Clinical trial NCT02844842: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Rhinoconjunctivitis
Asthma
Keywords: mild or moderate
Lead sponsor: Roxall Medicina España S.A
Sponsor class: INDUSTRY
First posted: 2016-07-26
Enrollment: 152
Sex: ALL
Minimum age (years): 5
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Polisensitized patients with allergic rinitis and rhinoconjunctivitis with or without associated mild or moderate asthma

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.


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.

Primary outcomes:
measure: Number and severity of adverse drug reactions
timeFrame: From patient ICF signature till 1 week after last administered dose
Secondary outcomes:
Other outcomes:
Locations:
city: A Coruna
country: Spain
facility: C.H.U A Coruña
city: Elche
country: Spain
facility: Hopsital de Vinalopó
city: Huelva
country: Spain
facility: Clínica Dr. Arias Irigoyen
city: Huelva
country: Spain
facility: Clínica Dra. Victoria Moreno
city: Lugo
country: Spain
facility: Hospital de Lugo
city: Madrid
country: Spain
facility: Clínica de Asma y Alergia Dres. Ojeda
city: Madrid
country: Spain
facility: Hospital Principe de Asturias
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Onteniente
country: Spain
facility: Hospital de Onteniente
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital de Tórax
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Ntra. Sra de la Candelaria
city: Tarragona
country: Spain
facility: Hospital Joan XXIII
city: Terrassa
country: Spain
facility: Hospital de Terrassa
city: Valencia
country: Spain
facility: Hospital de Manises
city: Xátiva
country: Spain
facility: Hospital de Xátiva
Study officials:
References: