Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Grass Pollen

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier:
NCT00916422
First received: June 5, 2009
Last updated: January 28, 2014
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Biological: Allergen extract (Phleum pratense)
Biological: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Laboratorios Leti, S.L.:

Primary Outcome Measures:
  • Symptoms and medication score recorded by subjects [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 153
Study Start Date: June 2008
Study Completion Date: October 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916422

Locations
Hungary
AEK Jarobetegszakrendelo Intézet Pulmonologia
Budapest, Hungary, 1134
Fövarosi Önkormányzat Szent János Kórháza és Észak-budai Egyesített
Budapest, Hungary, 1122
Selye jános Kórhaz-Rendelöintézet Tüdögondozó Intézet
Komárom, Hungary, 2900
Karolina Kórhaz Rendelöintézet Tüdögondozó
Mosonmagyaróvár, Hungary, 9200
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 Virgen Blanca
Leon, Spain
Hospital San Juan de Dios
Leon, Spain
Hospital San Millan
Logroño, Spain
Hospital Universitario de Getafe
Madrid, Spain, 28905
Hospital de Merida
Merida, Spain
Clinica Universitaria de Navarra
Navarra, Spain
H. Río Carrión
Palencia, Spain, 34005
Hospital del Bierzo
Ponferrada, Spain
Hospital Santa Barbara
Puertollano, Spain
Hospital de Santa Barbara
Soria, Spain
Hospital Universitario del Río Hortega
Valladolid, Spain
Hospital la Maz
Zaragoza, Spain
Hospital Clinico Lozano Blesa
Zaragoza, Spain
Sponsors and Collaborators
Laboratorios Leti, S.L.
Investigators
Principal Investigator: Alejandro Sanchez Hospital Río Carrión
  More Information

No publications provided

Responsible Party: Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier: NCT00916422     History of Changes
Other Study ID Numbers: 2006-005868-10
Study First Received: June 5, 2009
Last Updated: January 28, 2014
Health Authority: Spain: Spanish Agency of Medicines
Hungary: Research Ethics Medical Committee

Keywords provided by Laboratorios Leti, S.L.:
Immunotherapy
Allergoid
Depigmented
Polymerized
Allergen-extract
Rhinoconjunctivitis

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Hypersensitivity
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 22, 2014