Status:
COMPLETED
Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Grass Pollen
Lead Sponsor:
Laboratorios Leti, S.L.
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
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 t...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00916422
Start Date
June 1 2008
End Date
October 1 2013
Last Update
January 29 2014
Active Locations (23)
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1
Fövarosi Önkormányzat Szent János Kórháza és Észak-budai Egyesített
Budapest, Budapest, Hungary, 1122
2
AEK Jarobetegszakrendelo Intézet Pulmonologia
Budapest, Budapest, Hungary, 1134
3
Selye jános Kórhaz-Rendelöintézet Tüdögondozó Intézet
Komárom, Komárom, Hungary, 2900
4
Karolina Kórhaz Rendelöintézet Tüdögondozó
Mosonmagyaróvár, Mosonmagyaróvár, Hungary, 9200