Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM
ConditionHouse Dust Mite Allergy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-65
SponsorProbelte Pharma S.L.U.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae
Biological/VaccineThe vaccine will be administered according to a rush schedule meaning one administration each month for 1 year
Placebo
Biological/VaccineThe vaccine will be administered according to a rush schedule meaning one administration each month for 1 year
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: Active substanceExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.Final score range from 0 to 6, higher score meaning a worse outcome.
Time frame
12 months of treatmentSecondary outcomes
1
Score of the nasal symptoms scale
Symptoms assessed are: itchy nose, sneezing, runny nose, and blocked nose (all rated from 0-3). Final score range from 0 to 3, higher score meaning worse outcome.
Time frame
12 months of treatment2
Score of the specific medication scale
The medication score is 1 for oral and/or topical antihistamines, 2 for intranasal corticosteroids, and 3 for oral corticosteroids. Final score range from 0 to 3, higher score meaning worse outcome.
Time frame
12 months of treatment.3
Percentage of days without symptoms or medication
Percentage of days with a zero value for symptom and medication recorded in the patient digital diary
Time frame
12 months of treatment4
VAS score (completed by the patient and the investigator)
Visual analogue score from 0 (no symptoms) to 100mm (serious symptoms) to assess global symptoms of allergy
Time frame
12 months of treatment.Sponsors and contacts
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Source ClinicalTrials.gov