The aim of this drug trial is to evaluate the annualized asthma exacerbation rate under treatment with Acarizax versus placebo. The trial is intended for adults aged 18 to 65 with severe uncontrolled asthma and a house dust mite allergy. The study will involve 32 patients (up to 38 with study dropouts) recruited from French hospitals, in pulmonology and allergology departments.
Initially, all participants will receive Tezepelumab for 3 to 6 months (M-3/-6) to control asthma symptoms. If asthma is not controlled after 6 months, the participant will be excluded from the study and will continue on standard treatment.
Once their asthma is controlled, patients will be randomized in two groups:
* Group A: Tezepelumab + Acarizax® * Group B: Tezepelumab + Placebo After 6 months of treatment with Acarizax or placebo (M6), Tezepelumab will be stopped and participants will continue treatment with Acarizax or placebo alone for a further 12 months (up to M18/End of search).
The study will include 5 visits during regular consultations (M-3/M-6, D0, M6, M12 and M18), as well as 2 follow-up telephone calls M3 and M9).
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 sensitized and regularly exposed to animal dander, molds, and/or cockroach or any another perennial allergen.
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.
Parallel
Tezepelumab
DrugPatients will take Tezepelumab for 3 to 6 months (M-3/-6) to control asthma symptoms. Once asthma symptoms are controlled (D0), patients will take an additionnal of 18 months of Tezepelumab
Acarizax
DrugOnce asthma symptoms are controlled (D0), patients will take 18 months of Acarizax.
Placebo
DrugOnce asthma symptoms are controlled (D0), patients will take 18 months of Placebo.
Annualized total number of asthma exacerbations under acarizax/placebo treatment
The number of asthma exacerbations will be recorded by the participant in their follow-up diary throughout the Acarizax or placebo treatment period. Day 0 marks the start of Acarizax/placebo treatment, and Month 18 marks the end.
Annualized total number of asthma exacerbations without Tezepelumab
The number of asthma exacerbations will be recorded by the participant in their follow-up diary throughout the entire trial. Month 6 marks the end of Tezepelumab treatment, and Month 18 marks the end of Acarizax/placebo treatment.
ACT score
The primary purpose of the Asthma Control Test is to provide a systematic way to evaluate how well a patient's asthma is controlled. The test consists of 5 questions that cover different aspects of asthma control (Frequency of symptoms, limitations on Activities, Nighttime Symptoms, Need for rescue Medication, Self-Assessment). Each question is crafted to elicit information on the patient's experience over the past 4 weeks. The possible scores for each question range from 1 to 5. The total score can range from 5 to 25. A 2-points increase in the score has been proven to be statistically significant.
ARCT score only for patients suffering from allergic rhinitis
This test has been validated for assessing allergic rhinitis control and identifying severe allergic rhinitis. The test consists of 5 questions that cover different aspects of allergic rhinitis (Impact on daily life, Quality of life, Nighttime Symptoms, Need for rescue Medication, Self-Assessment). Each question is crafted to elicit information on the patient's experience over the past 2 weeks. The total score can range from 5 to 25. A 2-points increase in the score has been proven to be statistically significant.
Forced Expiratory Volume (FEV1)
Spirometry result: Forced Expiratory Volume in 1 second (L).
Click on the lead sponsor to view all of their trials.
University Hospital, Montpellier
Lead sponsor
AstraZeneca
Collaborator
ALK-Abelló A/S
Collaborator
University hospital of Nîmes
Collaborator
ThermoFisher Scientific Brahms Biomarkers France
Collaborator
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