NCT05378594

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 22, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

November 3, 2022

Status Verified

October 1, 2022

Enrollment Period

2 months

First QC Date

May 12, 2022

Last Update Submit

October 31, 2022

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • Total nasal symptom score, area under the curve, during nasal allergen challenge

    0-12 scale

    0-90 minutes

Secondary Outcomes (1)

  • Peak nasal inspiratory flow, area under the curve, during nasal allergen challenge

    0-90 minutes

Other Outcomes (1)

  • Modal dose of allergen provoking a total nasal symptom score of at least 7/12 for each allergen

    10 minutes

Study Arms (2)

House dust mite nasal allergen challenge

EXPERIMENTAL

House dust mite allergic patients to undergo nasal allergen challenge with house dust mite extract

Diagnostic Test: Nasal allergen challenge

Silver birch pollen nasal allergen challenge

EXPERIMENTAL

Silver birch pollen allergic patients to undergo nasal allergen challenge with silver birch pollen extract

Diagnostic Test: Nasal allergen challenge

Interventions

Nasal allergen challengeDIAGNOSTIC_TEST

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

House dust mite nasal allergen challengeSilver birch pollen nasal allergen challenge

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 to 65 years
  • A clinical history of perennial allergic rhinitis for at least 2 years with house dust mite allergen a potential cause of symptoms
  • Positive skin prick test response, defined as wheal diameter ≥ 5 mm, to house dust mite allergen extract
  • For women of childbearing age, a negative urine pregnancy test at the time of screening and willingness to use an effective form of contraception for the duration of involvement in the study.
  • The ability to give informed consent and comply with study procedures.
  • Adults aged 18 to 65 years.
  • A clinical history of seasonal allergic rhinitis in February-May for at least 2 years.
  • Positive skin prick test response, defined as wheal diameter ≥ 5 mm, to silver birch pollen allergen extract.
  • For women of childbearing age, a negative urine pregnancy test at the time of screening and willingness to use an effective form of contraception for the duration of involvement in the study.
  • The ability to give informed consent and comply with study procedures.
  • Adults aged 18 to 65 years.
  • The ability to give informed consent and comply with study procedures.

You may not qualify if:

  • History of previous allergen immunotherapy to the relevant allergen being tested in the past 10 years
  • Pre-bronchodilator FEV1 \< 70% of predicted value at screening.
  • Perennial asthma requiring regular inhaled corticosteroids.
  • History of emergency visit or hospital admission for asthma in the previous 12 months.
  • History of chronic obstructive pulmonary disease
  • History of significant recurrent acute sinusitis, defined as 2 episodes per year for the last 2 years, all of which required antibiotic treatment.
  • History of chronic sinusitis, defined as sinus symptoms lasting greater than 12 weeks that includes 2 or more major factors or 1 major factor and 2 minor factors. Major factors are defined as facial pain or pressure, nasal obstruction or blockage, nasal discharge or purulence or discolored postnasal discharge, purulence in nasal cavity, or impaired or loss of smell. Minor factors are defined as headache, fever, halitosis, fatigue, dental pain, cough, ear pain, pressure, or fullness.
  • History of life-threatening anaphylaxis or angioedema.
  • Ongoing systemic immunosuppressive treatment.
  • The use of any investigational drug within 30 days of the screening visit.
  • The presence of any medical condition that the investigator deems incompatible with participation in the study.
  • A history of hay fever, chronic rhinitis/rhinosinusitis other than symptoms experienced during viral colds or other respiratory tract infections.
  • A positive skin prick test to any of a panel of common aeroallergens including grass pollen (Timothy grass), silver birch (Betula verrucosa), house dust mite (Dermatophagoides pteronyssinus), cat hair (Felis domesticus), dog hair (Canis familiaris), and common moulds (Aspergillus fumigatus., Cladosporium sp., Alternaria sp.), with adequate positive and negative controls.
  • Pre-bronchodilator FEV1 \< 70% of predicted value at screening.
  • Perennial asthma requiring regular inhaled corticosteroids.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Guy Scadding, MD PhD

    Royal Bromtpton Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guy Scadding, MD PhD

CONTACT

07796305850g.scadding@rbht.nhs.uk

Steven Durham, MD

CONTACT

s.durham@imperial.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 20 participants with silver birch pollen allergic rhinitis, 20 with house dust mite allergic rhinitis, dual allergic participants will be able to take part in both arms of the study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2022

First Posted

May 18, 2022

Study Start

September 22, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

November 3, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)