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Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Grass Pollen

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier:
NCT00916422
First received: June 5, 2009
Last updated: August 27, 2012
Last verified: August 2012
History of Changes

June 5, 2009
August 27, 2012
January 2008
July 2012   (final data collection date for primary outcome measure)
Symptoms and medication score recorded by subjects [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
Symptoms score [ Time Frame: 2 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00916422 on ClinicalTrials.gov Archive Site
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 ]
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 health care resource utilization [ Time Frame: 2 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Grass Pollen
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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Seasonal Allergic Rhinitis
  • Biological: Allergen extract (Phleum pratense)
    Subcutaneous immunotherapy with modified extract of Phleum pratense. A subcutaneous monthly treatment.
  • Biological: Placebo
    Subcutaneous monthly 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.
    Intervention: Biological: Allergen extract (Phleum pratense)
  • Placebo Comparator: 2
    Placebo. Dosing regimen: An up-dosing cluster regimen for 4 weeks, followed by monthly injections for 2 years
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
November 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Hungary,   Spain
 
NCT00916422
2006-005868-10
No
Laboratorios Leti, S.L.
Laboratorios Leti, S.L.
Not Provided
Principal Investigator: Alejandro Sanchez Hospital Río Carrión
Laboratorios Leti, S.L.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP