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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: September 2017

Interventions

  • Biological: Allergen extract
    • sublingual application
  • Biological: Placebo
    • sublingual application

Arms, Groups and Cohorts

  • Experimental: Allergen extract
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Symptom and medication score
    • Time Frame: 1 year

Secondary Measures

  • Safety of sublingual application
    • Time Frame: 1 year
  • Protocol of adverse events
    • Time Frame: 1 year
  • Quality of Life Questionnaire
    • Time Frame: 1 year
  • Evaluation of patients’ related clinical global improvement
    • Time Frame: 1 year

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Roxall Medizin
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Roxall Medizin, +49408972520

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