Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites

Launched by INMUNOTEK S.L. · Jun 15, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option for people suffering from allergies caused by dust mites, which can lead to conditions like allergic rhinitis (a runny or stuffy nose) and asthma. The researchers want to see how effective and safe a specific type of treatment, known as subcutaneous immunotherapy (which involves regular injections), is for patients aged 14 to 65 who have been diagnosed with these allergies and asthma. Participants will be randomly placed in one of three groups: two groups will receive the actual treatment, while one group will receive a placebo (a harmless dummy treatment).

To be eligible for the trial, participants need to have a clear history of asthma and allergy symptoms related to dust mites, confirmed by specific allergy tests. They should also be stable enough to participate, meaning their asthma and allergies are not severely uncontrolled. Participants can expect to attend appointments for their treatment and to help track their symptoms using a smartphone app. It's also important to know that women who can become pregnant will need to confirm they are not pregnant and agree to use contraception during the trial. If you or someone you know fits this description and is interested, this trial could be an opportunity to explore a potential new treatment for dust mite allergies and related asthma symptoms.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Written informed consent.
• • Age between 12 and 65, both genders.
• • Subjects with a confirmed clinical history of inhalant allergy (intermittent or persistent moderate-severe rhinitis and/or rhinoconjunctivitis according to the ARIA classification with or without intermittent or persistent mild-moderate controlled asthma according to the GEMA 5.0 definition) caused by allergy to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent.
• • Subjects with a positive skin prick-test wheal size \>5 mm higher diameter due to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The positive and negative control of the test should give consistent results. The results will be valid 12 months prior to the signing of the informed consent.
• • Specific immunoglobulin E against house dust mites \>3,5 KU/mL (InmunoCAP® o Immulite), for the complete extract of Dermatophagoides pteronyssinus and / or for Dermatophagoides farinae or for some of the molecular components of these allergenic sources
• * Subjects should preferably be monosensitized to the study allergens. In case of subjects sensitized to other aeroallergens, only those with the following characteristics may be included in the study:
• • Subjects with positive skin test to Blomia tropicalis and Lepidoglyphus destructor, whose specific IgE values do not exceed or equal the values for the study allergens. The maximum specific IgE value for these allergens is 3.5 KU/L.
• • Subjects with positive skin tests to epithelia, as long as they present occasional exposure and symptomatology.
• • Subjects with positive skin tests to pollens, whose specific IgE values do not exceed or equal the values of the allergens in the study and who do not present exacerbations during the pollen season. The maximum value of specific IgE for these allergens is 17.5 KU/L.
• • Subjects with negative skin test for fungi
• • Women of childbearing age (from menarche) must present a urine pregnancy test with a negative result at the time of joining the trial, before the first administration of the IMP.
• • Women of childbearing age participating in the trial must agree to use an appropriate method of contraception, meaning any act, device, or medication to prevent conception or viable pregnancy, during the trial if they are sexually active.
• • Subjects with a diagnosis of asthma according to the GEMA 5.0 guideline.
• • Subjects capable of complying with the dosing regimen.
• • Subjects who own an smartphone for symptom registration and medication
• Exclusion Criteria:
• • Subjects who have received previous immunotherapy in the previous 5 years to dander, fungi, and mites.
• • Subjects in whom immunotherapy may be subject to an absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and the European Allergy and Clinical Immunology Immunotherapy Subcommittee.
• • Subjects with persistent severe or uncontrolled asthma, with an FEV1\<70% of baseline despite adequate pharmacological treatment at the time of inclusion in the trial. Also subjects with intermittent or persistent rhinitis/rhinoconjunctivitis with severe symptoms in whom oral or systemic antihistamine therapy is contraindicated.
• • Subjects who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
• • Subjects under treatment with β-blockers.
• • Clinically unstable subjects at the time of inclusion in the trial (acute asthma exacerbation, respiratory infection, feverish process, acute urticaria, etc.).
• • Subjects with chronic active urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin prick test will be performed, or a history of hereditary angioedema.
• • Subjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor impairment, uncontrolled diabetes, malformations, multiple surgeries, nephropathy).
• • Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies.
• • Subject whose condition prevents him/her from offering cooperation and/or who has serious mental illness.
• • Subjects with a known allergy to other components of the investigational medicinal product other than the allergen.
• • Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis.
• • Direct investigator's relatives.
• • Pregnant women or breastfeeding women.