Allergic Rhinitis
Conditions
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.
Interventions
BIOLOGICALAllergen extract
sublingual application
BIOLOGICALPlacebo
sublingual application
Sponsors
Roxall Medizin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom and medication score | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Safety of sublingual application | 1 year |
| Protocol of adverse events | 1 year |
| Quality of Life Questionnaire | 1 year |
| Evaluation of patients' related clinical global improvement | 1 year |
Countries
Spain
Contacts
Primary ContactRoxall Medizin
Outcome results
None listed