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 (APOLO)

January 24, 2019 updated by: Roxall Medicina España S.A

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

152

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruna, Spain
        • C.H.U A Coruña
      • Elche, Spain
        • Hopsital de Vinalopó
      • Huelva, Spain
        • Clínica Dr. Arias Irigoyen
      • Huelva, Spain
        • Clínica Dra. Victoria Moreno
      • Lugo, Spain
        • Hospital de Lugo
      • Madrid, Spain
        • Hospital Puerta de Hierro
      • Madrid, Spain
        • Hospital Príncipe de Asturias
      • Madrid, Spain
        • Clínica de Asma y Alergia Dres. Ojeda
      • Onteniente, Spain
        • Hospital de Onteniente
      • Santa Cruz de Tenerife, Spain
        • Hospital de Tórax
      • Santa Cruz de Tenerife, Spain
        • Hospital Ntra. Sra de la Candelaria
      • Tarragona, Spain
        • Hospital Joan XXIII
      • Terrassa, Spain
        • Hospital de Terrassa
      • Valencia, Spain
        • Hospital de Manises
      • Xátiva, Spain
        • Hospital de Xativa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 56 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Polisensitized patients with allergic rinitis and rhinoconjunctivitis with or without associated mild or moderate asthma

Description

Inclusion Criteria:

  1. Patients aged between 5 and 60 years who present rhinitis or allergic rhinoconjunctivitis caused by IgE-mediated sensitization to more than one allergen source with or without mild / moderate asthma.
  2. Patients eligible for immunotherapy treatment with Allergovac Poliplus according to investigator criteria.
  3. Patients must provide written informed consent. It is the case of children , the legal representative or tutor of the child must sign the inform consent form.

Exclusion Criteria:

  1. Patients that according to the investigator criteria may present difficulties for understanding the patient information sheet, completing the questionnaires and self-administered scales.
  2. Patients that according to the investigator may present difficulties to complete the patient diary.
  3. Patients who are participating in another clinical trial or observational study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1 day initiation schedule
The initiation Schedule consists in administering 0.2 mL and 0.3 mL with 30 minutes of interval in the same day. Thus, the patient will reach the maintenance dose of 0.5 mL in one day.
Biological: Allergovac Poliplus
Rapid initiation schedule
The patient will receive 3 increasing doses (0.1 mL + 0.3mL + 0.5 mL) weekly doses till the maintenance dose (0.5 mL) is reached.
Biological: Allergovac Poliplus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number and severity of adverse drug reactions
Time Frame: From patient ICF signature till 1 week after last administered dose
From patient ICF signature till 1 week after last administered dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roxall Medicina España S.A

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 23, 2016

Primary Completion (Actual)

September 6, 2018

Study Completion (Actual)

September 6, 2018

Study Registration Dates

First Submitted

July 22, 2016

First Submitted That Met QC Criteria

July 25, 2016

First Posted (Estimate)

July 26, 2016

Study Record Updates

Last Update Posted (Actual)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 24, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIA-ALE-2016-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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