Study to Evaluate the Efficacy and Safety of "Allergovac Poliplus" in Polysensitized Patients With Allergic Rhinitis/Rhinoconjunctivitis, With or Without Asthma (ARES)

ROXALL

Status: Completed

Conditions: Rhinoconjunctivitis; Rhinitis, Allergic

Treatments: Biological: Allergen Immunotherapy (AIT)

Study type: Observational

Funder types: Industry

Identifiers

NCT03821077

ROX-ALE-2018-01

Details and patient eligibility

About

This is an observational prospective multicenter clinical study, to evaluate the efficacy and safety of the treatment with Allergovac Poliplus subcutaneous immunotherapy (SCIT) with a mixture of 2 allergenic extracts (pollens or mites), in polymerized-depot formulation, administered in its different available allergenic extracts mixtures (2 pollens or 2 mites), and in one of the 2 recommended administration schedules (1 Day or Rapid).

Enrollment: 122 patients

Sex: All

Ages: 5 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged between 5 and 60 years with allergic rhinitis or rhinoconjunctivitis mediated by IgE, caused by sensitization to more than one allergenic source (pollens or mites) and with or without associated mild / moderate asthma.
2. Patients susceptible to receive treatment with Allergovac Poliplus (SCIT), according to usual clinical practice
3. Patients who have given their signed informed consent.

Exclusion criteria

1. Patients who have received or initiated treatment with Allergovac Poliplus previously to study inclusion.
2. Patients who have received previous immunotherapy treatment, both subcutaneous (SCIT) and sublingual (SLIT), with any of the allergenic extracts that they plan to receive, in the 5 years prior to study inclusion.
3. Patients who in the opinion of the investigator may present difficulties that prevent the understanding of what was written in the informed consent form or the completion of self-administered questionnaires / scales or the patient's diary.
4. Patients who are participating in another clinical trial or observational study with any drug.