MedTrace Logo

A Trial With Subcutaneous Immunotherapy (SCIT) in Patients With Rhinoconjunctivitis Sensitized to Olea Europaea and Phleum Pratense

NCT02849249 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2017-05-01

No results posted yet for this study

Summary

The study was designed according to the draft of allergenic product regulation published by Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with polimerized (100/100) mixture of pollens: Olea europaea and Phleum pratense in patients with rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.

Conditions

  • Rhinoconjuntivitis

Interventions

BIOLOGICAL

allergovac polimerized (100/100)

Patients will recieve a initiation phase plus a mantenaince phase for 3 months of an allergy vaccine.

Sponsors & Collaborators

  • Roxall Medicina España S.A

    lead INDUSTRY

Principal Investigators

  • María C Gómez, Dr. · Roxall Medicina España S.A

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02849249 on ClinicalTrials.gov