The primary objective of this study is to evaluate the safety and tolerance of a rush build up administration of Depigoid forte pollen and the first maintenance dose administered 4 weeks later.
The primary objective of this study is to evaluate the safety and tolerance of a rush build up administration of Depigoid forte pollen and the first maintenance dose administered 4 weeks later. The treatment period consists, thus, of 4 weeks. Primary variable: •Number of subjects \[%\] suffering at least one immediate or delayed systemic reaction of grade 2 or higher during the 4-weeks treatment period \[grading according to the 2006 EAACI standards
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
H. Manresa
Manresa, Barcelona, Spain
H. Virgen Macarena
Seville, Sevilla, Spain
H. Virgen del Rocío
Seville, Sevilla, Spain
H. Luis Alcañiz
Xàtiva, Valencia, Spain
immediate or delayed systemic reaction of grade 2 or higher during the treatment period
The primary variable in this study is the number of subjects \[%\] who experienced at least one immediate or delayed systemic reaction of grade 2 or higher during the treatment period.
Time frame: 4 weeks
immediate and/or delayed systemic reactions and immediate and/or delayed local reactions
Number of subjects \[%\] suffering immediate and/or delayed systemic reactions broken down by grade (EAACI classification). * Number of subjects \[%\] suffering immediate and/or delayed local reactions broken down by diameter (\< 5 cm, 5-10 cm or \> 10 cm). * Number of immediate and/or delayed systemic reactions broken down by grade (EAACI classification). * Number of immediate and/or delayed local reactions broken down by diameter (\< 5 cm, 5-10 cm and \> 10 cm). * (Immunology assessment):Measurement of the following immunological parameters: sIgE and sIgG4 at baseline and at the end of the study (after two maintenance doses).
Time frame: 4 weeks
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