Allergic Rhinitis
Conditions
Brief summary
The objective of this study is to evaluate the efficacy and safety of specific subcutaneous immunotherapy with modified allergen extracts.
Interventions
BIOLOGICALmodified allergen extract of house dust mites
subcutaneous injections
BIOLOGICALplacebo
subcutaneous injections
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 due to house dust mites * 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 mite 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 the treatment | 1 year |
| Documentation of adverse events | 1 year |
| Clinical global improvement | 1 year |
| Quality of Life Questionnaire | 1 year |
Countries
Spain
Contacts
Primary ContactRoxall Medizin
Outcome results
None listed