Clinical trial NCT04207697: Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Cat Dander
Official title: Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Cat Dander
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: 2019-12-23
Enrollment: 34
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 12 years or older who suffer from allergic rhinoconjunctivitis caused by cat dander

Brief summary: Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerized With Cat Dander 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 with cat dander allergic patients (children and adults) in routine medical care. Patients receive a rush schedule administration every month for a year. They attend at least 5 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 12 years and older suffering from a clinically relevant cat dander induced allergic rhinitis or rhinoconjunctivitis associated with or not with asthma
* Positive skin testing
* Positive Serum-Specific IgE determination
* Informed consent

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
* Patients with previous immunotherapy with this allergen or another allergen with cross-reaction
* Patients with immunotherapy treatment at the time of inclusion

Primary outcomes:
measure: Numbers of treatment-related local and systemic reactions
timeFrame: 12 months
Secondary outcomes:
measure: Combined Symptom and Medication Score of Rhinoconjunctivitis
timeFrame: 12 months
measure: Combined Symptom and Medication Score of Asthma
timeFrame: 12 months
measure: Visual analogue Scale Score
timeFrame: 12 months
measure: IgE and IgG4 specific quantification
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Campus de la Salud University Hospital
state: Andalucía
city: Jaén
country: Spain
facility: Ciudad de Jaen Hospital
state: Andalucía
city: Palmones
country: Spain
facility: Quirón Campo de Gibraltar Hospital
state: Cádiz
city: Málaga
country: Spain
facility: Quirón Malaga Hospital
state: Malaga
city: Barcelona
country: Spain
facility: Al-lergo Centre Clinic
city: Barcelona
country: Spain
facility: Bellvitge University Hospital
city: Granada
country: Spain
facility: Alergogranada
Study officials:
affiliation: San Cecilio Universitary Hospital
name: Carolina Mérida
role: PRINCIPAL_INVESTIGATOR
References: