Study of sublingual immunotherapy with Dermatophagoides pteronyssinus and Dermatophagoides farinae allergen mix for patients with dust mite allergic rhinitis

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What is this study about?

This study focuses on allergic rhinitis and rhinoconjunctivitis caused by dust mite allergy. The treatment being tested is a mixture of two types of dust mite allergens (Dermatophagoides pteronyssinus and Dermatophagoides farinae) given as a spray under the tongue. The purpose is to find the most effective dose of this allergy treatment that can help patients while remaining safe.

The study will compare different strengths of the allergen mixture (1000, 3000, and 6000 TBU/ml) against a placebo. The medication or placebo will be given as a sublingual spray, which means it is sprayed under the tongue. Participants will receive daily doses for 4 months. To measure how well the treatment works, doctors will perform a nasal provocation test, which involves putting a small amount of allergen in the nose and measuring breathing changes.

During the study, participants will have various tests to check their allergy responses, including skin prick tests and blood tests to measure antibody levels. Doctors will also monitor any side effects and keep track of how often participants need to use other allergy medications. The treatment is designed for people who have allergic reactions to dust mites, which can cause symptoms like sneezing, runny nose, and itchy eyes.

1 Initial assessment

You will undergo several tests to confirm your eligibility, including skin prick tests and blood tests to measure specific antibodies against dust mites

A nasal provocation test will be performed to measure your sensitivity to dust mites

Your lung function will be tested if you have asthma

2 Treatment assignment

You will be randomly assigned to receive one of four treatments:

– Dust mite extract spray at 1000 TBU/ml concentration

– Dust mite extract spray at 3000 TBU/ml concentration

– Dust mite extract spray at 6000 TBU/ml concentration

– Placebo spray (containing salt solution)

3 Treatment period

The treatment will be administered as a sublingual spray (under the tongue)

The treatment period will last from September 2025 to February 2026

You will need to keep track of any additional medications used during the study period

4 Monitoring

Your response to treatment will be monitored through nasal breathing measurements

Any side effects or reactions will be recorded throughout the study

Regular assessments of your allergy symptoms will be conducted

5 Final evaluation

At the end of the study, you will undergo:

– Final nasal provocation test

– Repeat skin prick tests

– Final blood tests to measure antibody levels

– For women of childbearing age: a pregnancy test

Who Can Join the Study?

Age must be between 14 and 50 years old
Must have allergic rhinitis (inflammation of the nose causing sneezing and runny nose) with or without eye inflammation, with or without asthma. If asthma is present, lung function tests must show:
– FEV₁ (amount of air exhaled in first second) above 70% of normal
– FVC (total amount of air that can be exhaled) above 80% of normal
Must have a positive skin prick test (allergy test where small amounts of allergens are placed on the skin) to dust mites, showing a reaction at least 5mm larger than control test, done within last 12 months
Must have specific blood antibodies (IgE) to dust mites measuring at least 0.70 kU/L, tested within last 6 months
Must have a positive nasal provocation test (test where allergen is applied to nose to confirm allergy) at maximum concentration of 1/10
Must sign informed consent form to participate
For women who can become pregnant: must have negative pregnancy test at start of study and will need another test at end of treatment
Must not have received any allergy shots or treatments (immunotherapy) for dust mites or other allergens during the study period

Who Cannot Join the Study?

History of severe allergic reactions or anaphylaxis (life-threatening allergic reactions)
Current use of other allergy immunotherapy treatments
Pregnancy or breastfeeding
Severe asthma or uncontrolled respiratory conditions
Active autoimmune diseases (conditions where the immune system attacks healthy cells)
Serious chronic diseases that are not well controlled
Use of medications that could interfere with the study treatment
History of non-compliance with medical treatments
Participation in another clinical trial within the past 30 days
Severe oral infections or injuries in the mouth
Known allergies to any components of the study medication
Inability to follow study procedures
Mental conditions that could affect the ability to provide informed consent
Substance abuse or addiction
Major surgery planned during the study period

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital General Universitario De Castellon	Castello De La Plana	Spain
Hnbauuwu Fztdkjti Shoa Piol Crpkse	Barcelona	Spain
Hrwnbdoi Ex Pylrg &hqaurw Qfxfwphtjsk	Barcelona	Spain
Hotpdfxi Do Lm Syelw Ccve I Swjm Pdb	Barcelona	Spain
Hbvqruvf Uqatffihmxgku Hexqmutt Tczaj y Pzyomo Isvvbncz Ctlrmp djacekhotftnlcmup (btyv	Badalona	Spain
Hgnseqxt Vcsh dtxxttmc	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.09.2025

Trial locations

Investigated drugs:

Dermatophagoides mix (containing house dust mites D. pteronyssinus and D. farinae) is an allergen extract used in sublingual immunotherapy. This treatment is administered under the tongue and works by gradually exposing the patient to house dust mite allergens. The purpose is to help reduce allergic reactions by training the immune system to become less sensitive to these specific allergens over time.

Placebo is an inactive substance that looks identical to the real treatment but contains no active ingredients. It is used as a comparison to measure the effectiveness of the active treatment.

Investigated diseases:

Allergic Rhinitis – A common allergic condition that occurs when the immune system reacts to dust mites in the air, causing inflammation of the nasal passages and conjunctiva of the eyes. The condition is characterized by symptoms such as sneezing, runny nose, nasal congestion, itchy nose, and watery eyes. These symptoms typically worsen when exposed to house dust mites, particularly species like Dermatophagoides pteronyssinus and Dermatophagoides farinae. The condition can be persistent throughout the year since dust mites are present in indoor environments. The allergic response occurs when the body’s immune system overreacts to normally harmless dust mite proteins.

Trial ID:

2025-521522-15-00

Protocol code:

APISLIT-DD-D-2025-01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of sublingual immunotherapy with Dermatophagoides pteronyssinus and Dermatophagoides farinae allergen mix for patients with dust mite allergic rhinitis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?