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Clinical Trial of Dermatophagoides farinae, Dermatophagoides pteronyssinus, and Blomia tropicalis Allergen Extracts in Patients with Allergic Rhinitis/Rhinoconjunctivitis With or Without Mild Asthma

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What is this trial about?

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

This clinical trial is studying allergic rhinitis/rhinoconjunctivitis, which causes a runny or blocked nose, sneezing, itching, and eye irritation, with or without mild to moderate asthma, a lung condition that can cause wheezing and shortness of breath. The treatment being tested is an allergen extract made from dust mites and Blomia tropicalis, given as a subcutaneous injection, which means an injection under the skin. The study compares this treatment with placebo to find out whether it is safe and whether it helps reduce allergy symptoms over time.

In the study, participants receive repeated injections over about one year. During this time, symptoms, asthma problems if present, and any unwanted effects are tracked in a diary and during study visits. The study looks at whether the treatment can help control allergy symptoms and improve day-to-day comfort in people allergic to dust mites and Blomia tropicalis.

The study is designed for people with allergy caused by Dermatophagoides pteronyssinus, Dermatophagoides farinae, and Blomia tropicalis, which are types of house dust mites and a related allergen source. The purpose of the study is to evaluate the efficacy and safety of this allergy treatment in rhinitis/rhinoconjunctivitis with or without controlled mild to moderate asthma.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study treatment period

    After joining the study, you receive an injection under the skin of either the active treatment or a placebo. The placebo is the same solution and presentation as the active treatment but without active ingredients.

    The active treatment is D.pteronyssinus/D.farinae/B.tropicalis polymerized extracts 10,000 TU/mL suspension for injection. It contains dust mite and blomia tropicalis allergen extracts. It is given as a subcutaneous injection, which means an injection under the skin.

    The dose of the active treatment is 0.5 ml per administration. The study data do not specify the exact frequency or total duration of each administration schedule, but the trial evaluates treatment over one year.

  2. Step 2

    Daily recording period

    You record symptoms and medication use in the participant's diary during the study.

    The main symptom and medication measure is assessed over 4 weeks after one year of treatment.

    The diary is used to record scores related to nose and eye symptoms, asthma symptoms, and the use of medicines for these symptoms.

  3. Step 3

    Study assessments during treatment

    During the study, your symptoms, medicine use, and treatment response are assessed. These include rhinitis and rhinoconjunctivitis symptoms, asthma symptoms, and combined scores for symptoms and medicine use.

    Asthma exacerbations are also assessed. An asthma exacerbation means a worsening of asthma. The study measures the time until the first worsening, as well as the number, duration, and severity of these episodes.

    Blood or other sample-based tests may be used to measure allergy-related markers, including total igE and specific igE. igE is a type of antibody, which is a protein in the body that is involved in allergic reactions.

    Allergen profiling may be done using the alex technique. This is a laboratory method used to identify allergy-related substances.

    Questionnaires are used to assess quality of life, asthma control, and symptom severity. These include the aqlq (asthma quality of life questionnaire), rqlq (rhinoconjunctivitis quality of life questionnaire), gina 2025 asthma control questionnaire, and a vas (visual analogue scale), which is a simple scale used to rate symptoms or overall impact.

    Safety is monitored throughout the study. This includes any unwanted effects after each administration, reactions at the injection site, systemic reactions, and any medicine used to treat such reactions.

  4. Step 4

    End of one-year treatment evaluation

    After one year of treatment, your combined symptom and medication score for rhinitis and rhinoconjunctivitis is assessed over the following 4 weeks using the participant's diary.

    At this stage, the study compares the active treatment with placebo to evaluate effectiveness and safety.

Who can join the trial?

