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

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Combined primary data collection and secondary use of data

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  AZELASTINE HYDROCHLORIDE

  FLUTICASONE PROPIONATE
• Medical condition to be studied:
  Rhinitis allergic

Population studied

• Short description of the study population:
  Rhinitis allergic patients that have been prescribed Dymista® by UK specialists
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Rhinitis allergic patients
• Estimated number of subjects:
  250

Study design details

• Main study objective:
  To understand the demographic characteristics, medical and treatment history of the population of patients that have been prescribed Dymista® in routine UK NHS secondary/tertiary care, in order to inform future strategies for the management and treatment of allergic rhinitis. This information is also thought to be of interest to NHS commissioners, in order to understand the impact on NHS services.
• Outcomes:
  To describe the clinical indications for which Dymista® has been prescribed in UK clinical practice, To describe the: demographic characteristics of patients receiving Dymista® for allergic rhinitis (AR) in UK clinical practice, reasons for prescribing Dymista®, AR symptoms experienced when Dymista® is prescribed, impact of AR on daily patient life at initiation of Dymista®, all previous treatments prescribed for AR, and number of visits to a HCP in the last year, prior to starting Dymista®
• Data analysis plan:
  Data relating to participating centres in the UK will be descriptive in nature. Both distributions and descriptive statistics of both central tendency (medians and arithmetic or geometric means) and dispersion (standard deviation, interquartile range) will be presented for quantitative variables. Nominal variables will be described with frequencies, percentages and modes, while ordinal variables will also have medians and interquartile ranges described. Confidence intervals will be provided for proportions of nominal variables and for means of quantitative variables.Analyses will be performed using the available data. No attempt will be made to impute missing values.