Clinical trial NCT05395689: Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM
Official title: Efficacy and Safety Assessment of a Subcutaneous Immunotherapy (Beltavac®) With Polymerized Allergenic Extract From House Dust Mites in Patients With Allergic Rhinitis/Rhinoconjuntivitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: House Dust Mite Allergy
Lead sponsor: Probelte Pharma S.L.U.
Sponsor class: INDUSTRY
First posted: 2022-05-27
Enrollment: 350
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial is performed to assess efficacy and safety of Beltavac with polymerized extract of house dust mites in allergic Rhinoconjunctivitis associated or not with asthma


Eligibility criteria: Inclusion Criteria:

* Written informed consent, signed and duly dated.
* Man or woman between 12 and 65 years old (both included).
* Patient with moderate or severe symptoms of persistent rhinitis according to the ARIA Guide, associated or not with well or partially controlled asthma according to the GEMA 5.0 Guide.
* Confirmation of sensitization to DPT or DF with a positive prick test (mean papule diameter greater than or equal to 3 mm) with a commercial standardized allergenic extract and a serum extract-specific IgE value of class 3 or higher (\> 3.5 kU / L) within the 6 months prior to the study.
* Negative pregnancy test.
* Nasal symptom and medication combined scale score ≥ 1.5 during the screening phase.

Exclusion Criteria:

* Concomitant sensitization to allergens other than dust mites if clinically relevant symptoms are anticipated that may interfere with study evaluation periods at the discretion of the investigator.
* Poorly controlled asthma according to the GEMA 5.0 guideline
* Severe asthma, that is, those who during the last months have controlled their asthma according to therapeutic step 5-6 of the GEMA 5.0 guideline.
* Autoimmune diseases or immunodeficiency.
* Malignant neoplasms, serious cardiovascular disease, serious mental illness or other relevant chronic diseases that may interfere with the results of the study.
* Clinical history of anaphylaxis with cardio / respiratory symptoms.
* Hypersensitivity to any of the excipients of the investigational product.
* Immunosuppressive medication during the last 6 months before the inclusion of patients and until the end of the study.
* Treatment with beta-blockers during the study.
* Patients who have previously received immunotherapy with allergenic dust mite extract or other extracts and have failed within the last 5 years.
* Patients with immunotherapy with allergens other than dust mites during the study period.
* Patients who receive any other vaccine one week before the start of treatment or awaiting the second dose of vaccine against COVID-19.
* Pregnant or nursing patients.

Primary outcomes:
measure: The combined nasal symptom and medication score
timeFrame: 12 months of treatment
Secondary outcomes:
measure: Score of the nasal symptoms scale
timeFrame: 12 months of treatment
measure: Score of the specific medication scale
timeFrame: 12 months of treatment.
measure: Percentage of days without symptoms or medication
timeFrame: 12 months of treatment
measure: VAS score (completed by the patient and the investigator)
timeFrame: 12 months of treatment.
measure: RCAT questionnaire
timeFrame: 12 months of treatment.
measure: Mini-RQLQ questionnaires
timeFrame: 12 months of treatment.
measure: Values in serum of specific IgE and IgG4
timeFrame: 12 months of treatment.
measure: Number of local and systemic reactions.
timeFrame: 13 months of study follow up
measure: Cost-effectiveness analysis
timeFrame: 13 months of study follow up
measure: The combined asthma symptom and medication score
timeFrame: 12 months of treatment
measure: PEF
timeFrame: 12 months of treatment
measure: ACT questionnaire
timeFrame: 12 months of treatment
Other outcomes:
Locations:
city: Orihuela
country: Spain
facility: Hospital Vega Baja
state: Alicante
city: Granollers
country: Spain
facility: Hospital General de Granollers
state: Barcelona
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital de Canarias
state: Canarias
city: Castellón De La Plana
country: Spain
facility: Hospital de la Plana
state: Castellón
city: Malaga
country: Spain
facility: Hospital Regional de Málaga
state: Málaga
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Fundacion Sanitaria Sant Pere Claver
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital infantil Vall d Hebron
city: Barcelona
country: Spain
facility: Hospital Val d ' Hebron
city: Castelló
country: Spain
facility: Hospital General de Castellón
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Sevilla
country: Spain
facility: Hospital de Fatima
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Politecnico de la Fé
city: Valencia
country: Spain
facility: Hospital Universitario Infantil de la Fé
Study officials:
References: