Efficacy and Safety Assessment of a Subcutaneous Immunotherapy (Beltavac®) With Polymerized Allergenic Extract From House Dust Mites in Patients With Allergic Rhinitis/Rhinoconjuntivitis
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 65
Healthy Volunteers: f
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• 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.
Locations
Other Locations
Spain
Fundacion Sanitaria Sant Pere Claver
RECRUITING
Barcelona
Hospital de Bellvitge
RECRUITING
Barcelona
Hospital Germans Trias i Pujol
RECRUITING
Barcelona
Hospital infantil Vall d Hebron
RECRUITING
Barcelona
Hospital Val d ' Hebron
RECRUITING
Barcelona
Hospital General de Castellón
RECRUITING
Castelló
Hospital de la Plana
RECRUITING
Castellon
Hospital General de Granollers
RECRUITING
Granollers
Hospital Regional de Málaga
RECRUITING
Málaga
Hospital Virgen de la Arrixaca
WITHDRAWN
Murcia
Hospital Vega Baja
RECRUITING
Orihuela
Complejo Hospitalario de Navarra
RECRUITING
Pamplona
Hospital de Canarias
WITHDRAWN
Santa Cruz De Tenerife
Hospital de Fatima
RECRUITING
Seville
Hospital Virgen Macarena
RECRUITING
Seville
Hospital Clinico Universitario de Valencia
RECRUITING
Valencia
Hospital Politecnico de la Fé
RECRUITING
Valencia
Hospital Universitario Infantil de la Fé
RECRUITING
Valencia
Contact Information
Primary
Inma Buendia
inmaculadabuendia@probeltepharma.es
+34 608 933 618
Time Frame
Start Date:2022-01-17
Estimated Completion Date:2026-06
Participants
Target number of participants:350
Treatments
Experimental: Active substance
House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae solution administered by the subcutaneous route for 12 months using a rush schedule
Placebo_comparator: Placebo
Saline solution administered by the subcutaneous route for 12 months using a rush schedule