Allergic RhinitisNCT05158972
Observational Study to Evaluate the Actual Use and Effectiveness of Dymista® Nasal Spray in Asian Patients
An observational study of Allergic Rhinitis, run by Mylan Inc. at 33 sites in 4 countries.
Trial summary
Gathering knowledge on the use of Dymista® in Asian patients who receive Dymista® for the first time in routine clinical practice Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Dymista
- How many people
- 924 participants
- Where
- 33 sitesin 4 countries
- Study dates
- 27 Oct 2021to 24 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
33 sites in 4 countries.
33 sites in 4 countries
Thailand14 sites
Bangkok hospital
Bangkok
King Chulalongkorn Memorial Hospital (Department of Medicine)
Bangkok
King Chulalongkorn Memorial Hospital (Department of Pediatrics)
Bangkok
King Chulalongkorn Memorial Hospital
Bangkok
Phramongkutklao Hospital
Bangkok
Rajavithi Hospital
Bangkok
Ramathibodi hospital
Bangkok
Siriraj Hospital (Department of Medicine)
Bangkok
Siriraj Hospital (Department of Otorhinolaryngology)
Bangkok
Thammasat University Hospital (Department of Otolaryngology)
Bangkok
Thammasat University Hospital (Department of Pediatrics)
Bangkok
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai
Naresuan University Hospital
Phitsanulok
Songkla University Hospital
Songkhla
Taiwan9 sites
St. Martin De Porres Hospital
Chiayi City
Chang Gung Memorial Hospital-KAOHSIUNG
Kaohsiung City
Asia University Hospital
Taichung
China Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
National Taiwan University Hospital
Taipei
Taipei Medical University Hospital
Taipei
Taipei Municipal Wan Fang Hospital
Taipei
China Medical University Hsinchu Hospital
Zhubei
Malaysia8 sites
Kempas Medical Center
Johor Bahru
KPJ Johor Specialist Hospital
Johor Bahru
Allergy and Immunology Clinic Gleneagles Kuala Lumpur
Kuala Lumpur
University Malaya Medical Centre
Kuala Lumpur
Hospital Universiti Sains Malaysia
Kubang Kerian
Sarawak General Hospital
Kuching
Pantai Hospital Ipoh
Perai, 31400
Hospital Sultan Abdul Aziz Shah
Serdang
Hong Kong2 sites
Hong Kong ENT Clinic
Hong Kong
Asia Priority Healthcare
Kowloon
About this study
Gathering knowledge on the use of Dymista® in Asian patients who receive Dymista® for the first time in routine clinical practice
Read the detailed description
- 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
- 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
- Being tested
- Dymista
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DymistaDrug
1 spray per nostril twice daily up to four weeks
| Study group | Role | What they receive |
|---|---|---|
| Dymista® | Dymista® (Azelastine hydrochloride and Fluticasone propionate) nasal spray as prescribed within routine clinical practice Receives: Drug: Dymista |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile of Asian AR patients prescribed with Dymista®
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.
Measured: The duration of the study is approximately 28 days after the eligible patients or caregivers provided the written informed consent
Secondary outcomes (3)
Effectiveness of Dymista® in Asian AR patients (Symptom Severity Assessment by VAS)
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).
Measured: From day 1 to day 28
Effectiveness of Dymista® in Asian AR patients (QOL assessment by VAS)
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).
Measured: From day 1 to day 28
Effectiveness of Dymista® in Asian AR patients (Impact on daily activities assessment by VAS)
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).
Measured: From day 1 to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start27 Oct 2021
- Primary completion24 Oct 2023
- Study completion24 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 924 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MEDA Pharma GmbH & Co. KG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158972
- Sponsor's protocol ID
- 3325
- Status last verified
- May 2023
- First submitted
- 26 Oct 2021
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate the Actual Use and Effectiveness of Dymista® Nasal Spray in Asian Patients
- ClinicalTrials.gov ID
- NCT05158972
- Acronym / sponsor ID
- 3325
- Conditions
- Allergic Rhinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 924 participants (actual)
- Lead sponsor
- Mylan Inc.Industry (pharma, biotech, devices)
- Collaborators
- MEDA Pharma GmbH & Co. KG
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 24 Oct 2023 (actual)
- Study completion
- 24 Oct 2023 (actual)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gathering knowledge on the use of Dymista® in Asian patients who receive Dymista® for the first time in routine clinical practice
Detailed description
- 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
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dymista® | – | Drug: DymistaDymista® (Azelastine hydrochloride and Fluticasone propionate) nasal spray as prescribed within routine clinical practice |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dymista1 spray per nostril twice daily up to four weeks | Drug | Dymista® |
Primary outcome
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.
3 secondary outcomes
Effectiveness of Dymista® in Asian AR patients (Symptom Severity Assessment by VAS)
Time frame: 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
Effectiveness of Dymista® in Asian AR patients (Impact on daily activities assessment by VAS)
Time frame: From day 1 to day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis, run by Mylan Inc. at 33 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Thailand, Taiwan, Malaysia, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.