Allergic Rhinoconjunctivitis Clinical Trial
Official title:
Phase II, Multicenter, Randomized, Double Blind Study, With Subcutaneous Immunotherapy At Different Doses, in Parallel Groups and Placebo-Controlled, in Patients With Rhinoconjunctivitis ± Asthma Sensitized to Phleum Pratense
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 is to establish a dose-response relationship for clinical efficacy of Phleum pratense pollen extract subcutaneous vaccine.
In adherence to EMA guidelines, the Phase I Clinical trial was carried out using Phleum
pratense extract in depot presentation using 3 different dose escalation scheme. The
objective was to compare tolerance and safety of the three dose escalation scheme as well as
to determine the maximum dose tolerated by the population.
Once the range of tolerated doses was established, and following the strict norms of the EMA,
a Phase II dose response clinical trial was designed wherein the efficacy of subcutaneous
immunotherapy in depot presentation could be compared in 5 different doses. One of these
doses will be the MTD established by the population in the first study, another will be lower
than this dose, and three will be greater than it. The dose escalation scheme to be tested
was chosen based on the results of the aforementioned clinical trial. As dictated by EMA
norms, a control placebo will be used.
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