House Dust Mite Allergy Clinical Trial
— PROACAROSOfficial title:
Efficacy and Safety Assessment of a Subcutaneous Immunotherapy (Beltavac®) With Polymerized Allergenic Extract From House Dust Mites in Patients With Allergic Rhinitis/Rhinoconjuntivitis
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
Status | Recruiting |
Enrollment | 350 |
Est. completion date | February 2024 |
Est. primary completion date | February 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Fundacion Sanitaria Sant Pere Claver | Barcelona | |
Spain | Hospital de Bellvitge | Barcelona | |
Spain | Hospital Germans Trias i Pujol | Barcelona | |
Spain | Hospital infantil Vall d Hebron | Barcelona | |
Spain | Hospital Val d ' Hebron | Barcelona | |
Spain | Hospital General de Castellón | Castelló | |
Spain | Hospital de la Plana | Castellón De La Plana | Castellón |
Spain | Hospital Regional de Málaga | Malaga | Málaga |
Spain | Hospital Virgen de la Arrixaca | Murcia | |
Spain | Hospital Vega Baja | Orihuela | Alicante |
Spain | Complejo Hospitalario de Navarra | Pamplona | Navarra |
Spain | Hospital de Canarias | Santa Cruz De Tenerife | Canarias |
Spain | Hospital de Fatima | Sevilla | |
Spain | Hospital Virgen Macarena | Sevilla | |
Spain | Hospital Clinico Universitario de Valencia | Valencia | |
Spain | Hospital Politecnico de la Fé | Valencia |
Lead Sponsor | Collaborator |
---|---|
Probelte Pharma S.L.U. |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 12 months of treatment | |
Secondary | 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. | 12 months of treatment | |
Secondary | 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. | 12 months of treatment. | |
Secondary | Percentage of days without symptoms or medication | Percentage of days with a zero value for symptom and medication recorded in the patient digital diary | 12 months of treatment | |
Secondary | 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 | 12 months of treatment. | |
Secondary | RCAT questionnaire | Rhinitis Control Assessment Test. Score from 6 (poor control) to 30 (good control) | 12 months of treatment. | |
Secondary | Mini-RQLQ questionnaires | Mini-Rhinoconjunctivitis Quality of Life Questionnaire | 12 months of treatment. | |
Secondary | Values in serum of specific IgE and IgG4 | Specific IgE and IgG4 to DPT and total DF, Der p1 and Der p2, Der p23, Der f1, Der f2 | 12 months of treatment. | |
Secondary | Number of local and systemic reactions. | Number of local and systemic reaccions associated with the treatment | 13 months of study follow up | |
Secondary | Cost-effectiveness analysis | Number days/ visits related to allergy | 13 months of study follow up | |
Secondary | The combined asthma symptom and medication score | 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. | 12 months of treatment | |
Secondary | PEF | Peak expiratory flow measured with a Smart Peak Flow device | 12 months of treatment | |
Secondary | ACT questionnaire | Asthma Control Test Questionnaire to assess the control of asthma in asthmatic patients | 12 months of treatment |
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