A Phase 3 interventional study of Allergen extract (Phleum pratense) and Placebo in Seasonal Allergic Rhinitis, sponsored by Laboratorios Leti, S.L.. Completed at 23 sites in 2 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2014-01-29.
Sponsored by Laboratorios Leti, S.L. · Phase 3, Interventional, and Treatment
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.
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.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 153 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Laboratorios Leti, S.L. is the lead sponsor of 24 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Biological: Allergen extract (Phleum pratense)
Placebo. Dosing regimen: An up-dosing cluster regimen for 4 weeks, followed by monthly injections for 2 years
Biological: Placebo
Subcutaneous immunotherapy with modified extract of Phleum pratense. A subcutaneous monthly treatment.
Subcutaneous monthly treatment
Symptoms and medication score recorded by subjects
Time frame: 2 year
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
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Laboratorios Leti, S.L.