Drug Utilization Study for Pirinase Hayfever Relief for Adults 0.05% Nasal Spray (205708)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Not applicable
• If ‘Not applicable’, further details on the study type:
  Online consumer survey for people who have purchased and used the product.

Study drug and medical condition

• Medicinal product name, other:
  Fluticasone propionate
• Medical condition to be studied:
  Rhinitis allergic

Population studied

• Short description of the study population:
  Approximately 1537 consumers in the UK who have purchased and used Pirinase Hayfever Relief for Adults 0.05% Nasal Spray for at least 7 days.
• Age groups:
  • Children (2 to < 12 years)
  • 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:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  1537

Study design details

• Main study objective:
  The primary objective of this study is to evaluate if consumers comply with key warnings and directions on the outer label for selection and use of the drug.
• Outcomes:
  To assess:- if consumers of the correct age use the product: (18 and older)- the correct frequency of use: No more than 2 sprays in each nostril/day- reduction of dose: If symptoms improve, 1 spray in each nostril/day- if a physician is consulted before use: if a woman is pregnant or breastfeeding- if a physician is consulted: If symptoms have not improved after using for 7 days, The two secondary objectives are the following:1. To assess if consumers do not use if they are taking medications for Human Immunodeficiency Virus (HIV)2. To assess if a physician is consulted: Not used more than 1 month continuously without consulting a doctor
• Data analysis plan:
  Primary endpoints will be analyzed individually and no adjustment for multiple comparisons will be performed. The compliance rate for each of the five primary endpoints will be reported and its two-sided 95% confidence limit will be computed using the exact method. The endpoint will have met the threshold for success if the lower bound of the 2-sided 95% exact confidence interval (CI) is at least 80%. Secondary endpoints will be analyzed individually and no adjustment for multiple comparisons will be performed. The compliance rate for each of the secondary endpoints will be reported and its two-sided 95% confidence limit will be computed using the exact method. There are no success thresholds set for secondary endpoints.