Allergic Conjunctivitis, Allergic Rhinitis
Conditions
Brief summary
This trial is performed to evaluate the safety and clinical efficacy of subcutaneous specific immunotherapy in patients suffering from seasonal allergic rhinitis/rhinoconjunctivitis.
Interventions
BIOLOGICALmodified allergen extract
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Positive history of allergen specific allergic rhinitis/rhinoconjunctivitis * 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 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 |
| Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | 1 year |
| Clinical global improvement | 1 year |
Countries
Germany
Contacts
Primary ContactRoxall Medizin
Outcome results
None listed