A study testing dust mite allergy extracts from Dermatophagoides pteronyssinus and Dermatophagoides farinae for patients with allergic rhinoconjunctivitis with or without controlled asthma

Initial assessment and baseline measurements

At the beginning of the study, several tests will be performed to establish your baseline condition.

Your allergy will be confirmed through a skin prick test (a small needle prick on your skin to test for allergic reactions) to dust mites called Dermatophagoides pteronyssinus and Dermatophagoides farinae. The skin reaction must be at least 3 millimeters in size.

A blood test will be performed to measure specific IgE (proteins in your blood that indicate allergies) to the dust mites and their specific components. The level must be above 0.7 kU/L.

A conjunctival provocation test will be performed, which involves applying dust mite extract to your eye to confirm your allergic reaction.

If you have asthma, a spirometry test will be performed to measure your lung function. Your FEV₁ (the amount of air you can forcefully exhale in one second) must be at least 70% of the expected value.

If you have asthma, a FeNO test will be performed to measure inflammation in your lungs by analyzing your exhaled breath.

You will complete questionnaires to assess your symptoms, quality of life, and asthma control if applicable. These include the RQLQ or AdolRQLQ questionnaire for rhinoconjunctivitis quality of life, and if you have asthma, the AQLQ or pAQLQ for asthma quality of life and the ACT for asthma control.

You will rate your symptoms using a Visual Analogue Scale, which is a line where you mark how severe your symptoms are.

Your cSMS score (a combined score of your symptoms and medication use) must be at least 1.5 points to participate.

An electronic diary application will be installed on your mobile device to record your daily symptoms and medication use throughout the study.

Blood samples will be collected to measure baseline levels of total and specific IgE, total and specific IgG4 (another type of antibody), and total IgA2 against the dust mites.

If you are a woman of childbearing potential, a urine pregnancy test will be performed, which must be negative.

Treatment phase - First 12 administrations

You will receive treatment through subcutaneous immunotherapy, which means injections under your skin.

You will be randomly assigned to receive one of three treatments: Depigoid Mite-Mix at a concentration of 50 DPP/ml, Depigoid FORTE Mite-Mix at a concentration of 150 DPP/ml, or placebo (an inactive substance with no medication).

The treatment contains modified extracts of the dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae.

You will receive a total of 12 injections during this phase.

Throughout this period, you will record your daily symptoms and medication use in the electronic diary on your mobile device. This includes tracking your dSS score (daily symptom score) and dMS score (daily medication score) for rhinoconjunctivitis, and if you have asthma, your dSSa score (daily symptom score for asthma) and dMSa score (daily medication score for asthma).

After the 6th injection, you will complete the same questionnaires as at baseline to assess changes in your symptoms, quality of life, and asthma control if applicable.

After the 12th injection, all baseline assessments will be repeated, including the conjunctival provocation test, blood tests for immunological parameters, spirometry and FeNO if you have asthma, and all questionnaires.

After the 12th injection, you will also complete the ESPIA questionnaire to evaluate your satisfaction with the treatment.

Continuation of treatment - First year

After completing the first 12 injections, you will continue receiving the same treatment through subcutaneous injections.

The injections will continue at regular intervals throughout the first year of treatment.

You will continue recording your daily symptoms and medication use in the electronic diary.

You will continue to monitor any side effects or reactions to the treatment.

At the end of the first year (after completing the first study period), all assessments will be repeated, including the conjunctival provocation test, blood tests, spirometry and FeNO if you have asthma, and all questionnaires including the ESPIA satisfaction questionnaire.

Second year of treatment

You will continue receiving subcutaneous injections of the same treatment throughout the second year.

You will continue recording your daily symptoms and medication use in the electronic diary.

You will continue to monitor any side effects or reactions to the treatment.

At the end of the second year, all assessments will be repeated, including the conjunctival provocation test, blood tests for immunological parameters, spirometry and FeNO if you have asthma, and all questionnaires including the ESPIA satisfaction questionnaire.

Third year of treatment

You will continue receiving subcutaneous injections of the same treatment throughout the third year.

You will continue recording your daily symptoms and medication use in the electronic diary.

You will continue to monitor any side effects or reactions to the treatment throughout the entire three-year treatment period.

The total duration of the treatment phase is three years.

Rescue medications during the study

Throughout the study, you may use rescue medications to manage your symptoms as needed.

For rhinoconjunctivitis symptoms, you may use desloratadine 5 mg tablets taken by mouth, fluticasone furoate 27.5 micrograms nasal spray, or levocabastine 0.5 mg/ml eye drops.

If you have asthma, you may use salbutamol 100 micrograms per dose inhaler, terbutaline 500 micrograms per inhalation powder inhaler, montelukast 10 mg tablets taken by mouth, budesonide 200 micrograms per dose inhaler, or formoterol combined with beclometasone inhalers in various concentrations (100/6 micrograms or 200/6 micrograms per inhalation).

Your use of these medications will be recorded in your electronic diary as part of the study assessments.