Efficacy and Safety Evaluation for the Treatment of HDM Induced Allergic Asthma and Rhinitis/Rhinoconjunctivitis

Launched by INMUNOTEK S.L. · May 27, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a treatment called subcutaneous immunotherapy for people with allergies caused by house dust mites. The trial focuses on patients who have mild to moderate asthma and conditions like allergic rhinitis or rhinoconjunctivitis, which cause symptoms such as sneezing, runny nose, and difficulty breathing. Participants will be randomly assigned to receive either the active treatment or a placebo (a harmless substance with no active ingredients) to see how well the treatment works in reducing allergy symptoms.

To participate in this trial, individuals must be between 12 and 60 years old and have a confirmed allergy to house dust mites, verified by a skin test or blood test. They should also be able to use a smartphone to record their symptoms and any medications they take. However, certain people, such as those with severe asthma or other serious health conditions, as well as pregnant or breastfeeding women, will not be eligible. Participants can expect regular check-ups and support throughout the study to monitor their health and any reactions to the treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed and dated Informed Consent Form (ICF).
• • 2. Female or male aged 12 to 60 years, both included.
• • 3. Confirmed clinical history of inhalation allergy (mild-moderate controlled intermittent or persistent asthma according to the definition of GEMA 5.0 and GINA 2020 and intermittent or persistent rhinitis / rhinoconjunctivitis according to the ARIA classification, caused by Dermatophagoides pteronyssinus and / or Dermatophagoides farinae). The asthma diagnosis will be valid up to 24 months prior to signing the informed consent.
• • 4. Positive skin prick test (wheal major diameter ≥ 5 mm) to a standardized allergen extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
• • 5. Specific IgE against a complete extract of D. pteronyssinus and/or D. farinae or any of the molecular components of allergenic sources with a value ≥ 3.5 kU/L.
• • 6. Women of childbearing age must have a urine pregnancy test negative result before enrolling the study.
• • 7. Women of childbearing age must commit to using an adequate contraception method.
• • 8. Capable of complying with dosage regimen.
• • 9. Owning a smartphone to register symptoms and medication consumption.
• • 10. A negative skin prick test to other aeroallergens with specific IgE \< 3.5 kU/L with no clinical relevance.
• Exclusion Criteria:
• • 1. Previous immunotherapy to any of the tested allergen during the last 5 years or any desensitization process in the last 2 years (ITO, milk, egg, ...) or currently receiving immunotherapy with any other allergen.
• • 2. Positive skin prick test to other aeroallergens, except for intermittent symptoms due to temporary exposition to dander.
• • 3. Those cases in which AIT would be a contraindication according to the criteria of European Allergy and Clinical Immunology Immunotherapy Subcommittee.
• • 4. Uncontrolled or severe asthma and/or FEV1 \<70% despite pharmacological treatment by the time of enrolment.
• • 5. Intake of β-blockers.
• • 6. Use of immunosuppressive or biological drug.
• • 7. Unstable patients by the time of enrolment (acute exacerbation asthma, respiratory infection, fever, acute pruritus, etc).
• • 8. Patients who have suffered chronic urticaria during the last 2 years, severe anaphylaxis, or family history of angioedema.
• • 9. Having any contraindication for the use of adrenaline (hyperthyroidism, heart disease, high blood pressure).
• • 10. Other severe diseases not related to allergic asthma or rhinitis that could interfere in the study treatment or the follow-up (epilepsy, psychomotor agitation, diabetes, malformations, nephropathy) according to medical criteria.
• • 11. Autoimmune diseases (thyroiditis, lupus, etc.), tumoral diseases or immunodeficiencies.
• • 12. Participants that the investigator believes could not comply with the study protocol or have serious psychiatric disorders.
• • 13. Known allergy to any of the ingredients of the study medication except for mites.
• • 14. Lower respiratory tract diseases different from asthma as bronchiectasis or chronic obstructive pulmonary disease.
• • 15. Breast-feeding or pregnant women.
• • 16. Being immediate family of the investigator.
• • 17. Concurrent participation in other clinical trials or prior participation within 30 days prior to inclusion.
• • 18. History of serious systemic reactions, including food, Hymenoptera venom, medications, etc.