In short
This article discusses a clinical trial investigating the effectiveness and safety of Beltavac®, a subcutaneous immunotherapy treatment for allergic rhinitis caused by house dust mites. The study aims to assess the drug's efficacy in controlling symptoms, improving quality of life, and its overall safety profile in patients aged 12 to 65 with moderate to severe persistent rhinitis.
At a glance
- Study Drug
- Beltavac® (Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae polymerized with glutaraldehyde)
- Administration
- Subcutaneous injection
- Target Condition
- Allergic rhinitis/rhinoconjunctivitis due to house dust mites
- Study Population
- Males and females aged 12-65 with moderate to severe persistent rhinitis
- Primary Objective
- Assess efficacy of 12-month subcutaneous rush immunotherapy
- Primary Endpoint
- Combined Symptom and Medication Score (CSMS4)
- Secondary Objectives
- Assess efficacy in controlling symptoms, safety, quality of life impact, immunoglobulin levels, economic assessment
- Treatment Duration
- 12 months
- Maximum Daily Dose
- 0.5 ml
What is BELTAVAC?
BELTAVAC is a medication used in subcutaneous immunotherapy for treating allergies caused by house dust mites. It contains a mixture of allergen extracts from two types of dust mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae. These extracts are polymerized with glutaraldehyde, which means they are chemically modified to improve their effectiveness and safety.
How Does BELTAVAC Work?
BELTAVAC works by gradually exposing your immune system to small amounts of house dust mite allergens. Over time, this exposure helps your body build tolerance to these allergens, reducing allergic reactions. This type of treatment is known as immunotherapy, which aims to modify the underlying cause of the allergy rather than just treating the symptoms.
Medical Conditions Treated
BELTAVAC is primarily used to treat:
- Allergic rhinoconjunctivitis due to house dust mite exposure. This condition involves inflammation of the nose (rhinitis) and eyes (conjunctivitis) caused by an allergic reaction to dust mites.
- House dust mite allergy, which can cause various symptoms affecting the respiratory system and eyes.
Clinical Trial Objectives
A clinical trial is being conducted to evaluate BELTAVAC's effectiveness and safety. The main objectives of this trial include:
- Assessing the efficacy of BELTAVAC in treating allergic rhinitis caused by house dust mites over a 12-month period.
- Evaluating its effectiveness in controlling rhinoconjunctivitis symptoms.
- Measuring its overall impact on allergic symptoms.
- Assessing the safety profile of the treatment.
- Evaluating its effect on patients' quality of life.
- Measuring changes in specific immunoglobulin levels in the blood. Immunoglobulins are antibodies produced by the immune system in response to allergens.
- Conducting an economic assessment of its clinical effects.
Eligibility Criteria
To participate in the BELTAVAC clinical trial, patients must meet certain criteria. Some key inclusion criteria are:
- Age between 12 and 65 years.
- Moderate to severe persistent rhinitis symptoms, with or without well-controlled asthma.
- Confirmed sensitization to house dust mites through skin prick tests and blood tests.
- A minimum score on a combined symptom and medication scale during a screening phase.
Some exclusion criteria include:
- Poorly controlled or severe asthma.
- Autoimmune diseases or immunodeficiency.
- History of severe allergic reactions (anaphylaxis) with heart or breathing problems.
- Recent use of certain medications that affect the immune system.
- Pregnancy or breastfeeding.
Effectiveness Measures
The trial uses several measures to evaluate how well BELTAVAC works:
- Combined Symptom and Medication Score (CSMS4): This score measures both the severity of allergy symptoms and the amount of medication needed to control them.
- Nasal Symptom Score (SS4): This focuses specifically on nasal allergy symptoms.
- Medication Score (MS): This measures the amount of allergy medication used.
- Nasal and Ocular Symptom Score (SS6): This includes both nasal and eye-related allergy symptoms.
- Combined Nasal, Ocular Symptom and Medication Score (CSMS6): This comprehensive score includes nasal symptoms, eye symptoms, and medication use.
- Percentage of days without symptoms or medication use.
Administration and Dosage
BELTAVAC is administered as a subcutaneous injection, which means it's injected under the skin. The maximum daily dose is 0.5 ml, and the treatment period can last up to 12 months. It's important to note that this information is based on the clinical trial data, and the exact dosage and duration may vary depending on individual patient needs and responses to the treatment.