Evaluation of Tolerability and Safety of "Allergovac Poliplus" in Polysensitized Patients With Rhinitis or Allergic Rhinoconjunctivitis With or Without Asthma: A Study in Daily Clinical Practice

NCT ID: NCT02844842

Last Updated: 2019-01-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 152 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-23
• Study Completion Date: 2018-09-06

Brief Summary

This is an observational prospective study to assess the tolerability and safety of treatment of SCIT Allergovac Poliplus polymerized in depot presentation. The study drug will be administered either by a 1 day Schedule or by a rapid Schedule (3 increasing weekly doses at initiation period till maintenance dose is reached) The study population is both: adult and child, polysensitized to at least 2 allergen sources with rhinitis or allergic rhinoconjunctivitis. Patients may also present a concomitant mild or moderate asthma.

The assignment of a patient to a particular therapeutic strategy will not be decided in advanced by a trial protocol but will be determined by routine clinical practice. The decision of the investigator to prescribe a particular treatment will be clearly dissociated from the decision to include the patient in the study. The patients will not suffer any intervention, whether diagnostic or monitoring, other than the usual in clinical practice.

Conditions

Allergic Rhinitis; Rhinoconjunctivitis; Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1 day initiation schedule

The initiation Schedule consists in administering 0.2 mL and 0.3 mL with 30 minutes of interval in the same day. Thus, the patient will reach the maintenance dose of 0.5 mL in one day.

Allergovac Poliplus

Intervention Type: BIOLOGICAL

Rapid initiation schedule

The patient will receive 3 increasing doses (0.1 mL + 0.3mL + 0.5 mL) weekly doses till the maintenance dose (0.5 mL) is reached.

Allergovac Poliplus

Intervention Type: BIOLOGICAL

Interventions

Allergovac Poliplus

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Patients aged between 5 and 60 years who present rhinitis or allergic rhinoconjunctivitis caused by IgE-mediated sensitization to more than one allergen source with or without mild / moderate asthma.

2. Patients eligible for immunotherapy treatment with Allergovac Poliplus according to investigator criteria.

3. Patients must provide written informed consent. It is the case of children , the legal representative or tutor of the child must sign the inform consent form.

Exclusion Criteria

1. Patients that according to the investigator criteria may present difficulties for understanding the patient information sheet, completing the questionnaires and self-administered scales.

2. Patients that according to the investigator may present difficulties to complete the patient diary.

3. Patients who are participating in another clinical trial or observational study.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roxall Medicina España S.A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

C.H.U A Coruña

A Coruña, , Spain

Hopsital de Vinalopó

Elche, , Spain

Clínica Dr. Arias Irigoyen

Huelva, , Spain

Clínica Dra. Victoria Moreno

Huelva, , Spain

Hospital de Lugo

Lugo, , Spain

Clínica de Asma y Alergia Dres. Ojeda

Madrid, , Spain

Hospital Principe de Asturias

Madrid, , Spain

Hospital Puerta de Hierro

Madrid, , Spain

Hospital de Onteniente

Ontinyent, , Spain

Hospital de Tórax

Santa Cruz de Tenerife, , Spain

Hospital Ntra. Sra de la Candelaria

Santa Cruz de Tenerife, , Spain

Hospital Joan XXIII

Tarragona, , Spain

Hospital de Terrassa

Terrassa, , Spain

Hospital de Manises

Valencia, , Spain

Hospital de Xátiva

Xátiva, , Spain

Countries

Spain

Other Identifiers

BIA-ALE-2016-01

Identifier Type: -

Identifier Source: org_study_id