Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Parietaria Judaica

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier:
NCT00916760
First received: June 8, 2009
Last updated: November 8, 2013
Last verified: August 2012
  Purpose

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 Intervention Phase
Allergic Rhinoconjunctivitis
Biological: Depigoid Parietaria judaica 1000DPP/ml
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Laboratorios Leti, S.L.:

Primary Outcome Measures:
  • Symptoms score [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 153
Study Start Date: February 2008
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916760

Locations
Spain
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.
Investigators
Principal Investigator: Angel Ferrer, Dr Hospital Vega Baja
  More Information

No publications provided

Responsible Party: Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier: NCT00916760     History of Changes
Other Study ID Numbers: 2006-005871-17
Study First Received: June 8, 2009
Last Updated: November 8, 2013
Health Authority: Spain: Spanish Agency of Medicines

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

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

ClinicalTrials.gov processed this record on August 28, 2014