Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Grass Pollen

Phase 3

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Biological: Allergen extract (Phleum pratense); Biological: Placebo

• Registration Number: NCT00916422
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-06-05
• Study First Submitted QC: 2009-06-08
• Study First Posted: 2009-06-09
• Status Verified: 2012-08
• Primary Completion: 2013-01
• Study Completion: 2013-10
• Last Update Submitted: 2014-01-28
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Depigoid Phleum pratense 1000DPP/Ml	Allergen extract (Phleum pratense)	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.
2	Placebo	Placebo. Dosing regimen: An up-dosing cluster regimen for 4 weeks, followed by monthly injections for 2 years

Primary Outcome Measures

Name	Time	Method
Symptoms and medication score recorded by subjects	2 year

Secondary Outcome Measures

Name	Time	Method
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	2

Trial Locations

Locations (23)

Hospital la Maz; 🇪🇸 Zaragoza, Spain

Hospital de Coria; 🇪🇸 Caceres, Spain

Hospital Virgen Blanca; 🇪🇸 Leon, Spain

Hospital de Llerena; 🇪🇸 Badajoz, Spain

Hospital Militar de Burgos; 🇪🇸 Burgos, Spain

Hospital Ntra. Sra de Sonsoles; 🇪🇸 Avila, Spain

Hospital Ciudad Real; 🇪🇸 Ciudad Real, Spain

Hospital Santa Barbara; 🇪🇸 Puertollano, Spain

Hospital Universitario de Getafe; 🇪🇸 Madrid, Spain

Hospital San Millan; 🇪🇸 Logroño, Spain

Hospital Universitario del Río Hortega; 🇪🇸 Valladolid, Spain

Hospital San Juan de Dios; 🇪🇸 Leon, Spain

Hospital de Merida; 🇪🇸 Merida, Spain

AEK Jarobetegszakrendelo Intézet Pulmonologia; 🇭🇺 Budapest, Hungary

Clinica Universitaria de Navarra; 🇪🇸 Navarra, Spain

Karolina Kórhaz Rendelöintézet Tüdögondozó; 🇭🇺 Mosonmagyaróvár, Hungary

Hospital Ntra. Sra. de la Montaña; 🇪🇸 Caceres, Spain

Fövarosi Önkormányzat Szent János Kórháza és Észak-budai Egyesített; 🇭🇺 Budapest, Hungary

H. Río Carrión; 🇪🇸 Palencia, Spain

Hospital del Bierzo; 🇪🇸 Ponferrada, Spain

Hospital de Santa Barbara; 🇪🇸 Soria, Spain

Hospital Clinico Lozano Blesa; 🇪🇸 Zaragoza, Spain

Selye jános Kórhaz-Rendelöintézet Tüdögondozó Intézet; 🇭🇺 Komárom, Hungary