Observational Study to Evaluate the Actual Use and Effectiveness of Dymista® Nasal Spray in Asian Patients
Study Details
Study Description
Brief Summary
Gathering knowledge on the use of Dymista® in Asian patients who receive Dymista® for the first time in routine clinical practice
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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:
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allergic and other comorbidities
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allergic conjunctivitis
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polysensitization
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current symptoms
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previous treatments of allergic rhinitis
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usage of current asthma reliever medication
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family history of allergy
B) Secondary Objective:
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Response to therapy with Dymista® nasal spray in routine clinical practice.
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Quality of sleep (by VAS)
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Troublesomeness in daily activities (by VAS)
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Patient's assessment about the regular use of Dymista®
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Patients opinion about continuation of Dymista® treatment after end of the observational period
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Profile of Asian AR patients prescribed with Dymista® [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 Outcome Measures
- Effectiveness of Dymista® in Asian AR patients [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).
- Effectiveness of Dymista® in Asian AR patients [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).
- Effectiveness of Dymista® in Asian AR patients [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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Patients with moderate to severe seasonal or perennial allergic rhinitis
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For Hong Kong and Malaysia: Adult and children of age ≥ 12 years
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For Taiwan: Adult and children of age ≥ 6 years.
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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
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Acute allergic rhinitis symptoms at the day of inclusion (i.e. VAS-Score ≥50 mm)
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Signed informed consent/assent from the patient and, if applicable, the parent(s) or legal guardian(s) in compliance with local requirements.
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Ability to understand and follow the instructions for using Dymista® nasal spray according to the patient information leaflet.
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Willingness to complete and return the Patient Card.
Exclusion Criteria:
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VAS score <50 mm on day of inclusion
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Known allergic reaction from and/or intolerance to Dymista® nasal spray or any of the ingredients.
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Pregnancy/planned pregnancy or breastfeeding during this NIS
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Patients or parent(s)/legal guardians (as applicable) not able to fulfill study requirements according to the Investigator's opinion.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Asia Priority Healthcare | Kowloon | Hong Kong | ||
| 2 | Kempas Medical Center | Johor Bahru | Malaysia | ||
| 3 | KPJ Johor Specialist Hospital | Johor Bahru | Malaysia | ||
| 4 | Gleneagles Kuala Lumpur | Kuala Lumpur | Malaysia | ||
| 5 | Hospital Universiti Sains Malaysia | Kubang Kerian | Malaysia | ||
| 6 | Sarawak General Hospital | Kuching | Malaysia | ||
| 7 | KPJ Ipoh Specialist Hospital | Perai | Malaysia | ||
| 8 | Pantai Hospital Ipoh | Perai | Malaysia | ||
| 9 | Hospital Pengajar Universiti Putra Malaysia | Serdang | Malaysia | ||
| 10 | St. Martin De Porres Hospital | Chiayi City | Taiwan | ||
| 11 | Chang Gung Memorial Hospital-KAOHSIUNG | Kaohsiung | Taiwan | ||
| 12 | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung | Taiwan | ||
| 13 | Asia University Hospital | Taichung | Taiwan | ||
| 14 | Taichung Veterans General Hospital | Taichung | Taiwan | ||
| 15 | National Taiwan University Hospital | Taipei | Taiwan | ||
| 16 | Bangkok hospital | Bangkok | Thailand | ||
| 17 | King chula memorial hospital | Bangkok | Thailand | ||
| 18 | King chula memorial hospital | Bangkok | Thailand | ||
| 19 | King chula memorial hospital | Bangkok | Thailand | ||
| 20 | Phramongkutklao Hospital | Bangkok | Thailand | ||
| 21 | Rajavithi Hospital | Bangkok | Thailand | ||
| 22 | Ramathibodi hospital | Bangkok | Thailand | ||
| 23 | Siriraj hospital | Bangkok | Thailand | ||
| 24 | Siriraj hospital | Bangkok | Thailand | ||
| 25 | Thammasat University Hospital | Bangkok | Thailand | ||
| 26 | Thammasat | Bangkok | Thailand | ||
| 27 | Vajira | Bangkok | Thailand |
Sponsors and Collaborators
- Mylan Inc.
- MEDA Pharma GmbH & Co. KG
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3325