Actively Recruiting
Efficacy and Safety of Subcutaneous Immunotherapy (Beltavac) With Polymerized House Dust Mite Extract in Allergic Rhinitis and Rhinoconjunctivitis
Led by Probelte Pharma S.L.U. · Updated on 2024-07-18
350
Participants Needed
18
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the efficacy and safety of Beltavac, a subcutaneous immunotherapy with a polymerized extract of house dust mites, for treating allergic rhinoconjunctivitis with or without asthma. This Phase 3 trial compares Beltavac to a placebo to better understand its effects on symptoms related to house dust mite allergy. Participants receive monthly injections for 12 months following a rush schedule. One group receives the active house dust mite allergoid vaccine derived from Dermatophagoides pteronyssinus and Dermatophagoides farinae, while the other group receives a saline placebo. Treatments are given by subcutaneous route, and the study includes a 13-month follow-up period to monitor reactions and cost-effectiveness. During the trial, participants will complete various assessments including nasal symptom and medication scores, quality of life questionnaires, asthma control tests, and blood tests for specific antibodies. Researchers will monitor local and systemic reactions, symptom-free days, and medication use throughout the 12-month treatment and follow-up. The goal is to provide a comprehensive evaluation of the treatment’s impact on allergic symptoms and asthma control over time.
CONDITIONS
Brief Title
Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent.
- Male or female aged between 12 and 65 years inclusive.
- Moderate or severe persistent rhinitis symptoms according to ARIA Guide.
- Presence or absence of well or partially controlled asthma per GEMA 5.0 Guide.
- Confirmed sensitization to Dermatophagoides pteronyssinus or Dermatophagoides farinae by positive prick test (≥3 mm) and specific IgE class 3 or higher within 6 months.
- Negative pregnancy test.
- Nasal symptom and medication combined score of 1.5 or higher during screening phase.
You will not qualify if you...
- Sensitization to allergens other than dust mites causing relevant symptoms likely to interfere with study.
- Poorly controlled asthma per GEMA 5.0 guideline.
- Severe asthma controlled according to therapeutic step 5-6 of GEMA 5.0 in recent months.
- Autoimmune diseases or immunodeficiency.
- Malignant neoplasms, serious cardiovascular or mental illness, or other chronic diseases affecting study results.
- History of anaphylaxis with cardio/respiratory symptoms.
- Hypersensitivity to any excipients of the investigational product.
- Use of immunosuppressive medication within 6 months before inclusion and during study.
- Treatment with beta-blockers during the study.
- Previous failed immunotherapy with dust mite or other extracts within last 5 years.
- Immunotherapy with other allergens during study period.
- Receipt of any other vaccine one week before treatment start or awaiting second COVID-19 vaccine dose.
- Pregnancy or nursing.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive subcutaneous immunotherapy with either Beltavac or placebo administered monthly according to a rush schedule.
Monthly visits for 12 months
Trial Site Locations
Total: 18 locations
1
Hospital Vega Baja
Orihuela, Alicante, Spain
Actively Recruiting
2
Hospital General de Granollers
Granollers, Barcelona, Spain
Actively Recruiting
3
Hospital de Canarias
Santa Cruz de Tenerife, Canary Islands, Spain
Withdrawn
4
Hospital de la Plana
Castellon, Castellón, Spain
Actively Recruiting
5
Hospital Regional de Málaga
Málaga, Málaga, Spain
Actively Recruiting
6
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Actively Recruiting
7
Fundacion Sanitaria Sant Pere Claver
Barcelona, Spain
Actively Recruiting
8
Hospital de Bellvitge
Barcelona, Spain
Actively Recruiting
9
Hospital Germans Trias i Pujol
Barcelona, Spain
Actively Recruiting
10
Hospital infantil Vall d Hebron
Barcelona, Spain
Actively Recruiting
11
Hospital Val d ' Hebron
Barcelona, Spain
Actively Recruiting
12
Hospital General de Castellón
Castelló, Spain
Actively Recruiting
13
Hospital Virgen de la Arrixaca
Murcia, Spain
Withdrawn
14
Hospital de Fatima
Seville, Spain
Actively Recruiting
15
Hospital Virgen Macarena
Seville, Spain
Actively Recruiting
16
Hospital Clinico Universitario de Valencia
Valencia, Spain
Actively Recruiting
17
Hospital Politecnico de la Fé
Valencia, Spain
Actively Recruiting
18
Hospital Universitario Infantil de la Fé
Valencia, Spain
Actively Recruiting
Research Team
I
Inma Buendia
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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