An observational study in Rhinitis, Allergic and Rhinoconjunctivitis, sponsored by Roxall Medicina España S.A. Completed at 10 sites in Spain. Open to participants aged 5 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-10-20.
Sponsored by Roxall Medicina España S.A · Observational
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).
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 122 is below the median of 141 across 172 observational studies indexed under Rhinitis.
Browse Rhinitis studies →Roxall Medicina España S.A is the lead sponsor of 15 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients between 5-60 years, with allergic rhinitis/rhinoconjunctivitis with or without asthma, polisensitized to pollens/mites.
Exclusion Criteria:
Immunotherapy vaccine with 2 allergenic extracts mixtures (pollens or mites)in polimerized-depot formulation
Also known as: Allergovac Poliplus
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
Time frame: Basal-12 months
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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 12 months
Plan to share: No
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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Roxall Medicina España S.A