Observational Study to Evaluate the Actual Use and Effectiveness of Dymista® Nasal Spray in Asian Patients
1 other identifier
observational
924
4 countries
33
Brief Summary
Gathering knowledge on the use of Dymista® in Asian patients who receive Dymista® for the first time in routine clinical practice
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
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
First Submitted
Initial submission to the registry
October 26, 2021
CompletedStudy Start
First participant enrolled
October 27, 2021
CompletedFirst Posted
Study publicly available on registry
December 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2023
CompletedNovember 13, 2023
May 1, 2023
2 years
October 26, 2021
November 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Profile of Asian AR patients prescribed with Dymista®
The primary outcome of this non-interventional study is the exploratory description of patient characteristics in regard to demographics, symptoms and allergic rhinitis phenotypes in real life receiving Dymista for the first time.
The duration of the study is approximately 28 days after the eligible patients or caregivers provided the written informed consent
Secondary Outcomes (3)
Effectiveness of Dymista® in Asian AR patients (Symptom Severity Assessment by VAS)
From day 1 to day 28
Effectiveness of Dymista® in Asian AR patients (QOL assessment by VAS)
From day 1 to day 28
Effectiveness of Dymista® in Asian AR patients (Impact on daily activities assessment by VAS)
From day 1 to day 28
Study Arms (1)
Dymista®
Dymista® (Azelastine hydrochloride and Fluticasone propionate) nasal spray as prescribed within routine clinical practice
Interventions
Eligibility Criteria
Use of Dymista® in Asian patients (Taiwan, Malaysia, Hongkong and Thailand) with moderate to severe seasonal or perennial allergic rhinitis under real life conditions.
You may qualify if:
- The first prescription of Dymista® nasal spray according to the summary of product characteristics (SPC) and patient information leaflet and independently from the patient's enrollment in the study.
- Patients with moderate to severe seasonal or perennial allergic rhinitis
- For Hong Kong and Malaysia: Adult and children of age ≥ 12 years
- For Taiwan: Adult and children of age ≥ 6 years.
- For Thailand: Adults and children of age ≥ 12 years with seasonal and/or perennial allergic rhinitis OR children of age 6-11 years with only seasonal allergic rhinitis
- Signed informed consent/assent from the patient and, if applicable, the parent(s) or legal guardian(s) in compliance with local requirements.
- Ability to understand and follow the instructions for using Dymista® nasal spray according to the patient information leaflet.
- Willingness to complete and return the Patient Card.
You may not qualify if:
- Known allergic reaction from and/or intolerance to Dymista® nasal spray or any of the ingredients.
- Pregnancy/planned pregnancy or breastfeeding during this NIS
- Patients or parent(s)/legal guardians (as applicable) not able to fulfill study requirements according to the Investigator's opinion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mylan Inc.lead
- MEDA Pharma GmbH & Co. KGcollaborator
Study Sites (33)
Hong Kong ENT Clinic
Hong Kong, Hong Kong
Asia Priority Healthcare
Kowloon, Hong Kong
Kempas Medical Center
Johor Bahru, Malaysia
KPJ Johor Specialist Hospital
Johor Bahru, Malaysia
Allergy and Immunology Clinic Gleneagles Kuala Lumpur
Kuala Lumpur, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Hospital Universiti Sains Malaysia
Kubang Kerian, Malaysia
Sarawak General Hospital
Kuching, Malaysia
Pantai Hospital Ipoh
Perai, 31400, Malaysia
Hospital Sultan Abdul Aziz Shah
Serdang, Malaysia
St. Martin De Porres Hospital
Chiayi City, Taiwan
Chang Gung Memorial Hospital-KAOHSIUNG
Kaohsiung City, Taiwan
Asia University Hospital
Taichung, Taiwan
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Taipei Municipal Wan Fang Hospital
Taipei, Taiwan
China Medical University Hsinchu Hospital
Zhubei, Taiwan
Bangkok hospital
Bangkok, Thailand
King Chulalongkorn Memorial Hospital (Department of Medicine)
Bangkok, Thailand
King Chulalongkorn Memorial Hospital (Department of Pediatrics)
Bangkok, Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Phramongkutklao Hospital
Bangkok, Thailand
Rajavithi Hospital
Bangkok, Thailand
Ramathibodi hospital
Bangkok, Thailand
Siriraj Hospital (Department of Medicine)
Bangkok, Thailand
Siriraj Hospital (Department of Otorhinolaryngology)
Bangkok, Thailand
Thammasat University Hospital (Department of Otolaryngology)
Bangkok, Thailand
Thammasat University Hospital (Department of Pediatrics)
Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand
Naresuan University Hospital
Phitsanulok, Thailand
Songkla University Hospital
Songkhla, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2021
First Posted
December 15, 2021
Study Start
October 27, 2021
Primary Completion
October 24, 2023
Study Completion
October 24, 2023
Last Updated
November 13, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share