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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

8 criteria

  • 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 trial?

15 criteria

  • 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
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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.

What is already known about the treatment

Dermatophagoides mix (D. pteronyssinus + D. farinae) – A sublingual immunotherapy medication administered as liquid drops under the tongue, containing a standardized mixture of two house dust mite allergen extracts. This treatment is specifically designed to help patients with allergic rhinitis and rhinoconjunctivitis caused by dust mite allergies, working by gradually desensitizing the immune system to these specific allergens. The medication belongs to the class of allergen-specific immunotherapy products and functions by modifying the body's immune response to dust mite allergens, helping to reduce allergic symptoms over time through regular administration. The dosage is carefully standardized in Therapeutic Biological Units (TBU/mL) to ensure consistent therapeutic effect while maintaining safety.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521522-15-00Protocol codeAPISLIT-DD-D-2025-01Estimated enrolment120 patientsSponsorAdvanced Outcomes Research S.L.

sourced from the EU Clinical Trials Register and site verification

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