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

Sponsor

Roxall Medicina España S.A (Industry)

Overall Status

Completed

CT.gov ID

NCT03821077

Collaborator

(none)

122

Enrollment

Locations

36.5

Actual Duration (Months)

12.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Rhinitis, Allergic Rhinoconjunctivitis	Biological: Allergen Immunotherapy (AIT)

Study Design

Study Type:

Observational

Actual Enrollment :

122 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 30, 2018

Actual Primary Completion Date :

Sep 13, 2021

Actual Study Completion Date :

Sep 13, 2021

Outcome Measures

Primary Outcome Measures

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

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 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)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Centre Assistencial Baix Llobregat	Cornellà De Llobregat	Barcelona	Spain
2	Hospital de Igualada	Igualada	Barcelona	Spain
3	GAME Centre Medic	Sant Boi De Llobregat	Barcelona	Spain
4	Fundación Hospital Calahorra	Calahorra	La Rioja	Spain
5	CAR SAn Millán	Logroño	La Rioja	Spain
6	Centro médico Promosalud	Logroño	La Rioja	Spain
7	Allercen	Barcelona		Spain
8	Centre Medic Catalonia	Barcelona		Spain
9	Hospital QuironSalud Barcelona	Barcelona		Spain
10	Hospital Sanitas CIMA	Barcelona		Spain