Clinical Trials Logo

Clinical Trial Summary

Allergic rhinitis/rhinoconjunctivitis is a symptomatic disorder of the nose induced by an immunoglobulin E (IgE) mediated inflammatory response. Treatment may involve pharmacotherapy and specific immunotherapy (IT). IT represents the only treatment that might alter the natural course of the disease. The amount of administered allergen is crucial for both efficacy and safety of specific IT. SUBLIVAC FIX Mite mixture is a preparation for sublingual IT (SLIT) and is indicated for the treatment of allergic disorders such as allergic rhinitis and rhinoconjunctivitis, caused by sensitisation to house dust mite (HDM) allergens.

According to the European Medicines Agency Guideline on the clinical development of products for specific IT for the treatment of allergic diseases, products should be tested at different dosages to provide preliminary data on safety and tolerability with regard to the maximum tolerated dose and suitable dose escalation scheme. This trial is designed to investigate the tolerability and safety of different dosages of SUBLIVAC FIX Mite mixture.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


NCT number NCT02345278
Study type Interventional
Source HAL Allergy
Contact
Status Completed
Phase Phase 1/Phase 2
Start date May 2015
Completion date November 2015

See also
  Status Clinical Trial Phase
Completed NCT02443805 - Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR Phase 3
Completed NCT03094845 - Safety and Clinical Tolerability of hdmASIT+TM Peptides Administered in HDM-induced Allergic Patients Phase 2
Completed NCT01930461 - Dose Ranging Study of SLIT Tablets of House Dust Mite Allergen Extracts (HDM) in Adults With HDM-associated Allergic Asthma Phase 2
Completed NCT01923792 - ToleroMune House Dust Mite Follow on Study N/A
Completed NCT00574704 - A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis Phase 2
Completed NCT00263549 - Safety and Efficacy of House Dust Mite Allergen Extract in the Treatment of Allergic Rhinoconjunctivitis Phase 4
Completed NCT05019209 - Skin Responses and T Cell Immunology After House Dust Mite Exposure in Sensitized Atopic Dermatitis Patients N/A
Recruiting NCT02238353 - AZELASTINE/FLUTICASONE (AZE/FLU) Nasal Spray on Symptom Control, Nasal Mediators and Nasal Hyperresponsiveness in Allergic Rhinitis (AR) Phase 4
Completed NCT01454544 - A One Year Trial Evaluating the Safety and Efficacy of the ALK House Dust Mite Allergy Tablet Phase 3
Terminated NCT01777464 - Role of the Central Nervous System in Allergic Rhinitis N/A
Completed NCT00574223 - A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis Phase 2
Completed NCT01608243 - Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts Phase 1
Completed NCT04435678 - Diagnostic Accuracy of the MADx Multi Array Xplorer (MAX 45k) Automated Laboratory System and the MADx Allergy Explorer Version 2 (ALEX²) - IgE Multiplex Test for the Diagnosis of Pre-defined Groups of Specific High-priority Allergens N/A
Completed NCT01134757 - Safety of Bronchial Allergen Challenge and Predictors for Positive Reaction. N/A
Recruiting NCT05395689 - Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM Phase 3
Not yet recruiting NCT05400811 - Efficacy and Safety Evaluation for the Treatment of HDM Induced Allergic Asthma and Rhinitis/Rhinoconjunctivitis Phase 3
Not yet recruiting NCT05450289 - The Efficacy of Nigella Sativa in Children With House Dust Mite-Induced Respiratory Allergy Receiving Immunotherapy N/A
Recruiting NCT05174689 - Epigenetic Regulation of Exercise Induced Asthma N/A
Terminated NCT04874714 - Efficacy and Safety Evaluation for the Treatment of Asthma and Allergic Rhinitis/Rhinoconjunctivitis Phase 3
Completed NCT00380926 - Fish Oil and Asthma in House Dust Mite Allergy Phase 2/Phase 3