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

Study identification

• EU PAS number:
  EUPAS12436
• Study ID:
  25056
• Official title and acronym:
  Drug Utilization Study for Pirinase Hayfever Relief for Adults 0.05% Nasal Spray (205708)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The Medicines and Healthcare products Regulatory Agency (MHRA) has required this study to evaluate consumer compliance with the product labelling of Pirinase Hayfever Relief for Adults 0.05% Nasal Spray over at least 2 allergy seasons. The purpose is to obtain real-world information on how consumers are complying with the product labelling This study will coincide with the launch of Pirinase Hayfever Relief for Adults 0.05% Nasal Spray in the United Kingdom (UK).The 5 primary objectives are:1. To assess if consumers of the correct age use the product: Ages 18 and older2. To assess the correct frequency of use: No more than 2 sprays in each nostril per day3. To assess reduction of dose: If symptoms improve, 1 spray in each nostril per day4. To assess if a physician is consulted before use: if a woman is pregnant or breastfeeding5. To assess if a physician is consulted: If symptoms have not improved after using for 7 days, a doctor is consultedThe 2 secondary objectives are: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
• Study status:
  Finalised

Research institutions and networks

Institutions

Concentrics Research

Study timelines

Date when funding contract was signed

Planned:15/02/2016

Actual:29/01/2016

Study start date

Planned:15/02/2016

Actual:04/04/2016

Date of final study report

Planned:30/09/2018

Actual:19/07/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)