NCT02345278

SUBLIVAC FIX Mite Mixture Dose Tolerability Study

A Randomized, Double-blind, Placebo-controlled Study to Determine Tolerability and Safety of Different Dosages of SUBLIVAC FIX Mite Mixture in Patients With Allergic Rhinitis / Rhinoconjunctivitis Caused by House Dust Mites

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: HAL Allergy · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• House Dust Mite Allergy

Interventions

Type	Name	Description
DRUG	SUBLIVAC FIX Mite mixture	Study medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month.
OTHER	Placebo	Study medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month.

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2015-01-26
• Last updated: 2015-12-02

Locations

10 sites across 1 country: Germany