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RECRUITINGPhase 3INTERVENTIONAL

A Research Study of House Dust Mite (HDM) SLIT-tablet for the Treatment of HDM Allergy in Chinese Participants Aged 12-65

A Randomised Double-blind Placebo-controlled Phase III Field Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) SLIT-tablet in Chinese Participants Aged 12-65 Years With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

A research study of house dust mite (HDM) SLIT-tablet for the treatment of HDM allergy in Chinese participants aged 12-65.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BIOLOGICAL

HDM SLIT-tablet (12 SQ-HDM)

For daily administration (1 tablet per day) Other Names: Acarizax, Odactra

OTHER

Placebo

For daily administration (1 tablet per day)

Locations (20)

Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
The first hospital affiliated Fujian medical University
Fuzhou, Fujian, China
The first affiliated hospital of guangzhou medical university-respiratory department
Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Third Affilliated Hospital of Southern Medical University
Guangzhou, Guangdong, China
Shenzhen Children's Hospital - Respiratory
Shenzhen, Guangdong, China
Huazhong University of science and Technology Union Shenzhen Hospital(Nanshan Hospital) - Endocrinology
Shenzhen, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-Sen University - University Hospital
Zhuhai, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The People's Hospital of Guangxi Zhuang Autonomous Region - Nephrology - Oncology
Nanning, Guangxi, China
Hainan General Hospital - Respiratory
Haikou, Hainan, China
The Third Hospital of Changsha - Pulmonology
Changshacun, Henan, China
The First Affiliated Hospital of University of South China - Endocrinology
Hengyang, Henan, China
Jingzhou Central Hospital - Otorhinolaryngology
Jingzhou, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology - Oncology
Wuhan, Hubei, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
Jiangsu Province Hospital/ The First Affiliated Hospital with Nanjing Medical University - Otorhinolaryngology
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University - Respiratory
Suzhou, Jiangsu, China
Nanchang University - The First Affiliated Hospital
Nanchang, Jiangxi, China