Clinical trial NCT00916760: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinoconjunctivitis
Keywords: allergic, rhinoconjunctivitis, Immunotherapy
Lead sponsor: Laboratorios Leti, S.L.
Sponsor class: INDUSTRY
First posted: 2009-06-10
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Symptoms score
timeFrame: 2 years
Secondary outcomes:
measure: 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
timeFrame: 2 years
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: H. Germans Trias i Pujol
state: Barcelona
city: Alicante
country: Spain
facility: Hospital Vega Baja
state: Orihuela
city: Onteniente
country: Spain
facility: Hospital General de Onteniente
state: Valencia
city: Xativa
country: Spain
facility: Hospital Luis Alcañiz
state: Valencia
city: Alicante
country: Spain
facility: Hospital Marina Baixa
city: Barcelona
country: Spain
facility: Hospital Viladecans
city: Castellón
country: Spain
facility: Hospital de Castellón
city: Murcia
country: Spain
facility: Hospital Reina Sofía
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Sagunto
country: Spain
facility: H. de sagunto
city: Valencia
country: Spain
facility: Hospital La Fe
Study officials:
affiliation: Hospital Vega Baja
name: Angel Ferrer, Dr
role: PRINCIPAL_INVESTIGATOR
References: