Status:
COMPLETED
Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Parietaria Judaica
Lead Sponsor:
Laboratorios Leti, S.L.
Conditions:
Allergic Rhinoconjunctivitis
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
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 t...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00916760
Start Date
February 1 2008
End Date
February 1 2013
Last Update
November 11 2013
Active Locations (11)
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1
H. Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
2
Hospital Viladecans
Barcelona, Barcelona, Spain, 08840
3
Hospital Vega Baja
Alicante, Orihuela, Spain, 03314
4
H. de sagunto
Sagunto, Sagunto, Spain, 46520