/A

Phase 1

• Conditions: Allergic rhinitis/ rhinoconjuntivitis associated or not with asthma; MedDRA version: 21.1Level: LLTClassification code 10001724Term: Allergic rhinitis (excl hay fever)System Organ Class: 100000004855; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-003427-11-ES
• Lead Sponsor: Probelte Pharma S.L.U.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-14
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 350

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified