Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic diseases the aim of this study was to assess safety and tolerability of 3 different subcutaneous immunotherapy dose escalations in patients allergic to Dermatophagoides pteronyssinus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
Increasing doses of subcutaneous depot placebo in three different scales
Hospital de Basurto
Bilbao, Vizcaya, Spain
Hospital La Fe
Valencia, Spain
Number and Seriousness of Both Local and Systemic Adverse Reactions
The primary end points were the number of ARs and the severity of local and systemic ARs (SARs) to SCIT administration. Proportions were compared between study arms. The tolerability of SCIT was evaluated by early and late local reactions (i.e., local swelling and redness) and systemic reactions after each injection (any symptoms from organs distant from the location of the injection). Reactions were classified depending on the severity and onset of the reaction, according to the EAACI classification (Alvarez-Cuesta 2006).
Time frame: From informed consent signature (V0) until the end of patient participation in the study (depending on the treatment assigned between 4 and 8 weeks )
Immunoglobulin Levels (IgE Specific) Active Versus Placebo
Changes on immunoglobulin level determinations (specific IgE, IgG and IgG4) from basal visit to final visit and changes in mean wheal area in prick test dose response from basal visit to final visit, active versus placebo.
Time frame: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
Immunoglobulin Levels (IgG Total) Active Versus Placebo
Changes on immunoglobulin level determinations (IgG) from basal visit to final visit and changes in mean wheal area in prick test dose response from basal visit to final visit, active versus placebo.
Time frame: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
Immunoglobulin Levels (IgG 4) Active Versus Placebo
Changes on immunoglobulin level determinations (IgG4) from basal visit to final visit and changes in mean wheal area in prick test dose response from basal visit to final visit, active versus placebo.
Time frame: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
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