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

Rhinoconjunctivitis Clinical Trial

— ARES  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03821077
• Other study ID #: ROX-ALE-2018-01
• Status: Completed
• Start date: August 30, 2018
• Est. completion date: September 13, 2021

Study information

• Verified date: October 2021
• Source: Roxall Medicina España S.A
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: September 13, 2021
• Est. primary completion date: September 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Conjunctivitis
• Rhinitis
• Rhinitis, Allergic
• Rhinoconjunctivitis

Intervention

Biological:
• Allergen Immunotherapy (AIT)
Immunotherapy vaccine with 2 allergenic extracts mixtures (pollens or mites)in polimerized-depot formulation

Locations

Country	Name	City	State
Spain	Allercen	Barcelona
Spain	Centre Medic Catalonia	Barcelona
Spain	Hospital QuironSalud Barcelona	Barcelona
Spain	Hospital Sanitas CIMA	Barcelona
Spain	Fundación Hospital Calahorra	Calahorra	La Rioja
Spain	Centre Assistencial Baix Llobregat	Cornellà De Llobregat	Barcelona
Spain	Hospital de Igualada	Igualada	Barcelona
Spain	CAR SAn Millán	Logroño	La Rioja
Spain	Centro médico Promosalud	Logroño	La Rioja
Spain	GAME Centre Medic	Sant Boi De Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Roxall Medicina España S.A

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	Basal-12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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