Clinical trial NCT00916422: Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Grass Pollen
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Keywords: Immunotherapy
Allergoid
Depigmented
Polymerized
Allergen-extract
Rhinoconjunctivitis
Lead sponsor: Laboratorios Leti, S.L.
Sponsor class: INDUSTRY
First posted: 2009-06-09
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Symptoms and medication score recorded by subjects
timeFrame: 2 year
Secondary outcomes:
measure: 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
timeFrame: 2
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Fövarosi Önkormányzat Szent János Kórháza és Észak-budai Egyesített
city: Budapest
country: Hungary
facility: AEK Jarobetegszakrendelo Intézet Pulmonologia
city: Komárom
country: Hungary
facility: Selye jános Kórhaz-Rendelöintézet Tüdögondozó Intézet
city: Mosonmagyaróvár
country: Hungary
facility: Karolina Kórhaz Rendelöintézet Tüdögondozó
city: Avila
country: Spain
facility: Hospital Ntra. Sra de Sonsoles
city: Badajoz
country: Spain
facility: Hospital de Llerena
city: Burgos
country: Spain
facility: Hospital Militar de Burgos
city: Caceres
country: Spain
facility: Hospital de Coria
city: Caceres
country: Spain
facility: Hospital Ntra. Sra. de la Montaña
city: Ciudad Real
country: Spain
facility: Hospital Ciudad Real
city: Leon
country: Spain
facility: Hospital San Juan de Dios
city: Leon
country: Spain
facility: Hospital Virgen Blanca
city: Logroño
country: Spain
facility: Hospital San Millan
city: Madrid
country: Spain
facility: Hospital Universitario de Getafe
city: Merida
country: Spain
facility: Hospital de Merida
city: Navarra
country: Spain
facility: Clinica Universitaria de Navarra
city: Palencia
country: Spain
facility: H. Río Carrión
city: Ponferrada
country: Spain
facility: Hospital del Bierzo
city: Puertollano
country: Spain
facility: Hospital Santa Barbara
city: Soria
country: Spain
facility: Hospital de Santa Barbara
city: Valladolid
country: Spain
facility: Hospital Universitario del Río Hortega
city: Zaragoza
country: Spain
facility: Hospital Clinico Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital la Maz
Study officials:
affiliation: Hospital Río Carrión
name: Alejandro Sanchez
role: PRINCIPAL_INVESTIGATOR
References: