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
APOLO
1 other identifier
observational
152
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2016
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2016
CompletedFirst Posted
Study publicly available on registry
July 26, 2016
CompletedStudy Start
First participant enrolled
November 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2018
CompletedJanuary 25, 2019
January 1, 2019
1.8 years
July 22, 2016
January 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number and severity of adverse drug reactions
From patient ICF signature till 1 week after last administered dose
Study Arms (2)
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.
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.
Interventions
Eligibility Criteria
Polisensitized patients with allergic rinitis and rhinoconjunctivitis with or without associated mild or moderate asthma
You may qualify if:
- 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.
- Patients eligible for immunotherapy treatment with Allergovac Poliplus according to investigator criteria.
- 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.
You may not qualify if:
- Patients that according to the investigator criteria may present difficulties for understanding the patient information sheet, completing the questionnaires and self-administered scales.
- Patients that according to the investigator may present difficulties to complete the patient diary.
- Patients who are participating in another clinical trial or observational study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2016
First Posted
July 26, 2016
Study Start
November 23, 2016
Primary Completion
September 6, 2018
Study Completion
September 6, 2018
Last Updated
January 25, 2019
Record last verified: 2019-01