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

Asthma Clinical Trial

— APOLO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02844842
• Other study ID #: BIA-ALE-2016-01
• Status: Completed
• Start date: November 23, 2016
• Est. completion date: September 6, 2018

Study information

• Verified date: January 2019
• Source: Roxall Medicina España S.A
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: September 6, 2018
• Est. primary completion date: September 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• Conjunctivitis
• Conjunctivitis, Allergic
• Rhinitis
• Rhinitis, Allergic
• Rhinoconjunctivitis

Intervention

Biological:
• Allergovac Poliplus

Locations

Country	Name	City	State
Spain	C.H.U A Coruña	A Coruna
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	Onteniente
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

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	Number and severity of adverse drug reactions		From patient ICF signature till 1 week after last administered dose