Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Parietaria Judaica

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Laboratorios Leti, S.L.

ClinicalTrials.gov Identifier:

NCT00916760

First received: June 8, 2009

Last updated: August 27, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 8, 2009

Last Updated Date

August 27, 2012

Start Date ^ICMJE

February 2008

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Symptoms score [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Symptoms score [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00916760 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Parietaria Judaica

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Allergic Rhinoconjunctivitis

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

January 2013

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT00916760

Other Study ID Numbers ^ICMJE

2006-005871-17

Has Data Monitoring Committee

Responsible Party

Laboratorios Leti, S.L.

Study Sponsor ^ICMJE

Laboratorios Leti, S.L.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Angel Ferrer, Dr

Hospital Vega Baja

Information Provided By

Laboratorios Leti, S.L.

Verification Date

August 2012

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

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