22 criteria

  • The participant must have signed the informed consent form, which means they have agreed to take part after receiving study information.
  • The participant must be able to follow the study dosing schedule.
  • The participant must be able to record symptoms and medicine use in an electronic diary using a smartphone, or in a paper diary if needed.
  • The participant must have a Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS) of at least 2 out of 6 for at least 10 days, showing moderate-to-severe symptoms.
  • The participant must be a male or female aged 12 to 65 years, including both ages 12 and 65.
  • The participant must have a confirmed history of inhalant allergy with moderate-to-severe persistent rhinitis/rhinoconjunctivitis for at least 1 year, and this must have been treated with anti-allergy medicine.
  • The participant may have mild-to-moderate asthma that is controlled, either intermittent or persistent. Asthma means a long-term condition that makes breathing difficult because the airways become narrow and swollen.
  • The allergy must be caused by Dermatophagoides pteronyssinus, Dermatophagoides farinae, and/or Blomia tropicalis, which are types of house dust mites.
  • The participant must have a positive skin prick test to standardized extracts of Dermatophagoides pteronyssinus, Dermatophagoides farinae, and/or Blomia tropicalis. A skin prick test is a small skin test used to see whether the body reacts to an allergen. The skin reaction must be at least 5 mm wide and at least as large as the reaction to the positive control, which is histamine (a substance used to show that the test works).
  • The participant must have a specific IgE level of at least 3.5 kU/L to a full extract of these mites or to one of their molecular components. IgE is a type of allergy-related antibody, and a higher level can show sensitization to an allergen.
  • If the participant is also sensitized to other aeroallergens (allergens carried in the air), they can only join if all of the following are met: a positive skin prick test to Lepidoglyphus destructor or other mites is allowed only if the specific IgE for that allergen is 3.5 kU/L or less.
  • If the participant has a positive skin prick test to animal dander (tiny flakes of skin or hair from animals), they can join only if exposure is occasional and related symptoms happen only sometimes.
  • If the participant is regularly exposed to animal dander or lives with animals, the skin prick test to those animal danders must be negative.
  • If the participant is sensitized to one or more pollens, the first symptom and medicine recording period must be done outside the pollen season.
  • If the participant is sensitized to pollens, the first symptom and medicine recording period must start at least 1 month before or 1 month after the pollen season.
  • If the pollen-season timing rules cannot be met at the start of the study, the participant cannot be included at that time.
  • If the participant is sensitized to pollens, the final symptom and medicine recording period must also be done outside the pollen season and must start at least 1 month before or 1 month after the pollen season.
  • The study team must be able to check the participant’s situation using the local pollen calendar, which is a calendar showing when pollen is present in the area.
  • The participant must have a negative skin prick test to molds. Molds are fungi that can cause allergic reactions in some people.
  • If the participant is a woman who can become pregnant, she must have started menstruation and must have a negative urine pregnancy test at study entry.
  • If the participant is a woman who can become pregnant, she must agree to use a highly effective contraceptive method during the study and for 1 month after treatment ends.
  • Acceptable contraceptive methods include combined hormonal contraception (contains estrogen and progestogen), hormonal contraception that prevents ovulation (egg release), such as oral, vaginal, or skin patch methods, progestogen-only contraception that prevents ovulation, such as pills, injections, or implants, intrauterine device (IUD), hormone-releasing intrauterine system (IUS), male condom, bilateral tubal occlusion (blocking both fallopian tubes), partner vasectomy, or sexual abstinence.

Who cannot join the trial?

