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
1 other identifier
interventional
153
2 countries
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2008
Longer than P75 for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 5, 2009
CompletedFirst Posted
Study publicly available on registry
June 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedJanuary 29, 2014
August 1, 2012
4.6 years
June 5, 2009
January 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Symptoms and medication score recorded by subjects
2 year
Secondary Outcomes (1)
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
Study Arms (2)
Depigoid Phleum pratense 1000DPP/Ml
EXPERIMENTALDepigmented 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 COMPARATORPlacebo. Dosing regimen: An up-dosing cluster regimen for 4 weeks, followed by monthly injections for 2 years
Interventions
Subcutaneous immunotherapy with modified extract of Phleum pratense. A subcutaneous monthly treatment.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Fövarosi Önkormányzat Szent János Kórháza és Észak-budai Egyesített
Budapest, Budapest, 1122, Hungary
AEK Jarobetegszakrendelo Intézet Pulmonologia
Budapest, Budapest, 1134, Hungary
Selye jános Kórhaz-Rendelöintézet Tüdögondozó Intézet
Komárom, Komárom, 2900, Hungary
Karolina Kórhaz Rendelöintézet Tüdögondozó
Mosonmagyaróvár, Mosonmagyaróvár, 9200, Hungary
Hospital Universitario de Getafe
Madrid, Madrid, 28905, Spain
H. Río Carrión
Palencia, Palencia, 34005, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alejandro Sanchez
Hospital Río Carrión
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2009
First Posted
June 9, 2009
Study Start
June 1, 2008
Primary Completion
January 1, 2013
Study Completion
October 1, 2013
Last Updated
January 29, 2014
Record last verified: 2012-08