House Dust Mite Allergy
Conditions
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
Interventions
BIOLOGICALHouse dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae
The vaccine will be administered according to a rush schedule meaning one administration each month for 1 year
BIOLOGICALPlacebo
The vaccine will be administered according to a rush schedule meaning one administration each month for 1 year
Sponsors
Probelte Pharma S.L.U.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The combined nasal symptom and medication score | 12 months of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score of the specific medication scale | 12 months of treatment. | 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. |
| Percentage of days without symptoms or medication | 12 months of treatment | Percentage of days with a zero value for symptom and medication recorded in the patient digital diary |
| VAS score (completed by the patient and the investigator) | 12 months of treatment. | Visual analogue score from 0 (no symptoms) to 100mm (serious symptoms) to assess global symptoms of allergy |
| RCAT questionnaire | 12 months of treatment. | Rhinitis Control Assessment Test. Score from 6 (poor control) to 30 (good control) |
| Mini-RQLQ questionnaires | 12 months of treatment. | Mini-Rhinoconjunctivitis Quality of Life Questionnaire |
| Score of the nasal symptoms scale | 12 months of treatment | 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. |
| Number of local and systemic reactions. | 13 months of study follow up | Number of local and systemic reaccions associated with the treatment |
| Cost-effectiveness analysis | 13 months of study follow up | Number days/ visits related to allergy |
| The combined asthma symptom and medication score | 12 months of treatment | The symptoms assessed are: symptoms during the day, symptoms during the night and physical activity limitations (all rated from 0-3). The medication score is 1 for inhalated corticoids (low dose) , 2 for inhalated corticosteroids associated with LABA, and 3 for inhalated corticosteroids medium dosis associated with LABA. The scores from the symptoms are added and divided by 3 to a total daily symptom score from 0-3. The total daily medication score ranges from 0-3. |
| PEF | 12 months of treatment | Peak expiratory flow measured with a Smart Peak Flow device |
| ACT questionnaire | 12 months of treatment | Asthma Control Test Questionnaire to assess the control of asthma in asthmatic patients |
| Values in serum of specific IgE and IgG4 | 12 months of treatment. | Specific IgE and IgG4 to DPT and total DF, Der p1 and Der p2, Der p23, Der f1, Der f2 |
Countries
Spain
Contacts
Primary ContactInma Buendia
Outcome results
None listed