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

NCT ID: NCT05158972

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 924 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-27
• Study Completion Date: 2023-10-24

Brief Summary

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

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

Conditions

Allergic Rhinitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Dymista®

Dymista® (Azelastine hydrochloride and Fluticasone propionate) nasal spray as prescribed within routine clinical practice

Dymista

Intervention Type: DRUG

1 spray per nostril twice daily up to four weeks

Interventions

Dymista

1 spray per nostril twice daily up to four weeks

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MEDA Pharma GmbH & Co. KG

INDUSTRY

Sponsor Role: collaborator

Mylan Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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, , 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

Countries

Hong Kong; Malaysia; Taiwan; Thailand

Other Identifiers

3325

Identifier Type: -

Identifier Source: org_study_id