Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Grass Pollen

January 28, 2014 updated by: Laboratorios Leti, S.L.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 in an up-dosing cluster regimen for 4 weeks.

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1122
        • Fövarosi Önkormányzat Szent János Kórháza és Észak-budai Egyesített
      • Budapest, Hungary, 1134
        • AEK Jarobetegszakrendelo Intézet Pulmonologia
      • Komárom, Hungary, 2900
        • Selye jános Kórhaz-Rendelöintézet Tüdögondozó Intézet
      • Mosonmagyaróvár, Hungary, 9200
        • Karolina Kórhaz Rendelöintézet Tüdögondozó
  • Spain
      • Avila, Spain
        • Hospital Ntra. Sra de Sonsoles
      • Badajoz, Spain
        • Hospital de Llerena
      • Burgos, Spain
        • Hospital Militar de Burgos
      • Caceres, Spain
        • Hospital de Coria
      • Caceres, Spain
        • Hospital Ntra. Sra. de la Montaña
      • Ciudad Real, Spain
        • Hospital Ciudad Real
      • Leon, Spain
        • Hospital Virgen Blanca
      • Leon, Spain
        • Hospital San Juan de Dios
      • Logroño, Spain
        • Hospital San Millan
      • Madrid, Spain, 28905
        • Hospital Universitario de Getafe
      • Merida, Spain
        • Hospital de Mérida
      • Navarra, Spain
        • Clinica Universitaria de Navarra
      • Palencia, Spain, 34005
        • H. Río Carrión
      • Ponferrada, Spain
        • Hospital del Bierzo
      • Puertollano, Spain
        • Hospital Santa Bárbara
      • Soria, Spain
        • Hospital de Santa Barbara
      • Valladolid, Spain
        • Hospital Universitario del Río Hortega
      • Zaragoza, Spain
        • Hospital Clinico Lozano Blesa
      • Zaragoza, Spain
        • Hospital la Maz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Depigoid Phleum pratense 1000DPP/Ml
Depigmented and Polymerized Allergen extract of Phleum Pratense.Subcutaneous Immunotherapy in an up-dosing cluster regimen for 4 weeks, followed by monthly injections for 2 years.
Biological: Allergen extract (Phleum pratense)
Subcutaneous immunotherapy with modified extract of Phleum pratense. A subcutaneous monthly treatment.
Placebo Comparator: 2
Placebo. Dosing regimen: An up-dosing cluster regimen for 4 weeks, followed by monthly injections for 2 years
Biological: Placebo
Subcutaneous monthly treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptoms and medication score recorded by subjects
Time Frame: 2 year
2 year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 2
2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Leti, S.L.

Investigators

  • Principal Investigator: Alejandro Sanchez, Hospital Río Carrión

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

June 5, 2009

First Submitted That Met QC Criteria

June 8, 2009

First Posted (Estimate)

June 9, 2009

Study Record Updates

Last Update Posted (Estimate)

January 29, 2014

Last Update Submitted That Met QC Criteria

January 28, 2014

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-005868-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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