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Completed

NCT Number: NCT05158972

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

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hong Kong ENT Clinic, Hong Kong

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dymista

Drug

1 spray per nostril twice daily up to four weeks

Primary outcomes

  1. Profile of Asian AR patients prescribed with Dymista®

    Time frame: The duration of the study is approximately 28 days after the eligible patients or caregivers provided the written informed consent

    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.

Secondary outcomes

  1. Effectiveness of Dymista® in Asian AR patients (Symptom Severity Assessment by VAS)

    Time frame: From day 1 to day 28

    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).

  2. Effectiveness of Dymista® in Asian AR patients (QOL assessment by VAS)

    Time frame: From day 1 to day 28

    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).

  3. Effectiveness of Dymista® in Asian AR patients (Impact on daily activities assessment by VAS)

    Time frame: From day 1 to day 28

    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).

Sponsors and collaborators

Lead sponsor

Mylan Inc.

Industry

Collaborators

  • MEDA Pharma GmbH & Co. KG

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 15, 2021
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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