Clinical trial NCT03604718: Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Alternaria Alternata
Official title: Observational Prospective Study to Assess the Safety and Effectiveness Profile of Beltavac® Polymerized With Alternaria Alternata
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinoconjunctivitis With or Without Allergic Asthma
Lead sponsor: Probelte Pharma S.L.U.
Sponsor class: INDUSTRY
First posted: 2018-07-27
Enrollment: 65
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the age of 5 on, who suffer from allergic rhinoconjunctivitis caused by Alternaria alternata

Brief summary: Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerized With Alternaria alternata in allergic patients

Detailed description: This prospective open multi-centre non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac® Polymerized in Alternaria alternata allergic patients (children and adults) in routine medical care.

Patients receive a rush schedule administration every month for a year. They attend at least 4 study visits to inform about the adverse reactions, the self reported symptoms and the medication intake.

Eligibility criteria: Inclusion Criteria:

* Patients of the age of 5 years and older suffering from a clinically relevant Alternaria alternata induced allergic rhinitis
* Positive skin testing or IgE determination to the relevant allergen

Exclusion Criteria:

Patients suffering from acute or chronic infections or inflammations Patients suffering from uncontrolled asthma Patients with a known autoimmune disease Patients with active malignant disease Patients requiring beta-blockers Patients having any contraindication for the use of adrenaline

Primary outcomes:
measure: Numbers of treatment-related local and systemic reactions
timeFrame: 1 year
Secondary outcomes:
measure: Rhinoconjuntivitis medication intake
timeFrame: 1 year
measure: Visual analogue Scale Score
timeFrame: 1 year
measure: IgE and IgG4 specific quantification
timeFrame: 1 year
Other outcomes:
Locations:
city: Vic
country: Spain
facility: Universitary Hospital of Vic
state: Barcelona
city: Barcelona
country: Spain
facility: Medical Center Fedear
state: Cataluña
city: Torrejón De Ardoz
country: Spain
facility: University Hospital of Torrejon
state: Madrid
city: Cartagena
country: Spain
facility: University Hospital of Cartagena
state: Murcia
city: Talavera De La Reina
country: Spain
facility: Clínica de Alergia Mar Jiménez Lara
state: Toledo
city: Barcelona
country: Spain
facility: Allergo Centre
city: Barcelona
country: Spain
facility: Medical Center Cenvi Medic
city: Madrid
country: Spain
facility: Alergomundo
city: Madrid
country: Spain
facility: Clinica Torrelodones
city: Madrid
country: Spain
facility: Ojeda Clinic
city: Murcia
country: Spain
facility: University Hospital Virgen de la Arrixaca
city: Murcia
country: Spain
facility: Reina Sofia Universitary Hospital
city: Toledo
country: Spain
facility: Clinica Alergologica Dr Moral
Study officials:
affiliation: Probelte Pharma
name: Inmaculada Buendía Jiménez
role: STUDY_DIRECTOR
References: