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

November 10, 2023 updated by: Mylan Inc.
Gathering knowledge on the use of Dymista® in Asian patients who receive Dymista® for the first time in routine clinical practice

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
924

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
The duration of the study is approximately 28 days after the eligible patients or caregivers provided the written informed consent

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
From day 1 to day 28
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).
From day 1 to day 28
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).
From day 1 to day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mylan Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
MEDA Pharma GmbH & Co. KG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 24, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 24, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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