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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/15565
• EU PAS number:
  EUPAS5049
• Study ID:
  15565
• Official title and acronym:
  Retrospective Case‐Control Studies of Rare Adverse Events Associated with Intranasal Steroids (201077)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  GSK Consumer Healthcare has funded an investigator-sponsored retrospective epidemiological study analyzing medical-pharmacy claims to determine odds ratios for developing glaucoma or cataract in relation totiming and duration of exposure to an intranasal steroid or intranasal fluticasone, and to determine the odds ratio for developing adrenal insufficiency after discontinuation of intranasal steroids or intranasal fluticasone.
• Study status:
  Finalised

Research institution and networks

Institutions

University of California

Study timelines

Date when funding contract was signed

Planned: 12/05/2012

Actual: 25/05/2012

Study start date

Planned: 15/09/2012

Actual: 15/09/2012

Data analysis start date

Planned: 15/09/2012

Actual: 15/09/2012

Date of final study report

Planned: 30/05/2014

Actual: 23/05/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

Case Study Redact_201077

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)