A Phase 2 interventional study of Immunotherapy with modified extract of P. pratense pollen and Placebo in Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic and Asthma, sponsored by Laboratorios Leti, S.L.. Completed at 1 site in Spain. Open to participants aged 12 Years to 50 Years. Per ClinicalTrials.gov, last updated 2010-12-17.
Sponsored by Laboratorios Leti, S.L. · Phase 2, Interventional, and Treatment
The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract of Phleum pratense in the rhinoconjunctivitis and/or asthma of slight or moderate intensity, due to allergy to grass pollen.
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 three arms of treatment: placebo and two active (one of the active arms will receive a dose that is 10x the dose of the other arm).
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 80 is below 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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The first active arm will receive a dose that is 10x less than the dose of the other arm
Biological: Immunotherapy with modified extract of P. pratense pollen
The first active arm will receive a dose that is 10x more than the dose of the other arm
Biological: Immunotherapy with modified extract of P. pratense pollen
Other: Placebo
Sublingual (2 drops daily)
Placebo 2 drops daily
Symptom scores
Time frame: 1 year
Nasal provocation test
Time frame: 1 year
Dose-response skin prick-test
Time frame: 1 year
Asthma quality of life questionnaire (AQLQ)/Rhinoconjunctivitis quality of life questionnaire (RQLQ)
Time frame: 1 year
Medication scores
Time frame: 1 year
Visual scales
Time frame: 1 year
"In vitro" immunological tests
Time frame: 1 year
Record of adverse events
Time frame: 1 year
This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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Laboratorios Leti, S.L.