DYmista NAsal Spray in CHInese Patients
DYNAS-CHI
Multicentre, Randomized, Double-blind, Parallel Group Phase III Study to Assess Efficacy and Safety of Dymista® Compared to Azep® and Flixonase® Nasal Sprays in the Treatment of Chinese Patients With Allergic Rhinitis/Rhinoconjunctivitis
1 other identifier
interventional
900
1 country
33
Brief Summary
This study is a phase III clinical study to assess the efficacy and safety of Dymista® Nasal Spray in comparison to Azep® nasal spray and Flixonase® nasal spray in Chinese patients aged ≥ 12 years with moderate-to-severe allergic rhinitis/rhinoconjunctivitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2018
Shorter than P25 for phase_3
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 29, 2018
CompletedFirst Submitted
Initial submission to the registry
July 17, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 24, 2019
CompletedFebruary 22, 2022
February 1, 2020
1.2 years
July 17, 2018
February 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Combined 12-hour rTNSS (AM + PM)
Total nasal symptom score (TNSSS) is a sum of 4 individual nasal symptom scores: nasal itching, runny nose, congestion and sneezing. Each nasal symptom will be assessed according to a 4-ponit scale (0 = no, 1 = mild, 2 = moderate, 3 = severe symptom); thus, each TNSS will be in the range from 0 (no symptoms at all) to 12 (all 4 symptoms are severe) and the combined 12-hour reflective TNSS (morning + evening) will be in the range of 0 to 24 accordingly
14 days
Study Arms (3)
Azelastine Hydrochl. + Fluticasone Prop.
EXPERIMENTALDrug: Azelastine Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUAT Nasal Spray, consists of a fixed-dose combination of azelastine hydrochloride and fluticasone propionate; 1 spray per nostril twice daily for 14 days, with 3 to 7 days of lead-in period. At a certain point during the study, patients will receive Placebo.
Azelastine hydrochloride
ACTIVE COMPARATORDrug: Azelastine Hydrochloride 0.137 MG/ACTUAT Nasal Spray, 1 spray per nostril twice daily for 14 days, with 3 to 7 days of lead-in period. At a certain point during the study, patients will receive Placebo.
Fluticasone propionate
ACTIVE COMPARATORDrug: Fluticasone Propionate 0.05 MG/ACTUAT Nasal Spray, 1 spray per nostril twice daily for 14 days, with 3 to 7 days of lead-in period. At a certain point during the study, patients will receive Placebo.
Interventions
Dymista Nasal spray suspension
AZEP Nasal spray solution
Fluticasone propionate nasal spray suspension
Eligibility Criteria
You may qualify if:
- To be eligible for enrolment into this study, a patient must comply with all of the following criteria:
- Male or female patient 12 years of age or older.
- Provide written informed consent.
- Patients must have moderate-to-severe rhinitis or rhinoconjunctivitis, defined as rhinitis/rhinoconjunctivitis with one or more of the following being present:
- Sleep disturbance.
- Impairment of daily activities, leisure and/or sport.
- Impairment of learning or work.
- Troublesome symptoms.
- Patients must have moderate-to-severe rhinitis or rhinoconjunctivitis and monotherapy with either intranasal antihistamine or glucocorticoid is not considered sufficient at the discretion of the Investigator and/or designee.
- Conducting the Lead-in Period according to the protocol.
- Willing and able to comply with the study requirements.
- At least a 2-year history of AR (seasonal and/or perennial) during the same time of year as the scheduled study time.
- The presence of Immunoglobulin E (IgE)-mediated hypersensitivity to one or more aeroallergens present in current patient environment, confirmed by a positive response to an established standard diagnostic test at the site within the last year (before randomization).
- General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the Investigator or the sponsor's medical officer. When in doubt, the Investigator should confer with the sponsor's medical monitor or designee to determine eligibility for the study.
- Patient agrees to avoid prohibited medication and alcohol and use effective methods of contraception during the study.
