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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Allergic Rhinitis, Rhinoconjunctivitis, Asthma

Intervention / Treatment
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* Biological: Allergovac Poliplus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Patients eligible for immunotherapy treatment with Allergovac Poliplus according to investigator criteria. 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: Patients that according to the investigator criteria may present difficulties for understanding the patient information sheet, completing the questionnaires and self-administered scales. Patients that according to the investigator may present difficulties to complete the patient diary. Patients who are participating in another clinical trial or observational study.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1 day initiation schedule<br>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<br> <br> |
| Rapid initiation schedule<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild or moderate