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

Completed

• Conditions: Rhinitis, Allergic; Rhinoconjunctivitis

• Registration Number: NCT03821077
• Lead Sponsor: Roxall Medicina España S.A

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-30
• Study First Submitted: 2019-01-24
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-29
• Primary Completion: 2021-09-13
• Study Completion: 2021-09-13
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-19
• Last Update Posted: 2021-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

1. 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.
2. Patients susceptible to receive treatment with Allergovac Poliplus (SCIT), according to usual clinical practice
3. Patients who have given their signed informed consent.

Exclusion Criteria

1. Patients who have received or initiated treatment with Allergovac Poliplus previously to study inclusion.
2. 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.
3. 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.
4. Patients who are participating in another clinical trial or observational study with any drug.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Combined Symptoms and Medication Score (CSMS)	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 Outcome Measures

Name	Time	Method
Patient´s Tolerability assessment using a Likert-type scale	6 months-12 months	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)
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)	Basal-12 months	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.
Total number, percentage, severity and gradation of adverse reactions	Basal- 6 months-12 months	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.
Patient's perception of the improvement in their global status using a Likert-type scale	12 months	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)
Patient's Satisfaction using a Likert scale	12 months	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)

Trial Locations

Locations (10)

Allercen; 🇪🇸 Barcelona, Spain

Centre Assistencial Baix Llobregat; 🇪🇸 Cornellà De Llobregat, Barcelona, Spain

Hospital de Igualada; 🇪🇸 Igualada, Barcelona, Spain

GAME Centre Medic; 🇪🇸 Sant Boi De Llobregat, Barcelona, Spain

Centre Medic Catalonia; 🇪🇸 Barcelona, Spain

Hospital QuironSalud Barcelona; 🇪🇸 Barcelona, Spain

Hospital Sanitas CIMA; 🇪🇸 Barcelona, Spain

CAR SAn Millán; 🇪🇸 Logroño, La Rioja, Spain

Centro médico Promosalud; 🇪🇸 Logroño, La Rioja, Spain

Fundación Hospital Calahorra; 🇪🇸 Calahorra, La Rioja, Spain