Study identification

PURI

https://redirect.ema.europa.eu/resource/15022

EU PAS number

EUPAS4414

Study ID

15022

Official title and acronym

Profile of patients prescribed Dymista® (azelastine hydrochloride/ fluticasone propionate) nasal spray for allergic rhinitis in the UK

DARWIN EU® study

No

Study countries

Denmark
Germany
Norway
Sweden

Study description

Dymista® is a nasal spray containing a mixture of an antihistamine and a corticosteroid, which is approved in the UK for the treatment of allergic rhinitis (AR) (hay fever and year round allergy). Evidence of its efficacy and tolerability obtained during the regulatory clinical development process has been generated within the constraints of randomised clinical trials with tightly defined patient inclusion criteria. However there have been no studies on the use of Dymista® by patients in the real world clinical setting in the UK.The aim of this study is to understand the demographic characteristics, medical and treatment history of the population of patients that have been prescribed Dymista® by UK specialists, in routine NHS secondary/tertiary care environment in order to inform future strategies for the management and treatment of allergic rhinitis. This study is the UK arm of an international, multicentre study being conducted in several countries in Europe with the aim of including 7,000 patients in total.The study will involve collecting data from patients' medical records (patient’s clinical characteristics, predominant symptom, reasons for the patient visit and prescribing Dymista® and previous prescribed medications for AR) and completion of a short questionnaire by patients themselves (number of visits by the patient to a healthcareprofessional in the last year, impact of AR on quality of life, presence of eye symptoms and previous treatment history prescribed and self-medication). In the UK, the study will include anonymised codeddata from 200-250 patients recruited from 20 NHS hospital outpatient clinics (Allergy, Immunology, Ear Nose and Throat clinics).

Study status

Finalised
Research institutions and networks

Institutions

University College London Hospitals NHS Foundation Trust
University Hospital of Wales cardiff, Royal Albert Edward Infirmary Wigan, Royal Victoria Hospital Belfast, Wrexham Maelor Hospital Wrexham, Royal Surrey County Hospita Guildford, Royal Hallamshire Hospital Sheffield, Northern General Hospital Sheffield, Cumberland Infirmary Carlisle, North Devon District Hospital Barnstaple, James Paget University Hospital Great Yarmouth

Contact details

Glenis Scadding

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

MEDA Pharmaceuticals Ltd
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable