The purpose of the study is to evaluate the more efficient dose for the treatment of rhinitis/rhinoconjunctivitis against grass pollen allergy
Double blind placebo-controlled study. The subjects will receive medication during 4 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Enrollment
180
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 500 mTU (Mannosylated Therapeutic Units)/ml subcutaneous
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 1000 mTU (Mannosylated Therapeutic Units)/ml subcutaneous
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 3000 mTU (Mannosylated Therapeutic Units)/ml subcutaneous
Clínica Atlas
Aranjuez, Madrid, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Universitario Infanta Elena
Valdemoro, Madrid, Spain
Concentration required to elicit a positive response after nasal provocation test (NPT)
Change in the threshold concentration of grass allergen extract, measured in Histamine Equivalent Prick per ml (HEP/ml), needed to trigger a positive response after nasal provocation test (NPT) assessed by acoustic rhinometry. This will be compared between the beginning and end of the trial and among active groups and placebo.
Time frame: 4 months
Dose finding skin prick test
Comparison between the beginning and end of the trial and among active groups and placebo
Time frame: 4 months
Cytokine production by T cells specific allergen
Comparison between the beginning and end of the trial and among active groups and placebo
Time frame: 4 months
Immunoglobulin production by B cells specific allergen
Comparison between the beginning and end of the trial and among active groups and placebo
Time frame: 4 months
Phenotypic and functional analysis of dendritic cells
Will be analyzed changes in the frequency of plasmacytoid dendritic cells, myeloid dendritic cell and Treg cells in peripheral blood, between the beginning and end of the trial and among active groups and placebo The frequencies of peripheral blood mononuclear cells in each of the above populations is determined before and after treatment with mannosylated polymers by flow cytometry after staining with specific antibodies.
Time frame: 4 months
Number of participants with treatment-related adverse events as assessed by MG56-SIT-012
Comparison between the beginning and end of the trial and among active groups and placebo
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Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 5000 mTU (Mannosylated Therapeutic Units)/ml subcutaneous
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 500 mTU (Mannosylated Therapeutic Units)/ml sublingual
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 1000 mTU (Mannosylated Therapeutic Units)/ml sublingual
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 3000 mTU (Mannosylated Therapeutic Units)/ml sublingual
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 5000 mTU (Mannosylated Therapeutic Units)/ml sublingual
Comparison between placebo and active group
Comparison between placebo and active group
Hospital Nisa Aljarafe
Castilleja de la Cuesta, Sevilla, Spain
Hospital San Agustín
Dos Hermanas, Sevilla, Spain
CLÍNICA Dr. SUBIZA
Madrid, Spain
Clínica Ojeda
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
HOSPITAL UNIVERSITARIO 12 de OCTUBRE
Madrid, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
...and 2 more locations
Time frame: 4 months