Back to resultsSubcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Parietaria Judaica
Primary Purpose
Allergic Rhinoconjunctivitis
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Depigoid Parietaria judaica 1000DPP/ml
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinoconjunctivitis focused on measuring allergic, rhinoconjunctivitis, Immunotherapy
Eligibility 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
Sites / Locations
- H. Germans Trias i Pujol
- Hospital Vega Baja
- Hospital General de Onteniente
- Hospital Luis Alcañiz
- Hospital Marina Baixa
- Hospital Viladecans
- Hospital de Castellón
- Hospital Reina Sofía
- Hospital Virgen de la Arrixaca
- H. de sagunto
- Hospital La Fe
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
A Subcutaneous Depigmented and Polymerized Allergen extract of Parietaria Judaica 1000 DPP/ml. Depigoid Parietaria judaica 1000 DPP/ml.
Outcomes
Primary Outcome Measures
Symptoms score
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00916760
Brief Title
Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Parietaria Judaica
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 Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Leti, S.L.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinoconjunctivitis
Keywords
allergic, rhinoconjunctivitis, Immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
A Subcutaneous Depigmented and Polymerized Allergen extract of Parietaria Judaica 1000 DPP/ml. Depigoid Parietaria judaica 1000 DPP/ml.
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Depigoid Parietaria judaica 1000DPP/ml
Other Intervention Name(s)
A suspension of depigmented and glutaraldehyde-polymerised allergen extract of Parietaria judaica adsorbed onto aluminium hydroxide.
Intervention Description
Subcutaneous monthly treatment
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous monthly treatment
Primary Outcome Measure Information:
Title
Symptoms score
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angel Ferrer, Dr
Organizational Affiliation
Hospital Vega Baja
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Vega Baja
City
Alicante
State/Province
Orihuela
ZIP/Postal Code
03314
Country
Spain
Facility Name
Hospital General de Onteniente
City
Onteniente
State/Province
Valencia
Country
Spain
Facility Name
Hospital Luis Alcañiz
City
Xativa
State/Province
Valencia
Country
Spain
Facility Name
Hospital Marina Baixa
City
Alicante
Country
Spain
Facility Name
Hospital Viladecans
City
Barcelona
ZIP/Postal Code
08840
Country
Spain
Facility Name
Hospital de Castellón
City
Castellón
Country
Spain
Facility Name
Hospital Reina Sofía
City
Murcia
Country
Spain
Facility Name
Hospital Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
H. de sagunto
City
Sagunto
ZIP/Postal Code
46520
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Parietaria Judaica
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