- +1 more criteria
You may not qualify if:
- A patient is ineligible and must not enter the study if any of the following criteria is met:
- Safety concerns:
- Presence of any hypersensitivity to drugs similar to azelastine hydrochloride, fluticasone propionate, or to any of the excipients.
- Women who are pregnant or nursing.
- Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception.
- Clinically significant arrhythmia (or unstable despite medical treatment) or symptomatic cardiac conditions.
- A known history of alcohol or drug abuse within the last 2 years.
- Diagnosis of human immunodeficiency virus (HIV) infection.
- Patients with a diagnosis of Glaucoma, cataract, or central serous chorioretinopathy (CSCR).
- Lack of suitability for the study:
- Nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities (e.g. nasal septum deviation).
- Nasal surgery or sinus surgery within the previous year.
- Chronic sinusitis - more than 3 episodes per year.
- Major malignancies including pheochromocytoma within the last 5 years. Exception will be considered where malignancies have been resolved as judged by Investigator.
- The use of any investigational drug within 30 days prior to Screening Visit. No other investigational products are permitted for use during the conduct of this study.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Investigational Site 2
Beijing, Beijing Municipality, China
Investigational Site 3
Beijing, Beijing Municipality, China
Investigational Site 4
Beijing, Beijing Municipality, China
Investigational Site 5
Beijing, Beijing Municipality, China
Investigational Site
Chongqing, Chonqing, China
Investigational Site 1
Beijing, Dongcheng District, China
Investigational Site 1
Guangzhou, Guangdong, China
Investigational Site 2
Guangzhou, Guangdong, China
Investigational Site 1
Wuhan, Hubei, China
Investigational Site 2
Wuhan, Hubei, China
Investigational Site
Changsha, Hunan, China
Investigational Site
Nanchang, Jiangxi, China
Investigational Site
Changchun, Jilin, China
Investigational Site
Tonghua, Jilin, China
Investigational Site
Yanbian, Jilin, China
Investigational Site
Jining, Jining, China
Investigational Site
Dalian, Liaoning, China
Investigational Site
Nanjing, Nanjing, China
Investigational Site 1
Qingdao, Shandong, China
Investigational Site 2
Qingdao, Shandong, China
Investigational Site
Yantai, Shangdong, China
Investigational Site
Zibo, Shangdong, China
Investigational Site
Shanghai, Shanghai Municipality, China
Investigational Site
Changzhi, Shanxi, China
Investigational Site
Taiyuan, Shanxi, China
Investigational Site 1
Xi’an, Shanxi, China
Investigational Site 2
Xi’an, Shanxi, China
Investigational Site
Chengdu, Sichuan, China
Investigational Site 1
Tianjin, Tianjin Municipality, China
Investigational Site 2
Tianjin, Tianjin Municipality, China
Investigational Site 3
Tianjin, Tianjin Municipality, China
Investigational Site 4
Tianjin, Tianjin Municipality, China
Investigational Site
Ürümqi, Xianjiang Uygur, China
Related Publications (1)
Zhou B, Cheng L, Pan J, Wang H, Jin Y, Zhao C, Lin P, Tan G, Fang H, Zhang H, Zhou H, Dong Y, Kuhl HC, Ramalingam RK, Nguyen DT. A Clinical Study to Assess the Efficacy and Safety of MP-AzeFlu Nasal Spray in Comparison to Commercially Available Azelastine Hydrochloride and Fluticasone Propionate Nasal Sprays in Chinese Volunteers with Allergic Rhinitis. Pulm Ther. 2023 Sep;9(3):411-427. doi: 10.1007/s41030-023-00238-8. Epub 2023 Aug 14.
PMID: 37580498DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
DucTung Nguyen, Dr.
Meda Pharma GmbH & Co. KG (A Mylan Company)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Blinding device
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2018
First Posted
July 26, 2018
Study Start
June 29, 2018
Primary Completion
September 24, 2019
Study Completion
September 24, 2019
Last Updated
February 22, 2022
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share