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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
151
Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Increasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Increasing dosages till the maintenance dose of 1SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Hospital da Universidade de Coimbra
Coimbra, Portugal
Centro Hospitalar de S. João
Porto, Portugal
Instituto CUF Porto
Senhora da Hora, Portugal
Centro Hospitalar de Setúbal - Hospital de São Bernardo
Variation of the Concentration of Phleum Pratense Extract Needed to Produce a Positive Nasal Provocation Test From Baseline (V0) to Final Visit (FV).
Variation of the concentration of Phleum pratense 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: Baseline (V0) and Final Visit (FV). The Final Visit will be conducted within 7 plus minus 2 days after the last dose is administered. The study will be carried out outside the pollination season of Phleum pratense.
All Adverse Reactions and or Events Will be Recorded Both by the Patient and the Health Care Personnel Responsible for the Administration of the Subcutaneous Immunotherapy.
All adverse reactions and/or events were recorded both by the patient and the health care personnel responsible for the administration of the subcutaneous immunotherapy. The incidence and intensity of adverse events was compared among the treatment groups.
Time frame: From baseline (V0) to final visit (VF). The Final Visit will be conducted within 7 plus minus 2 days after the last dose is administered. All AE should be monitored until they are satisfactorily resolved or stabilized after the final visit of the study
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Increasing dosages till the maintenance dose of 2 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Increasing dosages till the maintenance dose of 4SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Increasing volumes of placebo. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Setúbal, Portugal
Centro Hospitalar Gaia/Espinho
Vila Nova de Gaia, Portugal
Hospital Ntra. Sra. del Prado
Talavera de la Reina, Toledo, Spain
Hospital Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Puerta de Hierro
Madrid, Spain