CompletedNot Applicable

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

Spain122 participantsStarted 2018-08-30

Plain-language summary

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).

Who can participate

Age range5 Years – 60 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Patients susceptible to receive treatment with Allergovac Poliplus (SCIT), according to usual clinical practice
✓. Patients who have given their signed informed consent.

Exclusion criteria

✕. Patients who have received or initiated treatment with Allergovac Poliplus previously to study inclusion.
✕. 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.
✕. 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.
✕. Patients who are participating in another clinical trial or observational study with any drug.

What they're measuring

Combined Symptoms and Medication Score (CSMS)

Timeframe: Basal-12 months

Trial details

NCT IDNCT03821077

SponsorRoxall Medicina España S.A

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-09-13

View on ClinicalTrials.gov More Rhinitis, Allergic trials