Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Parietaria Judaica

Phase 3

Completed

• Conditions: Allergic Rhinoconjunctivitis
• Interventions: Biological: Depigoid Parietaria judaica 1000DPP/ml; Biological: Placebo

• Registration Number: NCT00916760
• Lead Sponsor: Laboratorios Leti, S.L.

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2009-06-08
• Study First Submitted QC: 2009-06-09
• Study First Posted: 2009-06-10
• Status Verified: 2012-08
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Last Update Submitted: 2013-11-08
• Last Update Posted: 2013-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Depigoid Parietaria judaica 1000DPP/ml	A Subcutaneous Depigmented and Polymerized Allergen extract of Parietaria Judaica 1000 DPP/ml. Depigoid Parietaria judaica 1000 DPP/ml.
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Symptoms score	2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (11)

Hospital Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Hospital Vega Baja; 🇪🇸 Alicante, Orihuela, Spain

H. Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital de Castellón; 🇪🇸 Castellón, Spain

Hospital Luis Alcañiz; 🇪🇸 Xativa, Valencia, Spain

Hospital Reina Sofía; 🇪🇸 Murcia, Spain

Hospital General de Onteniente; 🇪🇸 Onteniente, Valencia, Spain

Hospital Viladecans; 🇪🇸 Barcelona, Spain

Hospital Marina Baixa; 🇪🇸 Alicante, Spain

H. de sagunto; 🇪🇸 Sagunto, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain