NCT02844842

Evaluation of Tolerability and Safety of "Allergovac Poliplus" in Polysensitized Patients With Rhinitis or Allergic Rhinoconjunctivitis With or Without Asthma: A Study in Daily Clinical Practice

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 152 (actual)
• Sponsor: Roxall Medicina España S.A · Industry
• Sex: All
• Age: 5 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is an observational prospective study to assess the tolerability and safety of treatment of SCIT Allergovac Poliplus polymerized in depot presentation. The study drug will be administered either by a 1 day Schedule or by a rapid Schedule (3 increasing weekly doses at initiation period till maintenance dose is reached) The study population is both: adult and child, polysensitized to at least 2 allergen sources with rhinitis or allergic rhinoconjunctivitis. Patients may also present a concomitant mild or moderate asthma. The assignment of a patient to a particular therapeutic strategy will not be decided in advanced by a trial protocol but will be determined by routine clinical practice. The decision of the investigator to prescribe a particular treatment will be clearly dissociated from the decision to include the patient in the study. The patients will not suffer any intervention, whether diagnostic or monitoring, other than the usual in clinical practice.

Conditions

• Allergic Rhinitis
• Rhinoconjunctivitis
• Asthma

Interventions

Type	Name	Description
BIOLOGICAL	Allergovac Poliplus

Timeline

• Start date: 2016-11-23
• Primary completion: 2018-09-06
• Completion: 2018-09-06
• First posted: 2016-07-26
• Last updated: 2019-01-25

Locations

15 sites across 1 country: Spain