Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Grass Pollen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00916422
Recruitment Status : Completed
First Posted : June 9, 2009
Last Update Posted : January 29, 2014
Information provided by (Responsible Party):
Laboratorios Leti, S.L.

Brief 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.

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

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  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2008
Actual Primary Completion Date : January 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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

Primary Outcome Measures :
  1. Symptoms and medication score recorded by subjects [ Time Frame: 2 year ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00916422

Fövarosi Önkormányzat Szent János Kórháza és Észak-budai Egyesített
Budapest, Hungary, 1122
AEK Jarobetegszakrendelo Intézet Pulmonologia
Budapest, Hungary, 1134
Selye jános Kórhaz-Rendelöintézet Tüdögondozó Intézet
Komárom, Hungary, 2900
Karolina Kórhaz Rendelöintézet Tüdögondozó
Mosonmagyaróvár, Hungary, 9200
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, 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 Clinico Lozano Blesa
Zaragoza, Spain
Hospital la Maz
Zaragoza, Spain
Sponsors and Collaborators
Laboratorios Leti, S.L.
Principal Investigator: Alejandro Sanchez Hospital Río Carrión

Responsible Party: Laboratorios Leti, S.L. Identifier: NCT00916422     History of Changes
Other Study ID Numbers: 2006-005868-10
First Posted: June 9, 2009    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: August 2012

Keywords provided by Laboratorios Leti, S.L.:

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