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

Mylan

Status

Completed

Conditions

Allergic Rhinitis

Treatments

Drug: Dymista

Study type

Observational

Funder types

Industry

Identifiers

NCT05158972

3325

Details and patient eligibility

About

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

Full 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

Enrollment

924 patients

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

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.