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An Open Trial to Assess the Tolerability of AVANZ Olive Immunotherapy

NCT01674595 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2013-04-30

No results posted yet for this study

Summary

This trial is an open, national, multi-centre trial. The trial will be initiated after olive pollen season 2012 and subjects will receive treatment for 6 weeks.

The aim of study is to assess the tolerability of the up-dosing phase of AVANZ Olive. The frequency of patients with adverse reactions will be the primary endpoint.

Frequency of patients with systemic reactions according to EAACI classification, increase in IgG4 and in IgE and reduction in immediate skin reactivity.

Conditions

  • Allergic Rhinitis Due to Olea Europaea Pollen

Interventions

BIOLOGICAL

AVANZ olea

Immunotherapy Olea europaea

Sponsors & Collaborators

  • ALK-Abelló A/S

    lead INDUSTRY

Principal Investigators

  • CARMEN MORENO, MD · HOSPITAL UNIVERSITARIO REINA SOFÍA Córdoba- Spain

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Spain

Study Locations

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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 NCT01674595 on ClinicalTrials.gov