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Tests treatment safety and results for House Dust Mite Allergy
Official title Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM
ClinicalTrials.gov ID: NCT05395689
What this study is testing
What is House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae?
House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae is an investigational medicine, being studied as a potential treatment for house dust mite allergy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 65
You may be able to join if
- 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...
- 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...
- Negative pregnancy test.
You likely can't join if
- Concomitant sensitization to allergens other than dust mites if clinically relevant symptoms are anticipated that may interfere with study evaluation...
- 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...
- Clinical history of anaphylaxis with cardio / respiratory symptoms.
See the full eligibility 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...
- Negative pregnancy test.
- Nasal symptom and medication combined scale score ≥ 1.5 during the screening phase.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Orihuela, Alicante, Spain
- Granollers, Barcelona, Spain
- Santa Cruz de Tenerife, Canary Islands, Spain
- Castellon, Castellón, Spain
- Málaga, Málaga, Spain
- Pamplona, Navarre, Spain
- Barcelona, Spain
- Castelló, Spain
- Murcia, Spain
- Seville, Spain
- Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orihuela, Alicante, Spain; Granollers, Barcelona, Spain; Santa Cruz de Tenerife, Canary Islands, Spain; Castellon, Castellón, Spain; Málaga, Málaga, Spain; Pamplona, Navarre, Spain and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.