Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Grass Pollen

Seasonal Allergic Rhinitis Clinical Trial

Official title:

Clinical, Multi-centre,Randomized, Double-blind, Placebo-controlled Subcutaneous Immunotherapy Trial With Depigmented, Polymerised Extract of Phleum Pratense Pollen on Patients With Hypersensitivity to Grass Pollen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916422
• Other study ID #: 2006-005868-10
• Status: Completed
• Phase: Phase 3
• First received: June 5, 2009
• Last updated: January 28, 2014
• Start date: June 2008
• Est. completion date: October 2013

Study information

• Verified date: August 2012
• Source: Laboratorios Leti, S.L.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesHungary: Research Ethics Medical Committee
• Study type: Interventional

Clinical Trial Summary

The objective of this trial is to assess the clinical efficacy of the modified extract (depigmented and polymerised with glutaraldehyde)of the subcutaneous injection of Phleum pratense 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.

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 in an up-dosing cluster regimen for 4 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: October 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Informed consent, signed by the subject.

• Clinical History of moderate to severe rhinitis/rhinoconjunctivitis lasting for at least 2 consecutive years, with or without episodic asthma, caused by allergy to grass pollen.

• Patient of both gender aged from 18 up to 55

• Symptoms that coincide with allergy to grass pollen

• Sensitivity to grass pollen, diagnosed through a positive skin reaction to Phleum pratense: Positive prick test and /or Specific IgE to P.pratense >0,7KU/L Patients included must be mono-sensitised or, in the case of poly-sensitisation, sensitivity to p.pratense pollen should be considered as the only relevant aspect of their condition from the clinical standpoint.

• Patients who are able to comply with the dose regime

Exclusion Criteria:

• Patient with mild Rhinitis/rhinoconjunctivitis

• Relevant sensitivity to another perennial allergen

• Use of immunotherapy during the last four years

• Treatment with B. Blocking agents

• Patient suffering from some pathology in which adrenalin 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 and significant psychiatric disorders.

• Intolerance to aspirin

• Pregnant women or with pregnancy risk and breast-feeding

Study Design

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

Related Conditions & MeSH terms

• Hypersensitivity
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Biological:
• Allergen extract (Phleum pratense)
Subcutaneous immunotherapy with modified extract of Phleum pratense. A subcutaneous monthly treatment.
• Placebo
Subcutaneous monthly treatment

Locations

Country	Name	City	State
Hungary	AEK Jarobetegszakrendelo Intézet Pulmonologia	Budapest
Hungary	Fövarosi Önkormányzat Szent János Kórháza és Észak-budai Egyesített	Budapest
Hungary	Selye jános Kórhaz-Rendelöintézet Tüdögondozó Intézet	Komárom
Hungary	Karolina Kórhaz Rendelöintézet Tüdögondozó	Mosonmagyaróvár
Spain	Hospital Ntra. Sra de Sonsoles	Avila
Spain	Hospital de Llerena	Badajoz
Spain	Hospital Militar de Burgos	Burgos
Spain	Hospital de Coria	Caceres
Spain	Hospital Ntra. Sra. de la Montaña	Caceres
Spain	Hospital Ciudad Real	Ciudad Real
Spain	Hospital San Juan de Dios	Leon
Spain	Hospital Virgen Blanca	Leon
Spain	Hospital San Millan	Logroño
Spain	Hospital Universitario de Getafe	Madrid
Spain	Hospital de Merida	Merida
Spain	Clinica Universitaria de Navarra	Navarra
Spain	H. Río Carrión	Palencia
Spain	Hospital del Bierzo	Ponferrada
Spain	Hospital Santa Barbara	Puertollano
Spain	Hospital de Santa Barbara	Soria
Spain	Hospital Universitario del Río Hortega	Valladolid
Spain	Hospital Clinico Lozano Blesa	Zaragoza
Spain	Hospital la Maz	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Leti, S.L.

Countries where clinical trial is conducted

Hungary,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms and medication score recorded by subjects		2 year	Yes
Secondary	Nasal provocation test, Dose-response skin prick test, Rhinoconjunctivitis Quality of life questionnaire, visual scales, asthma symptom scores, medication scores, adverse event and severity adverse event, unplanned health care resource utilization		2	No