To evaluate the efficacy and safety of different doses of Sublingual Film for Dermatophagoides Pteronyssinus in adult patients with Dust Mite Allergic Rhinitis via a randomized, double-blind, placebo-controlled Phase II clinical trial, and to explore the optimal dose for the Phase III clinical trial.
This study consisted of 5 groups, including 4 treatment groups with different doses and 1 placebo group.
Subjects used Sublingual Film for Dermatophagoides pteronyssinus or a placebo (a look-alike substance that contains no drug) for approximately 52 weeks, and recorded in E-diary the usage of the investigational product, adverse events, concomitant medications, and the use of rescue medication.
Four efficacy data collection periods (each lasting 4 weeks) were scheduled during the trial: Week 13-16, Week 25-28, Week 37-40, and Week 49-52.
During these efficacy data collection periods, subjects were required to complete E-diary to record rhinitis symptoms (conjunctivitis symptoms were recorded simultaneously for subjects with concurrent conjunctivitis).