Allergic Rhinitis Clinical Trial
Official title:
Prospective, Randomised, DBPC Clinical Trial to Evaluate the Efficacy and Safety of Polymerized and Mannan Conjugated Allergen Extract of Dermatophagoides for the Treatment of Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma
Prospective, randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of polymerized and mannan conjugated allergen extract of Dermatophagoides for the treatment of allergic rhinitis/rhinoconjunctivitis with or without asthma. The main objective of the clinical trial is to evaluate the clinical efficacy of the investigational medicinal product, administered sublingually, compared to placebo for the treatment of moderate-severe rhinitis/rhinoconjunctivitis with or without mild to moderate asthma and controlled using the Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (R-CSMS).
Allergen-specific immunotherapy (AIT) has been shown to be effective in relieving symptoms, reducing medication use, and improving quality of life in patients with respiratory allergies). This is thought to be due to the induction of a state of tolerance to specific allergens with long-lasting effects after discontinuation of treatment. And it is accepted that immunotherapy is the only available method for allergists to improve or cure, partially or definitely, an allergic process The study population of this clinical trial will comprise subjects allergic to mites (Dermatophagoides pteronyssinus and/or D. farinae) with symptoms of moderate-severe rhinitis/rhinoconjunctivitis with or without mild to severe controlled asthma, suitable to allergen immunotherapy. The primary efficacy endpoint will be the combined rhinitis/rhinoconjunctivitis symptom and medication score. Every single day from the beginning of the administration of the investigational drug (V2-VF), the subject will be asked to score and register his/her symptoms and record medication consumption in an electronic diary following the instructions of the application. This diary will provide the symptom score and medication consumption for each subject during the trial. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05080322 -
Efficacy and Safety of On-demand and Continuous Administration of Nasal Spray in the Treatment of Allergic Rhinitis
|
Phase 4 | |
Recruiting |
NCT06028490 -
A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis.
|
Phase 2 | |
Completed |
NCT04388358 -
Traditional Chinese Medicine for the Treatment of Perennial Allergic Rhinitis on Gut Microbiota and Immune-modulation
|
N/A | |
Recruiting |
NCT04202263 -
Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline
|
Phase 2 | |
Completed |
NCT04078009 -
Standardising Nasal Allergen Challenge in Adult With Hay Fever
|
N/A | |
Completed |
NCT03644680 -
Changes in Adaptive Immune Responses and Effector Cell Responses Upon Nasal Allergen Exposure - a Pilot Study
|
N/A | |
Completed |
NCT04541004 -
Adolescent Mite Allergy Safety Evaluation
|
Phase 3 | |
Recruiting |
NCT05378594 -
HDM and Silver Birch NAC Standardisation
|
N/A | |
Not yet recruiting |
NCT05684380 -
Efficacy and Safety of MAZ-101 in the Treatment of Persistent Allergic Rhinitis (PER)
|
Phase 3 | |
Not yet recruiting |
NCT01014325 -
Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy
|
Phase 3 | |
Completed |
NCT02943720 -
ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen
|
Phase 2 | |
Completed |
NCT02910401 -
Clinical Response to Rhinovirus Challenge
|
Phase 2 | |
Completed |
NCT02556801 -
Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy
|
Phase 2 | |
Not yet recruiting |
NCT02233426 -
Effect of Hypertonic Solutions on Allergic Rhinitis Patients
|
N/A | |
Completed |
NCT02352168 -
Airway Inflammation in Children With Allergic Rhinitis and Intervention
|
N/A | |
Completed |
NCT01918956 -
PURETHAL Birch RUSH Study
|
Phase 4 | |
Completed |
NCT01946035 -
Alpha-Blockers in Allergic Rhinitis (MAN 01)
|
Phase 4 | |
Completed |
NCT01682070 -
SUBLIVAC FIX Phleum Pratense DT/DRF
|
Phase 2 | |
Recruiting |
NCT01454492 -
The Relationship Between Allergic Rhinitis and Geographic Tongue
|
N/A | |
Completed |
NCT01438463 -
PURETHAL® Mites Dose Range Finding Study in Patients With Persistent Allergic Rhinitis/Rhinoconjunctivitis
|
Phase 2 |