Allergic Rhinoconjunctivitis
Conditions
Keywords
allergic, rhinoconjunctivitis, Immunotherapy
Brief summary
The objective of this trial is to assess the clinical efficacy of the modified extract (depigmented and polymerized with glutaraldehyde) of the subcutaneous injection of Parietaria Judaica pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis ( with or without episodic asthma) induced by hypersensitivity to grass pollen, evaluating the score regarding symptoms and consumption of the medication.
Detailed description
Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo controlled study with two arms of treatment: placebo and active.
Interventions
BIOLOGICALDepigoid Parietaria judaica 1000DPP/ml
Subcutaneous monthly treatment
BIOLOGICALPlacebo
Subcutaneous monthly treatment
Sponsors
Laboratorios Leti, S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent, signed by the subject * Positive clinical history of rhinitis/rhinoconjunctivitis allergy to Parietaria pollen * Patient of both gender aged from 18 up to 55 * Diagnosed Sensitivity to Parietaria pollen base on: Positive Nasal provocation test Positive prick test to P. Judaica Specific IgE to P.Judaica \>0,7KU/L \- Patients who are able to comply with the dose regime
Exclusion criteria
* Relevant sensitivity to another perenne allergen * Patient with asthma * Use of immunotherapy during the last four years * Treatment with B. Blocking agents * Patient suffering from some pathology in which adrenaline was contraindicated * Subject suffers from a serious medical condition, which would interference the treatment and follow up of the subject in the study * Subject suffers from autoimmune disease(thyroiditis, lupus, etc.) * Conditions in which the patient can not offer full co-operation nad significant psychiatric disturbance. * Intolerance to aspirin * Pregnant women or with pregnancy risk and brest-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms score | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Nasal Provocation test, Dose- response skin prick test, Quality of life questionnaire, visual scales, asthma symptom scores, Medication scores, adverse event and severity adverse event,unplanned healthcare resource utilization | 2 years |
Countries
Spain
Outcome results
None listed