EUCTR2018-003427-11-ES
Active, not recruiting
Phase 1
Efficacy and safety assessment of a subcutaneous immunotherapy (Beltavac®) with polymerized allergenic extract from house dust mites in patients with allergic rhinitis/rhinoconjuntivitis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Probelte Pharma S.L.U.
- Enrollment
- 350
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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.
Outcomes
Primary Outcomes
Not specified
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