Study on the Effectiveness and Safety of Beltavac for Patients with Allergic Rhinitis from House Dust Mites

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for allergic rhinitis and rhinoconjunctivitis caused by exposure to house dust mites. The treatment being tested is called BELTAVAC, which is an injectable solution containing a mixture of allergen extracts from house dust mites, specifically Dermatophagoides pteronyssinus and Dermatophagoides farinae, combined with a substance called glutaraldehyde. This study will also use a placebo, which is a saline solution without the allergenic extract.

The purpose of the study is to evaluate the effectiveness and safety of this treatment when given as a subcutaneous injection, which means it is injected under the skin. Participants will receive the treatment over a period of 12 months. The study aims to see if this treatment can help reduce the symptoms of allergic rhinitis, which include sneezing, runny or blocked nose, and itchy eyes, among others.

Throughout the study, participants will be asked to keep track of their symptoms and any medication they use in an online patient diary. This will help researchers understand how well the treatment is working. The study will also look at how many days participants can go without symptoms or needing medication. The results will help determine if BELTAVAC is a safe and effective option for people with allergies to house dust mites.

1 initial visit and consent

Upon joining the clinical trial, the first step involves an initial visit where informed consent is obtained. This means signing a document that explains the trial and confirms understanding and willingness to participate.

During this visit, eligibility is confirmed based on age, symptoms of allergic rhinitis, and a positive test for house dust mite sensitivity.

2 screening phase

The screening phase lasts for 4 weeks. During this time, an electronic patient record is maintained to track symptoms and medication use.

For women who can become pregnant, a negative pregnancy test is required, and contraception must be used for at least one month before the visit and throughout the trial.

3 treatment phase

The treatment phase involves receiving subcutaneous injections of Beltavac, which contains a polymerized extract of house dust mites. This phase lasts for 12 months.

Injections are administered under the skin, and the frequency and dosage are determined by the study protocol.

4 monitoring and recording

Throughout the trial, daily records of nasal symptoms and medication use are maintained in an online patient card.

Regular assessments are conducted to evaluate the effectiveness and safety of the treatment.

5 follow-up and evaluation

The trial includes periodic follow-up visits to monitor progress and any side effects.

The primary goal is to assess the improvement in symptoms and the reduction in medication use over the course of the year.

Who Can Join the Study?

Provide a signed and dated written consent to participate.
Be a male or female aged between 12 and 65 years.
Have moderate or severe symptoms of ongoing rhinitis (a condition causing a runny or stuffy nose) as per the ARIA Guide, with or without asthma that is well or partially controlled according to the GEMA Guide.
Show confirmation of sensitivity to house dust mites through a positive skin prick test (a test where a small amount of allergen is placed on the skin to check for a reaction) with a wheal (raised, red area) of 3 mm or more, and a specific IgE (a type of antibody) level of class 3 or higher within 6 months before the study.
If female and capable of becoming pregnant, use contraception for at least 1 month before the study and agree to continue using it during the study.
Be willing and able to complete an electronic patient record during the 4-week screening period.
For the treatment phase, have a negative pregnancy test.
Have a combined symptom and medication score (ESMR4) of 1.5 or higher during the screening phase.
Be willing and able to complete an electronic patient record for a 12-week period during the treatment phase.
For patients with asthma, have an Asthma Control Test (ACT) score greater than 19.
For patients with asthma, have a Peak Expiratory Flow (PEF) value greater than 80% of their personal best at the time of the visit.

Who Cannot Join the Study?

Patients who have a severe allergy to the treatment being tested.
Patients with a history of severe allergic reactions, known as anaphylaxis, which is a serious and potentially life-threatening reaction.
Patients who are currently taking medications that could interfere with the study treatment.
Patients with any other medical condition that the study doctors believe could make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients who are unable to follow the study procedures or attend the required visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Universitario De La Plana	Villarreal	Spain
Hospital General De Granollers	Granollers	Spain
Hospital Clinico Universitario De Valencia	Valencia	Spain
Hospital Universitario Virgen Macarena	Sevilla	Spain
Hospital General Universitario De Castellon	Castello De La Plana	Spain
Huvlrpzw dt Fznzvk	Sevilla	Spain
Hkxlfyls Voty Bsch Dw Osnucfcs	Orihuela	Spain
Hgbhgtbl Fretnala Skwd Pndl Cmmskt	Barcelona	Spain
Hjzeqisg Uownqacxelnsm Ryvykisv Du Mtgehg	Malaga	Spain
Hkznivlv Ushqwkwtfthzw Httokcrr Tkvir y Pueqgc Iqbspanl Ccakob dakehhlhgibduniyx (wwrk	Badalona	Spain
Hdhmzubf Vcum dfcakbzs	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	17.01.2022

Trial locations

Investigated drugs:

Mixture Of Allergen Extracts Of Dermatophagoides Pteronyssinus And Dermatophagoides Farinae Polymerized With Glutaraldehyde

Beltavac® is a type of treatment called subcutaneous immunotherapy. It is designed to help people who are allergic to house dust mites. This therapy involves injecting a small amount of a special mixture under the skin. The mixture contains allergenic extracts from house dust mites that have been modified to be less likely to cause a strong allergic reaction. The goal of this treatment is to gradually train the immune system to become less sensitive to these allergens, which can help reduce symptoms like sneezing, runny nose, and itchy eyes. This process is sometimes referred to as “rush immunotherapy” because it aims to achieve results more quickly than traditional methods. The treatment is given over a period of 12 months to help manage symptoms of allergic rhinitis or rhinoconjunctivitis, which are conditions that affect the nose and eyes.

Allergic rhinoconjunctivitis due to exposure of house dust mites – This condition is an allergic reaction that affects the nose and eyes, triggered by exposure to house dust mites. It involves inflammation of the nasal passages and conjunctiva, the membrane covering the eyes. Symptoms typically include sneezing, nasal congestion, runny nose, itchy eyes, and watery eyes. The condition progresses with repeated exposure to allergens, leading to persistent or worsening symptoms. Over time, individuals may experience increased sensitivity to other allergens. The severity of symptoms can vary depending on the level of exposure and individual sensitivity.

Trial ID:

2024-516893-31-01

Protocol code:

PRO-RCT-ACAROS-2018

NCT ID:

NCT05395689

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Beltavac for Patients with Allergic Rhinitis from House Dust Mites

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?