Allergic rhinitis/ rhinoconjuntivitis associated or not with asthma MedDRA version: 21.1 Level: LLT Classification code 10001724 Term: Allergic rhinitis (excl hay fever) System Organ Class: 100000004855
Conditions
Interventions
Product Name: Beltavac® with polymerized extract from Dermatophagoides
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: House dust mites allergoid from Dermatophagoides pteronyssinus
Sponsors
Probelte Pharma S.L.U.
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? yes Number of subjects for this age range: 77 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 273 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of Beltavac® with polymerized dust mite extract measured by the combined scale of nasal symptoms and specific allergy medication completed by the patient daily in periods of 4 weeks repeatedly for a year.;Secondary Objective: To assess the efficacy of of Beltavac® with polymerized dust mite extract measured by the impact on: -the combined scale of nasal and ocular symptoms and specific allergy medication completed by the patient daily in periods of 4 weeks repeatedly for a year. - the global allergy symptoms, rhinitis control and quality of life at baseline and after 6 and 12 months of treatment. - serological levels of specific antibodies at baseline and after 6 and 12 months of treatment. To assess the safety of of Beltavac® with polymerized dust mite extract measured during the study period. To assess the impact of IMP on health economics during the study period.;Primary end point(s): The primary endpoint is the combined nasal symptom and medication score. The symptoms assessed are: itchy nose, sneezing, runny nose, and blocked nose (all rated from 0-3). The medication score is 1 for oral and/or topical antihistamines, 2 for intranasal corticosteroids, and 3 for oral corticosteroids. The scores from the nasal symptoms are added and divided by 4 to a total daily symptom score from 0-3. The total daily medication score ranges from 0-3. The combined nasal symptom and medication score will range from 0-6.;Timepoint(s) of evaluation of this end point: Four weeks before randomization visit and at 6, 9 and 12 months of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Score of the nasal symptoms scale. -Score of the specific medication scale. -Nasal and ocular symptom scale score -Score of the combined scale of nasal, ocular symptoms and medication. -Percentage of days without symptoms or medication. -VAS score (completed by the patient and the investigator) and RCAT and mini-RQLQ questionnaires. -Specific values in serum of IgE and IgG4 specific to DPT and total DF, Der p1 and Der p2, Der p23, Der f1, Der f2 . -Number of local and systemic reactions. -Biochemical and hematological parameters. -Number of days of hospitalization, number of visits to the emergency room, family doctor, specialist, ICU admission, number of absences from work / school and medication.;Timepoint(s) of evaluation of this end point: Symptoms and medication score will be performed four weeks before randomization visit and at 6, 9 and 12 months of treatment. The rest of the efficacy endpoints will be assessed at baseline and after 6 and 12 months of treatment. Biochemical and hematological parameters will be measured at baseline and end of the study. The rest the safety and health economics endpoints will be recorded during the whole study period. | — |
Countries
Spain
Contacts
Public ContactMedical Affairs
Probelte Pharma
Outcome results
None listed