009-0000-7052-7762
Tina L SamuelsOtolaryngology and Communication Sciences Medical College of Wisconsin Milwaukee Wisconsin USA.ORCID https://orcid.org/0000-0002-7045-357X
Donna SeabloomOtolaryngology Head and Neck Surgery University of Minnesota Minneapolis Minnesota USA.
Beverly WuertzOtolaryngology Head and Neck Surgery University of Minnesota Minneapolis Minnesota USA.
Abhilash OjhaMechanical Engineering University of Minnesota Minneapolis Minnesota USA.
Davis SeeligComparative Pathology Shared Resource Masonic Cancer Center, University of Minnesota Minneapolis Minnesota USA.
Frank OndreyOtolaryngology Head and Neck Surgery University of Minnesota Minneapolis Minnesota USA.
Timothy S WiedmannPharmaceutics University of Minnesota Minneapolis Minnesota USA.
Chris HoganMechanical Engineering University of Minnesota Minneapolis Minnesota USA.
Emma ToriiComparative Pathology Shared Resource Masonic Cancer Center, University of Minnesota Minneapolis Minnesota USA.
Hui OuyangMechanical Engineering University of Texas-Dallas Dallas Texas USA.
Ke YanPediatrics Quantitative Health Sciences Medical College of Wisconsin Milwaukee Wisconsin USA.
Guilherme J M GarciaOtolaryngology and Communication Sciences Medical College of Wisconsin Milwaukee Wisconsin USA.ORCID https://orcid.org/0000-0003-2995-9226
Jonathan M BockOtolaryngology and Communication Sciences Medical College of Wisconsin Milwaukee Wisconsin USA.ORCID https://orcid.org/0000-0002-4367-7527
Nikki JohnstonOtolaryngology and Communication Sciences Medical College of Wisconsin Milwaukee Wisconsin USA.
University of Minnesota · USMedical College of Wisconsin · USUniversity of Dallas · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objectives: Approximately 25% of Americans suffer from laryngopharyngeal reflux (LPR), a disease for which no effective medical therapy exists. Pepsin is a predominant source of damage during LPR and a key therapeutic target. Fosamprenavir (FOS) inhibits pepsin and prevents damage in an LPR mouse model. Inhaled FOS protects at a lower dose than oral; however, the safety of inhaled FOS is unknown and there are no inhalers for laryngopharyngeal delivery. A pre-Good Lab Practice (GLP) study of inhaled FOS was performed to assess safety and computational fluid dynamics (CFD) modeling used to predict the optimal particle size for a laryngopharyngeal dry powder inhaler (DPI). Methods: Aerosolized FOS, amprenavir (APR), or air (control) were provided 5 days/week for 4 weeks ( Results: No significant increase was observed in histologic lesions, cytokines, or cardiotoxicity markers in FOS or APR groups relative to the control. CFD predicted that laryngopharyngeal deposition was maximized with aerodynamic diameters of 8.1-11.5 μm for inhalation rates of 30-60 L/min. Conclusions: A 4-week pre-GLP study supports the safety of inhaled FOS. A formal GLP assessment is underway to support a phase I clinical trial of an FOS DPI for LPR. Level of Evidence: NA.

Indexed as

computational fluid dynamicsdry powder inhalerlaryngopharyngeal deliverylaryngopharyngeal refluxpepsin

Identifiers

PMID38362183
PMCPMC10866582
OpenAlexW4391173959

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.