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

• ClinicalTrials.gov Identifier: NCT03821077
• Recruitment Status: Completed
• First Posted: January 29, 2019
• Last Update Posted: October 20, 2021
• Sponsor: Roxall Medicina España S.A
• Information provided by (Responsible Party): Roxall Medicina España S.A

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
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: August 30, 2018
• Actual Primary Completion Date: September 13, 2021
• Actual Study Completion Date: September 13, 2021

Groups and Cohorts

Intervention Details:

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

Outcome Measures

Primary Outcome Measures :

1. Combined Symptoms and Medication Score (CSMS) [ Time Frame: 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 :

1. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [ Time Frame: 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.
2. Total number, percentage, severity and gradation of adverse reactions [ Time Frame: 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.
3. Patient´s Tolerability assessment using a Likert-type scale [ Time Frame: 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)
4. Patient's perception of the improvement in their global status using a Likert-type scale [ Time Frame: 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)
5. Patient's Satisfaction using a Likert scale [ Time Frame: 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

• Ages Eligible for Study: 5 Years to 60 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients between 5-60 years, with allergic rhinitis/rhinoconjunctivitis with or without asthma, polisensitized to pollens/mites.

Criteria

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.

Contacts and Locations

Locations

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

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

Sponsors and Collaborators

Roxall Medicina España S.A

More Information

• Responsible Party: Roxall Medicina España S.A
• ClinicalTrials.gov Identifier: NCT03821077
• Other Study ID Numbers: ROX-ALE-2018-01
• First Posted: January 29, 2019
• Last Update Posted: October 20, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Roxall Medicina España S.A:

Allergen immunotherapy (AIT); Rhinitis; Rhinoconjunctivitis; Subcutaneous Immunotherapy (SCIT); Allergovac Poliplus

Additional relevant MeSH terms:

Rhinitis; Rhinitis, Allergic; Conjunctivitis; Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Conjunctival Diseases; Eye Diseases