Status: Finalised First registered on: 19/06/2014
Last updated on: 15/05/2015
1. Study identification
EU PAS Register NumberEUPAS6804
Official titleMetabolic effects associated with ICS (inhaled corticosteroid) use in COPD (chronic obstructive pulmonary disease) patients with type II diabetes
Study title acronym
Study typeOther: Retrospective observational study
Brief description of the studyLay 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsRIRL
Department/Research group
Organisation/affiliationResearch in Real Life Ltd.
Website/Homepagewww.rirl.org
Details of (Primary) lead investigator
Title Dr
Last name Mares
First name Rafael
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed04/06/2014
Start date of data collection01/07/201401/08/2014
Start date of data analysis21/07/201411/08/2014
Date of interim report, if expected31/08/201407/11/2014
Date of final study report15/04/201515/04/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBoehringer Ingelheim50
Charities
Government body
Research councils
EU funding scheme
OtherRiRL50
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 1University of Aberdeen
Address line 2 
Address line 3 
CityAberdeen 
PostcodeAB24 3FX 
CountryUnited Kingdom
Phone number (incl. country code)441223967855 
Alternative phone number 
Fax number (incl. country code) 
Email address david@rirl.org
Public Enquiries
Title Professor 
Last name Price 
First name David 
Address line 1University of Aberdeen 
Address line 2 
Address line 3 
CityAberdeen 
PostcodeAB24 3FX 
CountryUnited Kingdom 
Phone number (incl. country code)441223967855 
Alternative phone number 
Fax number (incl. country code) 
Email address david@rirl.org 
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