The purpose of the study is to evaluate the more efficient dose for the treatment of rhinitis/rhinoconjunctivitis against mite allergy
Double blind placebo-controlled study. The subjects will receive medication during 4 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Enrollment
186
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 5.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 10.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 30.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital Del Vinalopo
Elche, Alicante, Spain
Hospital General Universitario de Elda-Virgen de La Salud
Elda, Alicante, Spain
Concentration required to elicit a positive response after nasal provocation test (NPT)
Change in the threshold concentration of mite 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
Number of participants with treatment-related adverse events as assessed by MM09-SIT-013
Comparison between the beginning and end of the trial and among active groups and placebo
Time frame: 4 months
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Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 50.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 5.000 MTU (Mannosylated Therapeutic Units)/ml sublingual
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 10.000 MTU (Mannosylated Therapeutic Units)/ml sublingual
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 30.000 MTU (Mannosylated Therapeutic Units)/ml sublingual
Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 50.000 MTU (Mannosylated Therapeutic Units)/ml sublingual
Comparison between placebo and active group
Comparison between placebo and active group
Hospital Vega Baja Orihuela
Orihuela, Alicante, Spain
Hospital Universitari de Castelló
Castellon, Castellón, Spain
Hospital de La Plana
Vila-real, Castellón, Spain
Hospital de Manises
Manises, Valencia, Spain
Hospital Lluis Alcanyis de Xátiva
Xátiva, Valencia, Spain
Hospital General Universitario de Alicante
Alicante, Spain
Hospital Vithas Internacional Medimar
Alicante, Spain
...and 4 more locations