Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating Subcutaneous Immunotherapy in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma Sensitized to Dust Mites

What this Trial Is About

Researchers are evaluating the effectiveness and safety of subcutaneous immunotherapy (SCIT) in people aged 12 to 65 who have allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma. The study focuses on patients sensitized to specific house dust mites, Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. This is a phase 3, double-blind, placebo-controlled, randomized trial conducted at multiple centers. Participants will be randomly assigned to one of three groups: two receive different doses of SCIT (10,000 TU/mL or 30,000 TU/mL of allergenic extract), and one receives a placebo injection without active ingredients. Treatment lasts for one year, with doses administered subcutaneously. The study compares the two active treatment groups to the placebo group to determine which dose may be more effective and safe. During the trial, participants will be closely monitored for symptoms and medication use, assessed by the Combined Symptoms and Medication Score (CSMS) over 12 months. Researchers will also track medication-free days, symptom-free days, quality of life related to asthma and rhinitis, adverse events, and immunological responses. Participants will log symptoms and medication use via smartphone. Safety and treatment effects will be evaluated throughout the study period.

Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites