Observational study on persistent allergic rhinitis patients to evaluate effectiveness of Dymista® nasal spray in daily practice

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-interventional study

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:
  Patients with Persistent Allergic Rhinitis assessed by means of a Visual Analogue Scale (VAS) recieving Dymista® nasal spray in routine clinical practice.
• 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:
  428

Study design details

• Main study objective:
  To gather knowledge on the effectiveness of Dymista® nasal spray in routine clinical practice in patients with persistent allergic Rhinitis assessed by means of a Visual Analogue Scale (VAS) and sleep quality.
• Data analysis plan:
  Descriptive statistics (frequency tables, number, mean, Standard deviation, minimum, 5% percentile, lower quartile, median, upper quartile, 95% percentile, and maximum). Baseline adjusted Analysis of Covariance (ANCOVA) for repeated measurements with factor day for analysis of change over time (exploratory).