Retrospective Case‐Control Studies of Rare Adverse Events Associated with Intranasal Steroids (201077)

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
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective Nested Case Controlled study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  FLUTICASONE FUROATE

  FLUTICASONE PROPIONATE
• Medical condition to be studied:
  Glaucoma

  Ocular hypertension

  Cataract

  Adrenal insufficiency

  Glucocorticoid deficiency

Population studied

• Short description of the study population:
  Individuals continuously enrolled in the IMS database with both medical and pharmacy claims for at least 1 year in the IMS database.
• 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)
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  To determine risk ratios of corticosteroid treatment for case reports of cataracts and glaucoma associated with prescription intranasal corticosteroid use and to determine the odds ratios for developing adrenal insufficiency after discontinuation of intranasal steroids or intranasal fluticasone, with a focus on intranasal fluticasone use.
• Outcomes:
  The purpose of this research is to explore putative associations between exposure to intranasal steroids and the subsequent development of glaucoma, cataract or adrenal insufficiency
• Data analysis plan:
  The goals of this study will be to determine the odds ratios for developing glaucoma or cataract in relation to recent and length of exposure to intranasal steroid or intranasal fluticasone, and to determine the odds ratio for developing adrenal Insufficiency after discontinuation of intranasal steroids or intranasal fluticasone.

Documents

Study results

UCSFreport_NestedCC_INS_Glau-Cat-AI_MAY23-2014_ver1-4