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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allergen Immunotherapy (AIT) | Biological | Immunotherapy vaccine with 2 allergenic extracts mixtures (pollens or mites)in polimerized-depot formulation |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients between 5-60 years, with allergic rhinitis/rhinoconjunctivitis with or without asthma, polisensitized to pollens/mites.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Assistencial Baix Llobregat | Cornellà de Llobregat | Barcelona | Spain | |||
| Hospital de Igualada |
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| 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 |
| Igualada |
| Barcelona |
| Spain |
| GAME Centre Medic | Sant Boi de Llobregat | Barcelona | Spain |
| Fundación Hospital Calahorra | Calahorra | La Rioja | Spain |
| CAR SAn Millán | Logroño | La Rioja | Spain |
| Centro médico Promosalud | Logroño | La Rioja | Spain |
| Allercen | Barcelona | Spain |
| Centre Medic Catalonia | Barcelona | Spain |
| Hospital QuironSalud Barcelona | Barcelona | Spain |
| Hospital Sanitas CIMA | Barcelona | Spain |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003888 | Desensitization, Immunologic |
| ID | Term |
|---|---|
| D007165 | Immunosuppression Therapy |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
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