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

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

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: Dymista

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 924

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Hong Kong ENT Clinic
  • Kowloon, Hong Kong
    • Asia Priority Healthcare
• Malaysia
  • Johor Bahru, Malaysia
    • Kempas Medical Center
  • Johor Bahru, Malaysia
    • KPJ Johor Specialist Hospital
  • Kuala Lumpur, Malaysia
    • University Malaya Medical Centre
  • Kuala Lumpur, Malaysia
    • Allergy and Immunology Clinic Gleneagles Kuala Lumpur
  • Kubang Kerian, Malaysia
    • Hospital Universiti Sains Malaysia
  • Kuching, Malaysia
    • Sarawak General Hospital
  • Perai, Malaysia, 31400
    • Pantai Hospital Ipoh
  • Serdang, Malaysia
    • Hospital Sultan Abdul Aziz Shah
• Taiwan
  • Chiayi City, Taiwan
    • St. Martin De Porres Hospital
  • Kaohsiung, Taiwan
    • Chang Gung Memorial Hospital-Kaohsiung
  • Taichung, Taiwan
    • China Medical University Hospital
  • Taichung, Taiwan
    • Taichung Veterans General Hospital
  • Taichung, Taiwan
    • Asia University Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital
  • Taipei, Taiwan
    • Taipei Medical University Hospital
  • Taipei, Taiwan
    • Taipei Municipal Wan Fang Hospital
  • Zhubei, Taiwan
    • China Medical University Hsinchu Hospital
• Thailand
  • Bangkok, Thailand
    • Rajavithi hospital
  • Bangkok, Thailand
    • Ramathibodi Hospital
  • Bangkok, Thailand
    • King Chulalongkorn Memorial Hospital
  • Bangkok, Thailand
    • Phramongkutklao Hospital
  • Bangkok, Thailand
    • Bangkok hospital
  • Bangkok, Thailand
    • King Chulalongkorn Memorial Hospital (Department of Medicine)
  • Bangkok, Thailand
    • King Chulalongkorn Memorial Hospital (Department of Pediatrics)
  • 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)
  • Chiang Mai, Thailand
    • Maharaj Nakorn Chiang Mai Hospital
  • Phitsanulok, Thailand
    • Naresuan University Hospital
  • Songkhla, Thailand
    • Songkla University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Use of Dymista® in Asian patients (Taiwan, Malaysia, Hongkong and Thailand) with moderate to severe seasonal or perennial allergic rhinitis under real life conditions.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dymista®; Dymista® (Azelastine hydrochloride and Fluticasone propionate) nasal spray as prescribed within routine clinical practice	Drug: Dymista; 1 spray per nostril twice daily up to four weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Mylan Inc.
• Collaborators: MEDA Pharma GmbH & Co. KG

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Actual): October 24, 2023
• Study Completion (Actual): October 24, 2023

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: 3325

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No