Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Parietaria Judaica

Allergic Rhinoconjunctivitis Clinical Trial

Official title:

Clinical, Multi-centre, Randomised, Double-blind Placebo-controlled Subcutaneous Immunotherapy Trial With Depigmented, Polymerized Extract of Parietaria Judaica Pollen on Patients With Hypersensitivity to This Pollen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916760
• Other study ID #: 2006-005871-17
• Status: Completed
• Phase: Phase 3
• First received: June 8, 2009
• Last updated: November 8, 2013
• Start date: February 2008
• Est. completion date: February 2013

Study information

• Verified date: August 2012
• Source: Laboratorios Leti, S.L.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic
• Hypersensitivity

Intervention

Biological:
• Depigoid Parietaria judaica 1000DPP/ml
Subcutaneous monthly treatment
• Placebo
Subcutaneous monthly treatment

Locations

Country	Name	City	State
Spain	Hospital Marina Baixa	Alicante
Spain	Hospital Vega Baja	Alicante	Orihuela
Spain	H. Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Viladecans	Barcelona
Spain	Hospital de Castellón	Castellón
Spain	Hospital Reina Sofía	Murcia
Spain	Hospital Virgen de la Arrixaca	Murcia
Spain	Hospital General de Onteniente	Onteniente	Valencia
Spain	H. de sagunto	Sagunto
Spain	Hospital La Fe	Valencia
Spain	Hospital Luis Alcañiz	Xativa	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Leti, S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms score		2 years	Yes
Secondary	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	Yes