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

Last updated: January 24, 2019
Sponsor: Roxall Medicina España S.A
Overall Status: Completed

Phase

N/A

Condition

Allergy

Eye Disorders/infections

Acute Rhinitis

Treatment

N/A

Clinical Study ID

NCT02844842
BIA-ALE-2016-01
  • Ages 5-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients aged between 5 and 60 years who present rhinitis or allergicrhinoconjunctivitis caused by IgE-mediated sensitization to more than one allergensource with or without mild / moderate asthma.

  2. Patients eligible for immunotherapy treatment with Allergovac Poliplus according toinvestigator criteria.

  3. Patients must provide written informed consent. It is the case of children , the legalrepresentative or tutor of the child must sign the inform consent form.

Exclusion

Exclusion Criteria:

  1. Patients that according to the investigator criteria may present difficulties forunderstanding the patient information sheet, completing the questionnaires andself-administered scales.

  2. Patients that according to the investigator may present difficulties to complete thepatient diary.

  3. Patients who are participating in another clinical trial or observational study.

Study Design

Total Participants: 152
Study Start date:
November 23, 2016
Estimated Completion Date:
September 06, 2018

Connect with a study center

  • C.H.U A Coruña

    A Coruna,
    Spain

    Site Not Available

  • Hospital Vall d'Hebron

    Barcelona,
    Spain

    Site Not Available

  • Hopsital de Vinalopó

    Elche,
    Spain

    Site Not Available

  • Clínica Dr. Arias Irigoyen

    Huelva,
    Spain

    Site Not Available

  • Clínica Dra. Victoria Moreno

    Huelva,
    Spain

    Site Not Available

  • Hospital de Lugo

    Lugo,
    Spain

    Site Not Available

  • Clínica de Asma y Alergia Dres. Ojeda

    Madrid,
    Spain

    Site Not Available

  • Hospital Principe de Asturias

    Madrid,
    Spain

    Site Not Available

  • Hospital Puerta de Hierro

    Madrid,
    Spain

    Site Not Available

  • Hospital de Onteniente

    Onteniente,
    Spain

    Site Not Available

  • Hospital Ntra. Sra de la Candelaria

    Santa Cruz de Tenerife,
    Spain

    Site Not Available

  • Hospital de Tórax

    Santa Cruz de Tenerife,
    Spain

    Site Not Available

  • Hospital Joan XXIII

    Tarragona,
    Spain

    Site Not Available

  • Hospital de Terrassa

    Terrassa,
    Spain

    Site Not Available

  • Hospital de Manises

    Valencia,
    Spain

    Site Not Available

  • Hospital de Xátiva

    Xátiva,
    Spain

    Site Not Available

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