Actively Recruiting
Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM
Led by Probelte Pharma S.L.U. · Updated on 2024-07-18
350
Participants Needed
18
Research Sites
228 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent, signed and dated.
- Man or woman between 12 and 65 years old.
- Moderate or severe symptoms of persistent rhinitis according to the ARIA Guide, with or without well or partially controlled asthma per the GEMA 5.0 Guide.
- Confirmed sensitization to Dermatophagoides pteronyssinus or Dermatophagoides farinae by positive prick test (papule diameter �3 mm) and serum extract-specific IgE class 3 or higher within 6 months prior to study.
- Negative pregnancy test.
- Nasal symptom and medication combined scale score 61.5 during screening phase.
You will not qualify if you...
- Sensitization to allergens other than dust mites with clinically relevant symptoms interfering with study evaluation.
- Poorly controlled asthma according to GEMA 5.0 guideline.
- Severe asthma controlled with therapeutic step 5-6 per GEMA 5.0 guideline in recent months.
- Autoimmune diseases or immunodeficiency.
- Malignant neoplasms, serious cardiovascular disease, serious mental illness, or other chronic diseases interfering with study results.
- History of anaphylaxis with cardio or respiratory symptoms.
- Hypersensitivity to any excipients of the investigational product.
- Use of immunosuppressive medication within 6 months before inclusion and until study end.
- Treatment with beta-blockers during the study.
- Previous immunotherapy with dust mite or other extracts that failed within last 5 years.
- Immunotherapy with allergens other than dust mites during the study period.
- Receipt of any other vaccine one week before treatment start or awaiting second COVID-19 vaccine dose.
- Pregnant or nursing patients.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here