Back to resultsSubcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Grass Pollen
Primary Purpose
Seasonal Allergic Rhinitis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Allergen extract (Phleum pratense)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring Immunotherapy, Allergoid, Depigmented, Polymerized, Allergen-extract, Rhinoconjunctivitis
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
Sites / Locations
- Fövarosi Önkormányzat Szent János Kórháza és Észak-budai Egyesített
- AEK Jarobetegszakrendelo Intézet Pulmonologia
- Selye jános Kórhaz-Rendelöintézet Tüdögondozó Intézet
- Karolina Kórhaz Rendelöintézet Tüdögondozó
- Hospital Ntra. Sra de Sonsoles
- Hospital de Llerena
- Hospital Militar de Burgos
- Hospital de Coria
- Hospital Ntra. Sra. de la Montaña
- Hospital Ciudad Real
- Hospital San Juan de Dios
- Hospital Virgen Blanca
- Hospital San Millan
- Hospital Universitario de Getafe
- Hospital de Merida
- Clinica Universitaria de Navarra
- H. Río Carrión
- Hospital del Bierzo
- Hospital Santa Barbara
- Hospital de Santa Barbara
- Hospital Universitario del Río Hortega
- Hospital Clinico Lozano Blesa
- Hospital la Maz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Depigoid Phleum pratense 1000DPP/Ml
2
Arm Description
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.
Placebo. Dosing regimen: An up-dosing cluster regimen for 4 weeks, followed by monthly injections for 2 years
Outcomes
Primary Outcome Measures
Symptoms and medication score recorded by subjects
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00916422
Brief Title
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
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Leti, S.L.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
Keywords
Immunotherapy, Allergoid, Depigmented, Polymerized, Allergen-extract, Rhinoconjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Depigoid Phleum pratense 1000DPP/Ml
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo. Dosing regimen: An up-dosing cluster regimen for 4 weeks, followed by monthly injections for 2 years
Intervention Type
Biological
Intervention Name(s)
Allergen extract (Phleum pratense)
Intervention Description
Subcutaneous immunotherapy with modified extract of Phleum pratense. A subcutaneous monthly treatment.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous monthly treatment
Primary Outcome Measure Information:
Title
Symptoms and medication score recorded by subjects
Time Frame
2 year
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro Sanchez
Organizational Affiliation
Hospital Río Carrión
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fövarosi Önkormányzat Szent János Kórháza és Észak-budai Egyesített
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
AEK Jarobetegszakrendelo Intézet Pulmonologia
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Selye jános Kórhaz-Rendelöintézet Tüdögondozó Intézet
City
Komárom
ZIP/Postal Code
2900
Country
Hungary
Facility Name
Karolina Kórhaz Rendelöintézet Tüdögondozó
City
Mosonmagyaróvár
ZIP/Postal Code
9200
Country
Hungary
Facility Name
Hospital Ntra. Sra de Sonsoles
City
Avila
Country
Spain
Facility Name
Hospital de Llerena
City
Badajoz
Country
Spain
Facility Name
Hospital Militar de Burgos
City
Burgos
Country
Spain
Facility Name
Hospital de Coria
City
Caceres
Country
Spain
Facility Name
Hospital Ntra. Sra. de la Montaña
City
Caceres
Country
Spain
Facility Name
Hospital Ciudad Real
City
Ciudad Real
Country
Spain
Facility Name
Hospital San Juan de Dios
City
Leon
Country
Spain
Facility Name
Hospital Virgen Blanca
City
Leon
Country
Spain
Facility Name
Hospital San Millan
City
Logroño
Country
Spain
Facility Name
Hospital Universitario de Getafe
City
Madrid
ZIP/Postal Code
28905
Country
Spain
Facility Name
Hospital de Merida
City
Merida
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Navarra
Country
Spain
Facility Name
H. Río Carrión
City
Palencia
ZIP/Postal Code
34005
Country
Spain
Facility Name
Hospital del Bierzo
City
Ponferrada
Country
Spain
Facility Name
Hospital Santa Barbara
City
Puertollano
Country
Spain
Facility Name
Hospital de Santa Barbara
City
Soria
Country
Spain
Facility Name
Hospital Universitario del Río Hortega
City
Valladolid
Country
Spain
Facility Name
Hospital Clinico Lozano Blesa
City
Zaragoza
Country
Spain
Facility Name
Hospital la Maz
City
Zaragoza
Country
Spain
12. IPD Sharing Statement
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Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Grass Pollen
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