Clinical Trials Logo

Clinical Trial Summary

To evaluate the tolerability of the vestibular administration route of birch pollen, grass pollen, ragweed pollen, and house dust mite (HDM) AIT tablets compared with the sublingual route in adult subjects with allergic rhinitis/conjunctivitis (AR/C)

Clinical Trial Description

This is a single-center randomised controlled pilot trial conducted in Canada. Subjects will be randomised (1:1) to receive vestibular or sublingual birch pollen, grass pollen, ragweed pollen, or HDM AIT in tablet form for 28±4 days, followed by 28±4 days of sublingual administration only. The ratio will be ~ 1:1:1:1 for tree-, grass-, ragweed-pollen and HDM AIT tablet treatments, with a minimum of 30 patients in each allergen group for a total of approximately 200 randomised subjects. Adults (18-65 years of age) who demonstrate birch, grass, ragweed, or HDM allergen skin prick test (SPT) positivity and with a history of birch pollen-, grass pollen-, ragweed pollen-, or HDM allergen-induced AR/C, with or without asthma are eligible for the trial. Data for the primary endpoint of severity of treatment-related AEs will be collected during the first 28±4 days of treatment. The trial consists of 3 trial periods: a screening period (up to 12 weeks), a randomised two-arm treatment period of 28±4 days, and a single-arm sublingual treatment follow-up period of 28±4 days. Screening period: Subjects will be evaluated based on eligibility criteria at visit 1 (V1). Treatment period: the randomisation visit will be performed (V2) and eligible subjects randomised in a 1:1 ratio to vestibular or sublingual AIT tablet with the appropriate allergen for their allergen sensitization. At day 28±4, a visit will be conducted (V3) for all subjects previously receiving vestibular AIT to be switched to sublingual AIT with the appropriate allergen for their allergen sensitization. Subjects previously receiving sublingual AIT will remain on their previous treatment. All subjects will discontinue treatment after 56±8 days on treatment (V4). Subjects who would like to continue the sublingual immunotherapy tablets will be permitted to do so based on physician judgment and own expense but will no longer be part of the study. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05119751
Study type Interventional
Source Clinique Spécialisée en Allergies de la Capitale
Contact Marie-Claude Joly, RN
Phone 418-659-7741
Email [email protected]
Status Recruiting
Phase Phase 4
Start date October 25, 2021
Completion date March 2022

See also
  Status Clinical Trial Phase
Completed NCT04531540 - Study to Determine Skin Irritation and/or Sensitization Potential of an Antifungal Cream Containing Trolamine (Repeated Insult Patch Test) Phase 3
Completed NCT00988065 - Sugammadex Hypersensitivity Study (Study P06042) Phase 1
Completed NCT03563066 - Effect of Benralizumab in Atopic Dermatitis Phase 2
Completed NCT02588326 - Sensitivity of Pharmacokinetics to Differences in Particle Size Distribution of Suspension-based Nasal Sprays Phase 1
Completed NCT02916888 - A Study Comparing the Quality of Life of Patients in the Treatment of Eczema by Pediatric Generalists and Specialists N/A
Completed NCT02360072 - Airway Inflammation and Bronchial Hyperresponsiveness in Rhinitic Children With or Without Asthma
Completed NCT02352168 - Airway Inflammation in Children With Allergic Rhinitis and Intervention N/A
Completed NCT01904604 - Peanut Epicutaneous Phase II Immunotherapy Clinical Trial Phase 2
Completed NCT01494649 - Pilot Study to Investigate the Efficacy of a Toothpaste in Providing Relief From Dentinal Hypersensitivity N/A
Enrolling by invitation NCT05039229 - Measures for Bioaerosol Reduction in the Salmon Industry N/A
Recruiting NCT04006106 - Defining ENDOtypes in Perioperative Hypersensitivity by Extensive Cellular and Molecular PHENotyping (ENDOPHEN)
Completed NCT04605471 - A Study to Learn More About the Safety of Ultravist in Children and in the Elderly
Completed NCT03720470 - Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy Phase 3
Not yet recruiting NCT04485299 - Clinical Assessment of Bifluorid 10 vs Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient Phase 2/Phase 3
Completed NCT02686827 - DBPC-Dose-finding-trial of Vitamin D3 for SCIT in Birch Pollen Allergic Patients. Phase 2
Completed NCT00850668 - Peanut Allergy Vaccine Study in Healthy and Peanut-allergic Adults Phase 1
Completed NCT00344344 - A Pilot Study to Evaluate the Efficacy of Refined Methods to Mitigate Indoor Allergens in North Carolina and Boston, Massachusetts Homes N/A
Not yet recruiting NCT05126407 - A Study of Olynth Saline/Ectomed Nasal Drops/Spray Based Upon Previous Usage
Completed NCT02474836 - Determination of Biological Activity of Three Allergen Extracts Phase 2
Completed NCT01731249 - Efficacy and Safety Study of a Sublingual Immunotherapy Solution to Treat Patients Suffering From Birch Pollen Allergic Rhinoconjunctivitis Phase 3