Efficacy and Safety Evaluation for the Treatment of HDM Induced Allergic Asthma and Rhinitis/Rhin⦠(NCT05400811) | Clinical Trial Compass
UnknownPhase 3
Efficacy and Safety Evaluation for the Treatment of HDM Induced Allergic Asthma and Rhinitis/Rhinoconjunctivitis
Spain400 participantsStarted 2022-12
Plain-language summary
Prospective, randomized, placebo-controlled, multicenter of 3 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with mild to moderate asthma and rhinitis/rhinoconjunctivitis (intermittent or persistent) allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
Who can participate
Age range12 Years β 60 Years
SexALL
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Inclusion criteria
β. Signed and dated Informed Consent Form (ICF).
β. Female or male aged 12 to 60 years, both included.
β. 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.
β. Positive skin prick test (wheal major diameter β₯ 5 mm) to a standardized allergen extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
β. 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 β₯ 3.5 kU/L.
β. Women of childbearing age must have a urine pregnancy test negative result before enrolling the study.
β. Women of childbearing age must commit to using an adequate contraception method.
β. Capable of complying with dosage regimen.
Exclusion criteria
β. 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.
β. Positive skin prick test to other aeroallergens, except for intermittent symptoms due to temporary exposition to dander.
β. Those cases in which AIT would be a contraindication according to the criteria of European Allergy and Clinical Immunology Immunotherapy Subcommittee.
β. Uncontrolled or severe asthma and/or FEV1 \<70% despite pharmacological treatment by the time of enrolment.
β. Intake of Ξ²-blockers.
β. Use of immunosuppressive or biological drug.
β. Unstable patients by the time of enrolment (acute exacerbation asthma, respiratory infection, fever, acute pruritus, etc).
β. Patients who have suffered chronic urticaria during the last 2 years, severe anaphylaxis, or family history of angioedema.