Metabolic effects associated with ICS (inhaled corticosteroid) use in COPD (chronic obstructive pulmonary disease) patients with type II diabetes

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/9743
• EU PAS number:
  EUPAS6804
• Study ID:
  9743
• Official title and acronym:
  Metabolic effects associated with ICS (inhaled corticosteroid) use in COPD (chronic obstructive pulmonary disease) patients with type II diabetes
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Lay Summary: Current international guidelines for the management of chronic obstructive pulmonary disease (COPD, GOLD 2014) recommend inhaled corticosteroids (ICS) are reserved for COPD patients with severe/very severe disease and/or frequent exacerbations. However, research shows widespread use of ICS in patients with mild and moderate disease, meaning more patients are exposed to risks of side effects than would be expected under current guidelines. High doses of ICS as those typically prescribed to COPD patients have been linked to increased risks of diabetes onset and progression, yet no study has investigated this association in a cohort of COPD patients in the UK. The proposed study will investigate whether ICS treatment in COPD patients with comorbid type II diabetes has a negative impact on diabetic control, and determine whether COPD patients treated with ICS outside of guidelines are at unnecessary risk of diabetes progression. The intended audience for this study is prescribers. We plan to publish the results of this study initially at a conference, then as a manuscript in a peer-reviewed journal.
• Study status:
  Finalised

Research institution and networks

Institutions

Research in Real Life

Study timelines

Date when funding contract was signed

Actual: 04/06/2014

Study start date

Planned: 01/07/2014

Actual: 01/08/2014

Data analysis start date

Planned: 21/07/2014

Actual: 11/08/2014

Date of interim report, if expected

Planned: 31/08/2014

Actual: 07/11/2014

Date of final study report

Planned: 15/04/2015

Actual: 15/04/2015

Sources of funding

Pharmaceutical company and other private sector 

Other

More details on funding

Boehringer Ingelheim, RiRL

Study protocol

Initial protocol

ENCePP protocol submission - ICS-diabetes-COPD

Regulatory

• Was the study required by a regulatory body?:
  No