25 criteria

  • People who have had allergen immunotherapy with the study allergens in the last 5 years, or who are currently receiving immunotherapy for any allergen. Immunotherapy means treatment that tries to make the body less sensitive to an allergen.
  • People who have had a respiratory tract infection or an asthma flare-up in the 4 weeks before the screening visit. A respiratory tract infection is an infection of the airways or lungs.
  • People with a history of chronic urticaria (long-lasting hives), severe anaphylaxis (a very serious allergic reaction), or a personal history of hereditary angioedema in the last 2 years. Hereditary angioedema is a condition that causes swelling in the body.
  • People who have any condition in which adrenaline cannot be used safely, such as hyperthyroidism (an overactive thyroid), heart disease, or high blood pressure.
  • People with another serious illness not related to the nose, eyes, or asthma that could affect treatment or follow-up, such as epilepsy or kidney disease.
  • People with uncontrolled autoimmune disease such as thyroiditis or lupus, tumors, or immune deficiency. Autoimmune disease means the immune system attacks the body by mistake.
  • People who would not be able to follow the study rules, or who have a serious mental illness.
  • People with a known allergy to any ingredient in the study treatment, other than the study allergens themselves.
  • People with other lower lung diseases besides asthma, such as emphysema (damage to the air sacs in the lungs), bronchiectasis (widened and damaged airways), or COPD (chronic obstructive pulmonary disease, a long-term lung disease that makes breathing hard).
  • People who have taken medicines that can change skin prick test results, such as antihistamines (allergy medicines), within the required time before testing.
  • People with any nose condition that could make it hard to judge whether the treatment works or is safe, such as nasal polyps (small growths in the nose) or non-allergic rhinitis (nose inflammation not caused by allergy).
  • People who have had any desensitization procedure, such as oral immunotherapy or treatment for milk or egg allergy, unless they have already been in the maintenance phase for at least 12 months. Maintenance phase means the stable long-term part of the treatment.
  • People who need regular treatment with antihistamines or corticosteroids for reasons other than relief of allergic nose symptoms, except for short-term use of up to 15 days for problems like a common cold. Corticosteroids are medicines that reduce inflammation.
  • Pregnant or breastfeeding women.
  • People who are the investigator’s immediate family members.
  • People who are taking part in another clinical trial at the same time, or who took part in another trial within 30 days before the screening visit.
  • People with a history of severe whole-body allergic reactions, including reactions to foods, insect stings (hymenoptera venom), medicines, or similar triggers.
  • People with cancer, whether it is controlled or not.
  • People for whom allergen immunotherapy is absolutely not allowed according to the European allergy society rules.
  • People with asthma that is not fully controlled or only partly controlled.
  • People whose FEV₁ is below 80% of the expected value even after treatment. FEV₁ is the amount of air a person can forcefully breathe out in one second.
  • People with severe asthma who need Step 5 treatment, or Step 4 treatment when asthma is still not controlled and needs Step 5 treatment.
  • People taking beta-blockers by mouth or injection, or ACE inhibitors. Beta-blockers and ACE inhibitors are medicines used for some heart and blood pressure problems.
  • People taking immunosuppressive drugs other than corticosteroids, or taking biological therapies. Immunosuppressive drugs lower the activity of the immune system, and biological therapies are medicines made from living cells.
  • People who need regular systemic corticosteroids by mouth or injection for allergic nose symptoms or asthma. Systemic means the medicine works throughout the whole body. Regular use of corticosteroids placed on the skin, used in the nose or lungs, or taken for atopic dermatitis is allowed.
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Investigated drugs

House dust mite and tropical mite allergy extract injection — This is the study treatment being tested. It contains modified extracts from three types of mites: Dermatophagoides pteronyssinus, Dermatophagoides farinae, and Blomia tropicalis. It is given as an injection under the skin. The goal of this treatment is to help the immune system become less sensitive to these allergens over time, so it may reduce allergy symptoms such as runny nose, sneezing, itchy eyes, and related breathing problems in people with mite allergy.

What is already known about the treatment

  • Placebo

    This is a dummy treatment that looks the same as the active product but contains no active medicine. It is given by the same method as the study treatment, in this trial as a subcutaneous injection, so that results can be compared fairly. A placebo has no direct medical effect and is used in clinical trials to help show whether the real treatment works better than no active treatment.

  • D.pteronyssinus/D.farinae/B.tropicalis polymerized extracts 10,000 TU/mL suspension for injection

    This is an allergy immunotherapy injection made from modified extracts of house dust mites and tropical mite allergens, given under the skin by subcutaneous injection. It is used in medicine to treat allergic rhinitis and rhinoconjunctivitis, and in some patients with mild, well-controlled allergic asthma, when symptoms are caused by these allergens. It belongs to the pharmacological group of allergen extracts, and it works by slowly training the immune system to react less strongly to the allergy triggers over time, helping reduce sneezing, runny nose, itchy eyes, and related symptoms.

Investigated diseases

  • Allergic Rhinitis

    Allergic rhinitis is an inflammation of the lining of the nose caused by an allergic reaction to substances such as dust mites. It usually leads to repeated sneezing, a runny or blocked nose, and itching. Symptoms often come and go with exposure to the allergen, and they may become persistent when exposure is ongoing.

  • Allergic Rhinoconjunctivitis

    Allergic rhinoconjunctivitis is an allergic condition that affects both the nose and the eyes. It commonly causes nasal symptoms together with itchy, red, or watery eyes. The condition may appear seasonally or persist over time when the trigger is present regularly.

  • Allergic Asthma

    Allergic asthma is a type of asthma in which the airways become sensitive to allergens. It causes episodes of wheezing, cough, chest tightness, and shortness of breath. The condition can remain mild and controlled for long periods, but symptoms may worsen when the person is exposed to the allergen.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522773-12-00Protocol codeMM17-SIT-077Estimated enrolment120 patientsSponsorInmunotek S.L.

sourced from the EU Clinical Trials Register and site verification

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