Observational Study to Evaluate the Actual Use and Effectiveness of Dymista® Nasal Spray in Asian Patients

Allergic Rhinitis Clinical Trial

Official title:

Observational Study to Evaluate the Actual Use and Effectiveness of Dymista® Nasal Spray in Asian Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05158972
• Other study ID #: 3325
• Status: Completed
• Start date: October 27, 2021
• Est. completion date: October 24, 2023

Study information

• Verified date: May 2023
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Gathering knowledge on the use of Dymista® in Asian patients who receive Dymista® for the first time in routine clinical practice

Description:

A) Primary objective: Gathering knowledge on the use of Dymista® in Asian patients who receive Dymista® for the first time in routine clinical practice; Patient's demographic; Anamnestic background including: - allergic and other comorbidities - allergic conjunctivitis - polysensitization - current symptoms - previous treatments of allergic rhinitis - usage of current asthma reliever medication - family history of allergy B) Secondary Objective: - Response to therapy with Dymista® nasal spray in routine clinical practice. - Quality of sleep (by VAS) - Troublesomeness in daily activities (by VAS) - Patient's assessment about the regular use of Dymista® - Patients opinion about continuation of Dymista® treatment after end of the observational period

Recruitment information / eligibility

• Status: Completed
• Enrollment: 924
• Est. completion date: October 24, 2023
• Est. primary completion date: October 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• 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
• Acute allergic rhinitis symptoms at the day of inclusion (i.e. VAS-Score =50 mm)
• 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.

Exclusion Criteria:

• VAS score <50 mm on day of inclusion
• 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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Dymista
1 spray per nostril twice daily up to four weeks

Locations

Country	Name	City	State
Hong Kong	Hong Kong ENT Clinic	Hong Kong
Hong Kong	Asia Priority Healthcare	Kowloon
Malaysia	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
Malaysia	Hospital Sultan Abdul Aziz Shah	Serdang
Taiwan	St. Martin De Porres Hospital	Chiayi City
Taiwan	Chang Gung Memorial Hospital-KAOHSIUNG	Kaohsiung
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
Thailand	Bangkok hospital	Bangkok
Thailand	King Chulalongkorn Memorial Hospital	Bangkok
Thailand	King Chulalongkorn Memorial Hospital (Department of Medicine)	Bangkok
Thailand	King Chulalongkorn Memorial Hospital (Department of Pediatrics)	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

Sponsors (2)

Lead Sponsor	Collaborator
Mylan Inc.	MEDA Pharma GmbH & Co. KG

Countries where clinical trial is conducted

Hong Kong,  Malaysia,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Effectiveness of Dymista® in Asian AR patients (Symptom Severity Assessment by VAS)	Response to treatment would be assessed by self-reported severity of symptoms (change of Visual Analog Score). The visual analog scale titled as "Please reflect how much bothersome your OVERALL allergic rhinitis symptoms were within the previous 24 hours" This will be done by marking with a pen the printed visual analog scale over the patient card at the appropriate range (not at all bothersome / troubled = 0 to extremely bothersome / troubled = 100 mm).	From day 1 to day 28
Secondary	Effectiveness of Dymista® in Asian AR patients (QOL assessment by VAS)	Sleep change will be assessed by self-reported quality of sleep (change of Visual Analog Score). The visual analog scale titled as "Please reflect how troubled you have been by lack of good night sleep during the previous 7 days as a result of your allergic rhinitis symptoms." This will be done by marking with a pen the printed visual analog scale over the patient card at the appropriate range (not at all bothersome / troubled = 0 to extremely bothersome / troubled = 100 mm).	From day 1 to day 28
Secondary	Effectiveness of Dymista® in Asian AR patients (Impact on daily activities assessment by VAS)	Impact on daily activities will be assessed by self-reported troubles in daily activities (change of Visual Analog Score). The visual analog scale titled as "Please reflect how troubled you have been by the following activities (Regular activities at home and work / school, Social activities, Outdoor activities) during the previous 7 days as a result of your allergic rhinitis symptoms".; For each of these activities, it will be done by marking with a pen the printed visual analog scale over the patient card at the appropriate range (not at all bothersome / troubled = 0 to extremely bothersome / troubled = 100 mm).	From day 1 to day 28