Inhaler adherence and time to GINA step 5 therapy in a real-life moderate to severe asthma population

Study identification

• EU PAS number:
  EUPAS28437
• Study ID:
  33037
• Official title and acronym:
  Inhaler adherence and time to GINA step 5 therapy in a real-life moderate to severe asthma population
• DARWIN EU® study:
  No
• Study countries:
  Australia
• Study description:
  According to the international GINA guidelines for asthma, step 5 therapy could result in either more expensive (i.e. IL-5, IgE biologicals) or less safe (i.e. oral corticosteroids OCS) asthma treatments compared to inhaled medication. Therefore, assessment of medication adherence is essential before initiating GINA step 5. The study aims to assess the rates and time to GINA step 5 therapy in asthma patients initiating inhaled corticosteroids and long-acting beta agonists in fixed dose combinations (ICS/LABA FDC), and assess the association between initial inhaler adherence and follow-up risk of stepping-up. Data from the 10% random sample of the Australian Pharmaceutical Benefits Scheme will be used.
• Study status:
  Finalised

Research institutions and networks

Institutions

Monash University

Study timelines

Date when funding contract was signed

Planned:30/12/2018

Actual:02/01/2019

Study start date

Planned:15/03/2019

Actual:15/03/2019

Data analysis start date

Planned:16/03/2019

Actual:16/03/2019

Date of interim report, if expected

Planned:16/04/2019

Actual:16/12/2019

Date of final study report

Planned:31/12/2019

Actual:31/12/2019

Sources of funding

Other

More details on funding

University Medical Center Groningen, Monash University

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable