Effectiveness of Dymista® in patients with allergic rhinitis and asthma

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Dymista
• Anatomical Therapeutic Chemical (ATC) code:
  (R01) NASAL PREPARATIONS

  NASAL PREPARATIONS
• Medical condition to be studied:
  Asthma

  Rhinitis allergic

Population studied

• Short description of the study population:
  Asthma patients, aged ≥12 years who initiated Dymista® for treatment of allergic rhinitis.; ; Patients with following criteria were included:; • Initiation of Dymista® (patients receive ≥1 prescription of Dymista® any time); • Diagnosis of asthma ever: diagnostic read code ever following the Quality Outcomes Framework (QOF); • Age ≥12 years at IPD;; • Active asthma, defined as ≥1 prescription for an inhaler (reliever or controller) in the year prior to and including IPD; • Continuous electronic medical data for ≥1 year prior to IPD; • ≥1 year of electronic medical data after IPD
• 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:
  Asthma patients
• Estimated number of subjects:
  1188

Study design details

• Main study objective:
  To examine the effectiveness of Dymista® in terms of improving asthma control by comparing the number of acute respiratory events and other measures of asthma control in the year before and after initiation of Dymista®.
• Outcomes:
  Change in the number of acute respiratory events was defined as occurrence of any of the following events separately or together (occurrences within 14 days of each other were considered to belong to the same event). Change in the number of asthma exacerbations, GINA treatment step, asthma control (Risk Domain Asthma Control and Overall Asthma Control), average daily dose of SABA and control of asthma symptoms (GINA level control)
• Data analysis plan:
  Patients initiating Dymista® were identified. The number of acute respiratory events in the baseline year and outcome year were determined. The effectiveness of Dymista® on the number of acute respiratory events in the baseline year was compared with the number of events in the outcome year by using the Wilcoxon signed rank test (for paired data). The results were reported as the proportion of patients who improved, worsened and stayed stable in the number of, for instance, acute respiratory events.