Study identification

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 institutions and networks

Institutions

Contact details

Rafael Mares

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
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Data analysis start date

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Date of interim report, if expected

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Actual:

Date of final study report

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Sources of funding
Pharmaceutical company and other private sector 
Other

More details on funding

Boehringer Ingelheim, RiRL
Regulatory

Was the study required by a regulatory body?

No