Evidence map›Paper›PMID 37488728›Full record

ArticleClinical and translational allergy2023

Barrier-forming, drug-free nasal spray reduces allergic symptoms induced by house dust mite allergen.

Patricia Couroux, Nicole Grosse, Anne Marie Salapatek, Yasmeen Goyal, Oliver Pfaar, Ilja P Hohenfeld

Open access · goldAbstract read
In one paragraph

Article in Clinical and translational allergy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.2field-weighted citation impact, top 21% 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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Review
  3. 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

6 authors at 3 institutions in 3 countries.

Patricia CourouxInflamax Research DBA Cliantha Research, Mississauga, Ontario, Canada.
Nicole GrosseAltamira Medica AG, Zug, Switzerland.
Anne Marie SalapatekInflamax Research DBA Cliantha Research, Mississauga, Ontario, Canada.
Yasmeen GoyalInflamax Research DBA Cliantha Research, Mississauga, Ontario, Canada.
Oliver PfaarDepartment of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany.ORCID https://orcid.org/0000-0003-4374-9639
Ilja P HohenfeldAltamira Medica AG, Zug, Switzerland.ORCID https://orcid.org/0000-0002-5592-8223
Inflamax Research (Canada) · CAAltamira Technologies · USPhilipps University of Marburg · DE

Funding

Altamira Medica AG
6 · The paper itself

Abstract

backgroundHouse Dust Mite (HDM) is the most common indoor allergen triggering allergic symptoms. First-line pharmacotherapy treatment is recommended in international guidelines, while the avoidance of allergens represents a still unmet guideline principle. AM-301 is a new non-pharmacological nasal spray that creates a protective gel-like barrier on the nasal mucosa, preventing the contact with the allergens.

methodsThis randomized, open-label, 3-period crossover study assessed the efficacy and safety of AM-301. The objective was to determine whether AM-301 reduces allergic rhinitis (AR) symptoms in patients exposed to HDM allergens. Adults with confirmed Perennial Allergic Rhinitis (PAR; n = 37) were exposed to HDM allergen in a controlled Allergen Exposure Chamber before and during a treatment course of AM-301 (in six different sequences) within 3 weeks (A: One spray AM-301 per nostril/B: Two sprays AM-301 per nostril/C: no treatment). For the primary efficacy analysis, data from the total nasal symptom score (TNSS) were pooled from treatment A + B (D) and analyzed with Analysis of Covariance Model. As secondary endpoints, single time points, visits and symptoms were analyzed.

resultsThe primary endpoint (overall change in TNSS from baseline over all three visits) showed significant results (p = 0.0085). A comparable alleviation of all four symptoms (itchy nose, nasal congestion, runny nose, sneezing) by the protective layer started to emerge after 40 min and lasted up to 180 min (end of challenge). AM-301 resulted to be safe and well-tolerated.

conclusionAM-301 significantly reduced HDM-related allergic symptoms in a standardized allergen challenge. Protection was observed to last up to 180 min.

Indexed as

allergen exposure chamber (AEC)allergic rhinitis (AR)house dust mite (HDM)nasal spraythixotropic formulation

Identifiers

PMID37488728
PMCPMC10345461
OpenAlexW4384343558

What OpenQuestion 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 OpenQuestion graph.