An observational study in Allergic Rhinitis, sponsored by Mylan Inc.. Completed at 33 sites in 4 countries. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by Mylan Inc. (part of Viatris Inc.) · Observational
Gathering knowledge on the use of Dymista® in Asian patients who receive Dymista® for the first time in routine clinical practice
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:
B) Secondary Objective:
717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.
This study's enrollment of 924 is above the median of 120 across 143 observational studies indexed under Rhinitis, Allergic.
Browse Rhinitis, Allergic studies →Mylan Inc. is the lead sponsor of 44 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 9 (100%) have results posted.
First submitted after Mylan Inc. became part of Viatris Inc..
Counted across the registry records on this site, refreshed daily.
Use of Dymista® in Asian patients (Taiwan, Malaysia, Hongkong and Thailand) with moderate to severe seasonal or perennial allergic rhinitis under real life conditions.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: The duration of the study is approximately 28 days after the eligible patients or caregivers provided the written informed consent
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).
Time frame: 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).
Time frame: 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).
Time frame: From day 1 to day 28
Plan to share: No
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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