As part of the registration plan of our products and after performing a Phase I study the present trial has been designed to compare the efficacy of 5 different doses of subcutaneous immunotherapy in depot presentation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Depot sterile suspension fpor subcutaneous injection Increasing concentrations to reach the following maintenance doses: Group 1: 0.25 SPT
Depot sterile suspension for subcutaneous injection. Increasing concentrations to reach the following maintenance doses: Group 2: 0.5 SPT
Depot sterile suspension for subcutaneous injection. Increasing concentrations to reach the following maintenance doses: Group 3: 1 SPT
Hospital Vega Baja
Orihuela, Alicante, Spain
Hospital Germans Triasl i Pujol
Badalona, Barcelona, Spain
Hospital Donostia
Donostia / San Sebastian, Guipuzcoa, Spain
Changes in nasal provocation test
Variation of the concentration of DPT extract needed to produce a positive nasal provocation test from baseline (V0) to final visit (FV). The changes will be compared among groups (including the placebo group).
Time frame: from baseline (V0) to final visit (VF 18 weeks after randmization)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
depot sterile suspension for subcutaneous injection Increasing concentrations to reach the following maintenance doses: Group 4: 2 SPT
Depot sterile suspension for subcutaneous injection. Increasing concentrations to reach the following maintenance doses: Group 5: 4 SPT
Sterile suspension for subcutaneous injection. Same number of administration as the active groups
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña, Spain
Hospital Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Xeral de Vigo
Vigo, Pontevedra, Spain
Hospital de Manises
Manises, Valencia, Spain
Hospital Luis Alcañiz
Xátiva, Valencia, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
Hospital Blanca Paloma
Huelva, Spain
...and 2 more locations