Asthma, Conjunctivitis, Allergic, Rhinitis, Allergic, Seasonal
Conditions
Keywords
Allergoid, Depigmented, Polymerized, Allergen-extract, Rhinoconjunctivitis, Asthma
Brief summary
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.
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 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).
Interventions
BIOLOGICALImmunotherapy with modified extract of P. pratense pollen
Sublingual (2 drops daily)
OTHERPlacebo
Placebo 2 drops daily
Sponsors
Laboratorios Leti, S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Positive clinical history of allergy to Phleum pratense * Patients of both gender aged from 12 up to 50 years. * Positive prick test to Phleum pratense allergen extracts * Specific IgE to Phleum pratense * Positive clinical history of allergic rhinoconjunctivitis and/or asthma * Written informed consent.
Exclusion criteria
* Use of immunotherapy during the last four years. * Any contraindication for the use of immunotherapy in accordance with European Allergy and Clinical Immunology Immunotherapy Subcommittee criteria: * Treatment with ß-blockers * Coexistence of immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role * Patients suffering from immune deficiencies * Patients with serious psychiatric / psychological disturbances * In addition, the following was considered as
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom scores | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Dose-response skin prick-test | 1 year |
| Asthma quality of life questionnaire (AQLQ)/Rhinoconjunctivitis quality of life questionnaire (RQLQ) | 1 year |
| Medication scores | 1 year |
| Nasal provocation test | 1 year |
| In vitro immunological tests | 1 year |
| Record of adverse events | 1 year |
| Visual scales | 1 year |
Countries
Spain
Outcome results
None listed