Profile of UK patients prescribed Dymista® for Allergic Rhinitis

• Research type

  Research Study

• Full title

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

• IRAS ID

  133403

• Contact name

  Glenis Scadding

• Contact email

  g.scadding@ucl.ac.uk

• Sponsor organisation

  MEDA Pharmaceuticals Limited

• Research summary

  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, multi-centre 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 healthcare professional 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-coded data from 200-250 patients recruited from 20 NHS hospital outpatient clinics (Allergy, Immunology, Ear Nose and Throat clinics).

• REC name

  London - Brent Research Ethics Committee

• REC reference

  13/LO/0917

• Date of REC Opinion

  5 Jul 2013

• REC opinion

  Favourable Opinion