Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy

Roxall Medizin0 sites130 target enrollmentSeptember 2016

ConditionsAllergic Rhinitis

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Allergic Rhinitis
Sponsor: Roxall Medizin
Enrollment: 130
Primary Endpoint: Symptom and medication score
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The objective of this clinical trial is to assess the safety and efficacy of sublingual application of allergen extracts for specific immunotherapy in patients suffering from perennial allergic rhinitis due to house dust mites.

Registry

clinicaltrials.gov

Start Date

September 2016

End Date

September 2017

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Roxall Medizin

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Positive history of perennial allergic rhinitis
•Positive screening skin prick test (wheal diameter \> 3 mm)
•Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
•Signed and dated patient´s Informed Consent,

Exclusion Criteria

•Previous immunotherapy with allergen extracts within the last 3 years,
•Simultaneous participation in other clinical trials,
•Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
•Auto-immune disorders,
•Severe chronic inflammatory diseases,
•Malignancy,
•Alcohol abuse,
•Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
•Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.