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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05395689
Other study ID # PRO-ACAROS-2018-01
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 17, 2022
Est. completion date February 2024

Study information

Verified date May 2022
Source Probelte Pharma S.L.U.
Contact Inma Buendia
Phone +34 608 933 618
Email inmaculadabuendia@probeltepharma.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
House 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
Placebo
The vaccine will be administered according to a rush schedule meaning one administration each month for 1 year

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Probelte Pharma S.L.U.

Country where clinical trial is conducted

Spain, 

Outcome

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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