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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Rhinitis, Allergic
- Sponsor
- Roxall Medicina España S.A
- Enrollment
- 122
- Locations
- 10
- Primary Endpoint
- Combined Symptoms and Medication Score (CSMS)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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).
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Combined Symptoms and Medication Score (CSMS)
Time Frame: Basal-12 months
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
Secondary Outcomes
- Patient´s Tolerability assessment using a Likert-type scale(6 months-12 months)
- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)(Basal-12 months)
- Total number, percentage, severity and gradation of adverse reactions(Basal- 6 months-12 months)
- Patient's perception of the improvement in their global status using a Likert-type scale(12 months)
- Patient's Satisfaction using a Likert scale(12 months)