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HDM and Silver Birch NAC Standardisation

NCT05378594 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-11-03

No results posted yet for this study

Summary

This study aims to establish dose-responses to nasal allergen challenge using silver birch pollen and house dust mite allergen extracts in participants with allergic rhinitis, sensitised to either or both of these allergens. The allergen extracts used will be Itulazax tablets (silver birch pollen allergen sublingual tablets, ALK-Abello, Denmark) and Acarizax tablets (house dust mite allergen sublingual tablets, ALK-Abello, Denmark). The results will allow identification of the dose of each allergen typically producing a moderate severity response, which could then be used in future, interventional and investigational studies.

A control group - healthy individuals with no allergic rhinitis - will be recruited to demonstrate the absence of an irritant/non-allergic effect of the nasal allergen challenge procedure.

Conditions

  • Allergic Rhinitis

Interventions

DIAGNOSTIC_TEST

Nasal allergen challenge

graded nasal allergen challenge to increasing concentrations of allergen with monitoring of nasal symptoms and peak nasal inspiratory flow

Sponsors & Collaborators

  • Royal Brompton & Harefield NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Guy Scadding, MD PhD · Royal Bromtpton Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-22
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05378594 on ClinicalTrials.gov