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

Study Overview
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Brief Summary
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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).

Official Title
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Prospective Observational Study to Evaluate the Efficacy and Safety of Treatment With Allergovac Poliplus in Polysensitized Patients With Allergic Rhinitis/Rhinoconjunctivitis, With or Without Associated Asthma

Conditions
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Rhinitis, Allergic, Rhinoconjunctivitis

Intervention / Treatment
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* Biological: Allergen Immunotherapy (AIT)


Participation Criteria
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Eligibility Criteria
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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.

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

| Intervention/Treatment |
| --- |
|Biological: Allergen Immunotherapy (AIT)|Immunotherapy vaccine with 2 allergenic extracts mixtures (pollens or mites)in polimerized-depot formulation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined Symptoms and Medication Score (CSMS) | The score ranged from 0 to 6 points and is obtained as follows: Symptoms Score (SS) (from 0 to 3 points) + Medication Score (MS) (from 0 to 3 points). Through these 2 sub-scales the total score of the Combined Symptom and Medication Scale (CSMS) is obtained as follows: CSMS = SS (0-3) + MS (0-3) = 0-6 points The 0 value indicate no symptoms and no medication, and 6 points indicate the worst state of symptoms and the highest medication step | Basal-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | The RQLQ has 28 questions in 7 domains (activity limitation, sleep problems, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems and emotional function). It is a self-administered questionnaire where patients respond to each question on a 7-point scale (0 = not impaired at all - 6 = severely impaired). The overall RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. Higher scores reflect lower quality of life. | Basal-12 months | 
| Total number, percentage, severity and gradation of adverse reactions | Total number, percentage, severity and gradation of adverse reactions reported (local and systemics), in relation to the total number of patients and the total administered doses, both globally and according to each administration schedule. | Basal- 6 months-12 months | 
| Patient´s Tolerability assessment using a Likert-type scale | Patient´s Tolerability assessment using a Likert-type scale, with a score of 1 to 4 points (from 1 = I have tolerated it very well to 4 = I have tolerated it very badly) | 6 months-12 months | 
| Patient's perception of the improvement in their global status using a Likert-type scale | Evaluation of the patient's perception of the improvement in the global state of the pathology, using a Likert-type scale, with a score of 1 to 4 points (from 1= good or excellent improvement to 4 = worsening) | 12 months | 
| Patient's Satisfaction using a Likert scale | Degree of patients' satisfaction with the treatment using a Likert scale, with a score of 1 to 4 points (from 1 = Very Satisfied to 4 = Very dissatisfied) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergen immunotherapy (AIT), Rhinitis, Rhinoconjunctivitis, Subcutaneous Immunotherapy (SCIT), Allergovac Poliplus