Efficacy of SQ house dust mite (HDM) sublingual immunotherapy-tablet in Thai patients with HDM respiratory allergy

Abbott Laboratories Limited0 个研究点目标入组 50 人开始时间: 2020年5月15日最近更新: 2024年8月19日

适应症

试验速览

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•1. Male or female with age of 18-65 years for allergic rhinitis with or without asthma
•2. Clinical history and a positive test of house dust mite sensitization (skin prick test and specific IgE test) with confirmed diagnosis of either one of the following:
•3. Persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication
•4. House dust mite induced asthma not well controlled by inhaled corticosteroids and associated with mild to severe HDM allergic rhinitis
•5. Positive skin prick test (SPT) response to Dermatophagoides pteronyssinus (Dp) or Dermatophagoides farinae (Df) (wheal diameter >5 mm or wheal diameter >3 mm larger than negative control) by using standardized solution (Alk-Abello AS) Or Positive specific IgE against Dp or Df (> IgE Class 2; > 0.70 kU/L).
•6. Positive SPT to other allergens should be weak with wheal diameter <5 mm.
•7. FEV1 > 70% of predicted value (for AA patients) after adequate pharmacologic treatment.

•1. A relevant clinical history of perennial allergic rhinitis with or without asthma caused by other allergens.
•2. Clinical history of uncontrolled asthma within 3 months prior to screening.
•3. Previous treatment with immunotherapy with HDM allergen for more than 1 month within the last 5 years.
•4. Inflammatory conditions in the oral cavity or severe oral mycosis at visit 1.
•5. Symptoms of or treatment for upper respiratory tract infection
•6. Structural lung disease (e.g. chronic obstructive pulmonary disease (COPD), bronchitis, old pulmonary tuberculosis)

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