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Completed

NCT Number: NCT00916760

Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Parietaria Judaica

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

H. Germans Trias i Pujol, Badalona, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Depigoid Parietaria judaica 1000DPP/ml

Biological

Subcutaneous monthly treatment

Other names: A suspension of depigmented and glutaraldehyde-polymerised allergen extract of Parietaria judaica adsorbed onto aluminium hydroxide.

Placebo

Biological

Subcutaneous monthly treatment

Primary outcomes

  1. Symptoms score

    Time frame: 2 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Laboratorios Leti, S.L.

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jun 10, 2009
Registry last updated
Nov 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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