Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Parietaria Judaica

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00916760
Recruitment Status : Completed
First Posted : June 10, 2009
Last Update Posted : November 11, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Allergic Rhinoconjunctivitis Biological: Depigoid Parietaria judaica 1000DPP/ml Biological: Placebo Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : February 2008
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Aluminum

Arm Intervention/treatment
Experimental: 1
A Subcutaneous Depigmented and Polymerized Allergen extract of Parietaria Judaica 1000 DPP/ml. Depigoid Parietaria judaica 1000 DPP/ml.
Biological: Depigoid Parietaria judaica 1000DPP/ml
Subcutaneous monthly treatment
Other Name: A suspension of depigmented and glutaraldehyde-polymerised allergen extract of Parietaria judaica adsorbed onto aluminium hydroxide.

Placebo Comparator: 2 Biological: Placebo
Subcutaneous monthly treatment

Primary Outcome Measures :
  1. Symptoms score [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 2 years ]

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00916760

H. Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Vega Baja
Alicante, Orihuela, Spain, 03314
Hospital General de Onteniente
Onteniente, Valencia, Spain
Hospital Luis Alcañiz
Xativa, Valencia, Spain
Hospital Marina Baixa
Alicante, Spain
Hospital Viladecans
Barcelona, Spain, 08840
Hospital de Castellón
Castellón, Spain
Hospital Reina Sofía
Murcia, Spain
Hospital Virgen de la Arrixaca
Murcia, Spain
H. de sagunto
Sagunto, Spain, 46520
Hospital La Fe
Valencia, Spain
Sponsors and Collaborators
Laboratorios Leti, S.L.
Principal Investigator: Angel Ferrer, Dr Hospital Vega Baja

Responsible Party: Laboratorios Leti, S.L. Identifier: NCT00916760     History of Changes
Other Study ID Numbers: 2006-005871-17
First Posted: June 10, 2009    Key Record Dates
Last Update Posted: November 11, 2013
Last Verified: August 2012

Keywords provided by Laboratorios Leti, S.L.:
allergic, rhinoconjunctivitis, Immunotherapy

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Aluminum Hydroxide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents