Potency of HDM Sublingual AIT Tablets in Assuring the Persistency of Asthma Control in HDM Allergic Patients With Severe Asthma, Treated With Tezepelumab

Korábbi kezelés

• Patients treated with a monoclonal antibody for asthma within the previous 3 months or 5 half-lives.
• Patients who have received Sublingual immunotherapy (SLIT) or Sub-Cutaneous Immunotherapy (SCIT) treatment with DermatophagoIdes pteronyssinus and/or Dermatophagoïdes farinae within the previous 5 years.
• Patients received any education provided by a medical indoor environment counselor during the 12 months before the study, or and educational program is programmed during the study.
• The patient who have performed any specific measure for mites' avoidance during the 12 months before the study or plan to implement such measures during the study.
• The patient reports any previous hypersensitivity reaction to the active substance or excipients present in Tezspire® or Acarizax®.
• Patients in an exclusion period determined by a previous study or is currently participating to any other allergy/asthma trial.

Más betegség

• Patients with acute respiratory tract infections.
• Patients with a history of tumor, autoimmune, or immune deficiency pathology.
• Patients with hematological pathology (coagulation disorders, anemia) that could interfere with the blood test.
• Presence of any condition (physical, psychological or other) that might, in the investigator's opinion, hinder study performance.
• The patient is participating in another study for asthma and/or allergy treatment.

Egyéb

• Patients sensitized and regularly exposed to animal dander, molds, and/or cockroach or any another perennial allergen.
• Pregnant, breastfeeding or lactating women.
• Patients unable to read and/or write French language.
• Absence of signed consent.
• Patients who are not beneficiaries of the French social security system.
• The patient is unavailable or unwilling to participate in future visits or is unable to comply with trial protocol.
• Women of childbearing potential and fertile men not using effective contraception.
• Patients under legal protection (guardianship or curatorship)
• Patients with a business or personal relationship with trial staff or sponsor who is directly involved with the conduct of the trial.

• Patients aged ≥ 18 years and ≤ 65 years.
• Patient followed by a specialist in allergy and/or respiratory diseases working at one of the investigating sites in France.
• Patient allergic to HDM and with a clinical history of HDM-allergic asthma.
• Positive specific IgE (≥ 0.35 kUA/L, ImmunoCAP®) and positive skin prick test for Dermtophagoides pteronyssinus and/or Dermtophagoides farinae at screening.
• Patients satisfying diagnostic criteria for severe asthma, according to GINA international guidelines.
• A clinical history of asthma exacerbations in the past two years.
• A history of at least 2 asthma exacerbations during the previous 12 months.
• Uncontrolled asthma (ACT <20/25)
• Lung function measured by FEV1 ≥ 70% of predicted value or according to local requirements.
• Patients with persistent severe asthma who meet the Marketing Authorization criteria for Tezspire® (Tezepelumab) and Acarizax® prescriptions.