Overview
A research study of house dust mite (HDM) SLIT-tablet for the treatment of HDM allergy in Chinese participants aged 12-65.
Description
The trial aims to evaluate efficacy of the house dust mite (HDM) SLIT-tablet compared to placebo in Chinese participants aged 12-65 with HDM allergic rhinitis/rhinoconjunctivitis with or without asthma. Efficacy will be assessed based on the total combined rhinitis score during the last 4 weeks of treatment.
The trial is a randomised, double-blind, parallel-group, placebo-controlled, multi-site, phase III trial conducted in China. The treatment period will be 24-28 weeks.
Eligibility
Inclusion Criteria:
- Male or female Chinese subjects aged 12-65 years
- A clinical history of HDM AR/C (Allergic rhinitis/rhinoconjunctivitis) (with or without asthma) and with allergic rhinitis symptoms despite having received allergy pharmacotherapy during the previous year prior to screening
- Have a certain level of AR (Allergic rhinitis) symptoms on at least 8 of the last 14 days of the baseline period
- Use symptomatic medication for treatment of HDM allergic rhinitis during at least 8 of the last 14 days of the baseline period
- Positive skin prick test (SPT) and IgE (Immunoglobulin E) to D. pteronyssinus or D. farinae at screening
- Lung function ≥ 70% of predicted value
Exclusion Criteria:
- Sensitised and regularly exposed to perennial allergens
- Any nasal or pharyngeal condition that could interfere with the safety or efficacy evaluation
- Asthma requiring treatment with high dose of inhaled corticosteroid
- A relevant history of systemic allergic reaction