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)

ROXALL

Status: Completed

Conditions: Asthma; Rhinoconjunctivitis; Allergic Rhinitis

Treatments: Biological: Allergovac Poliplus

Study type: Observational

Funder types: Industry

Identifiers

NCT02844842

BIA-ALE-2016-01

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: All

Ages: 5 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

152 participants in 2 patient groups

1 day initiation schedule

Description:

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.

Treatment:

Biological: Allergovac Poliplus

Rapid initiation schedule

Description:

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.

Treatment:

Biological: Allergovac Poliplus