Status: Finalised First registered on: 11/03/2015
Last updated on: 11/09/2015
1. Study identification
EU PAS Register NumberEUPAS8832
Official titleA real-life historic study assessing metabolic and other adverse effects of small versus large particle inhaled corticosteroids in relation to their clinical benefit in obstructive lung disease
Study title acronym
Study typeObservational study
Brief description of the studyAims to compare metabolic and other adverse effects of small (QVAR and Ciclesonide) vs. large particle (FP and Clenil) ICS in patients initiating and stepping-up their ICS therapy; and comparing results to appropriate control groups. The primary outcomes are: Diagnosis of pneumonia Diagnosis of pneumonia confirmed by chest x-ray or resulting in hospitalisation within one month of diagnosis First diagnosis of type 2 diabetes and/or prescription for anti-diabetic medication Progression of ongoing type 2 diabetes treatment to insulin Change in anti-diabetic medication Change in HbA1c value Change in BMI
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 Miss
Last name Martin
First name Jessica
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 signed01/02/2013
Start date of data collection01/11/2013
Start date of data analysis03/02/2014
Date of interim report, if expected
Date of final study report01/06/201529/04/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesTeva100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 12 Changi Business Park Avenue 1
Address line 2Level 2 
Address line 3 
CitySingapore 
Postcode486015 
CountrySingapore
Phone number (incl. country code)6568097251 
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 12 Changi Business Park Avenue 1 
Address line 2Level 2 
Address line 3 
CitySingapore 
Postcode 
CountrySingapore 
Phone number (incl. country code)6568097251 
Alternative phone number 
Fax number (incl. country code) 
Email address david@rirl.org 
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