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Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Parietaria Judaica

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00916760
First Posted: June 10, 2009
Last Update Posted: November 11, 2013
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.
Information provided by (Responsible Party):
Laboratorios Leti, S.L.
June 8, 2009
June 10, 2009
November 11, 2013
February 2008
February 2013   (Final data collection date for primary outcome measure)
Symptoms score [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT00916760 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Parietaria Judaica
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
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Allergic Rhinoconjunctivitis
  • 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.
  • Biological: Placebo
    Subcutaneous monthly treatment
  • Experimental: 1
    A Subcutaneous Depigmented and Polymerized Allergen extract of Parietaria Judaica 1000 DPP/ml. Depigoid Parietaria judaica 1000 DPP/ml.
    Intervention: Biological: Depigoid Parietaria judaica 1000DPP/ml
  • Placebo Comparator: 2
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
153
February 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00916760
2006-005871-17
No
Not Provided
Not Provided
Laboratorios Leti, S.L.
Laboratorios Leti, S.L.
Not Provided
Principal Investigator: Angel Ferrer, Dr Hospital Vega Baja
Laboratorios Leti, S.L.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP