Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Grass Pollen

NCT ID: NCT00916422

Last Updated: 2014-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2013-10-31

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.

Conditions

Seasonal Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Allergen extract (Phleum pratense)

Intervention Type: BIOLOGICAL

Subcutaneous immunotherapy with modified extract of Phleum pratense. A subcutaneous monthly treatment.

2

Placebo. Dosing regimen: An up-dosing cluster regimen for 4 weeks, followed by monthly injections for 2 years

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Subcutaneous monthly treatment

Interventions

Allergen extract (Phleum pratense)

Subcutaneous immunotherapy with modified extract of Phleum pratense. A subcutaneous monthly treatment.

Intervention Type: BIOLOGICAL

Placebo

Subcutaneous monthly treatment

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratorios Leti, S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alejandro Sanchez

Role: PRINCIPAL_INVESTIGATOR

Hospital Río Carrión

Locations

Fövarosi Önkormányzat Szent János Kórháza és Észak-budai Egyesített

Budapest, Budapest, Hungary

AEK Jarobetegszakrendelo Intézet Pulmonologia

Budapest, Budapest, Hungary

Selye jános Kórhaz-Rendelöintézet Tüdögondozó Intézet

Komárom, Komárom, Hungary

Karolina Kórhaz Rendelöintézet Tüdögondozó

Mosonmagyaróvár, Mosonmagyaróvár, Hungary

Hospital Universitario de Getafe

Madrid, Madrid, Spain

H. Río Carrión

Palencia, Palencia, Spain

Hospital Ntra. Sra de Sonsoles

Ávila, , Spain

Hospital de Llerena

Badajoz, , Spain

Hospital Militar de Burgos

Burgos, , Spain

Hospital de Coria

Cáceres, , Spain

Hospital Ntra. Sra. de la Montaña

Cáceres, , Spain

Hospital Ciudad Real

Ciudad Real, , Spain

Hospital San Juan de Dios

León, , Spain

Hospital Virgen Blanca

León, , Spain

Hospital San Millan

Logroño, , Spain

Hospital de Merida

Mérida, , Spain

Clinica Universitaria de Navarra

Navarra, , Spain

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

Countries

Hungary; Spain

Other Identifiers

2006-005868-10

Identifier Type: -

Identifier Source: org_study_id