Clinical trial NCT05158972: Observational Study to Evaluate the Actual Use and Effectiveness of Dymista® Nasal Spray in Asian Patients
Official title: Observational Study to Evaluate the Actual Use and Effectiveness of Dymista® Nasal Spray in Asian Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: MEDA Pharma GmbH & Co. KG
First posted: 2021-12-15
Enrollment: 924
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Primary outcomes:
measure: Profile of Asian AR patients prescribed with Dymista®
timeFrame: The duration of the study is approximately 28 days after the eligible patients or caregivers provided the written informed consent
Secondary outcomes:
measure: Effectiveness of Dymista® in Asian AR patients (Symptom Severity Assessment by VAS)
timeFrame: From day 1 to day 28
measure: Effectiveness of Dymista® in Asian AR patients (QOL assessment by VAS)
timeFrame: From day 1 to day 28
measure: Effectiveness of Dymista® in Asian AR patients (Impact on daily activities assessment by VAS)
timeFrame: From day 1 to day 28
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong ENT Clinic
city: Kowloon
country: Hong Kong
facility: Asia Priority Healthcare
city: Johor Bahru
country: Malaysia
facility: Kempas Medical Center
city: Johor Bahru
country: Malaysia
facility: KPJ Johor Specialist Hospital
city: Kuala Lumpur
country: Malaysia
facility: Allergy and Immunology Clinic Gleneagles Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Kubang Kerian
country: Malaysia
facility: Hospital Universiti Sains Malaysia
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
city: Perai
country: Malaysia
facility: Pantai Hospital Ipoh
city: Serdang
country: Malaysia
facility: Hospital Sultan Abdul Aziz Shah
city: Chiayi City
country: Taiwan
facility: St. Martin De Porres Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital-KAOHSIUNG
city: Taichung
country: Taiwan
facility: Asia University Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Municipal Wan Fang Hospital
city: Zhubei
country: Taiwan
facility: China Medical University Hsinchu Hospital
city: Bangkok
country: Thailand
facility: Bangkok hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital (Department of Medicine)
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital (Department of Pediatrics)
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital (Department of Medicine)
city: Bangkok
country: Thailand
facility: Siriraj Hospital (Department of Otorhinolaryngology)
city: Bangkok
country: Thailand
facility: Thammasat University Hospital (Department of Otolaryngology)
city: Bangkok
country: Thailand
facility: Thammasat University Hospital (Department of Pediatrics)
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
city: Phitsanulok
country: Thailand
facility: Naresuan University Hospital
city: Songkhla
country: Thailand
facility: Songkla University Hospital
Study officials:
References: