Status: Finalised First registered on: 19/04/2016
Last updated on: 16/01/2019
1. Study identification
EU PAS Register NumberEUPAS13218
Official titleHistorical matched-cohort study assessing whether the use of inhaled corticosteroids shortens time to first diagnosis or accelerates the progression of side effects compared to non-ICS therapies in patients with Chronic Obstructive Pulmonary Disease.
Study title acronymICS use in COPD patients and risk of side effects
Study typeObservational study
Brief description of the studyThe objective is to analyze the relationship between ICS use and Type 2 Diabetes onset, Type 2 Diabetes worsening disease control and disease progression, osteoporosis onset, pneumonia incidence and overuse of ICS. Firstly, these endpoints will be compared between an ICS therapy cohort and non-ICS therapy cohort. Subsequently, they will be analyzed within the ICS-therapy cohort only and compared by ICS average daily dose, ICS cumulative dose, and ICS drug and inhaler device type. This is a historical, matched-cohort study. The study time period is 1990 - present. To account for changes in ICS prescribing in the study period, patients will be matched on index date to ensure they follow a similar time path. For both treatment cohorts a 1-year baseline period prior to the date of first prescription of ICS therapy or first/additional prescription of non-ICS therapy (i.e. the index date) will be followed by a minimum 1-year outcome period. All of the patient’s available data post index date will be utilized. To be included in the ICS cohort, patients may switch between different types of ICS in the outcome period as long as ICS remain part of therapy. Exposure of ICS will be measured from the index date to realization of the outcome (e.g. a Type 2 Diabetes diagnosis) or from index date to the end of the follow up period if the outcome does not occur. A variable will be created, exposure time, to be used as an adjustment in all multivariable analyses. To be included in the non-ICS cohort, patients may be prescribed SABA, LABA, SAMA, LAMA, Methylxanthines and/or compound bronchodilator preparations and may switch between therapies in the outcome period as long as ICS are not prescribed. The number of OCS prescriptions per year of the outcome period and overall prescriptions in the outcome period will be accounted for in the analysis.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
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 belongsOPRI Pte Ltd
Department/Research groupResearch in Real Life Ltd
Organisation/affiliationOPRI Pte Ltd
Website/Homepagehttps://opri.sg/
Details of (Primary) lead investigator
Title Professor
Last name Price
First name David
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 signed01/12/2015
Start date of data collection01/05/201614/07/2016
Start date of data analysis26/06/2016
Date of interim report, if expected
Date of final study report12/04/201710/07/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesNovartis100
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 15a Coles Lane
Address line 2Oakington 
Address line 3 
CityCambridge 
PostcodeCB24 3BA 
CountryUnited Kingdom
Phone number (incl. country code)44-1223-967835 
Alternative phone number 
Fax number (incl. country code) 
Email address dprice@opri.sg
Public Enquiries
Title Professor 
Last name Price 
First name David 
Address line 15a Coles Lane 
Address line 2Oakington 
Address line 3 
CityCambridge 
PostcodeCB24 3BA 
CountryUnited Kingdom 
Phone number (incl. country code)44-1223-967835 
Alternative phone number 
Fax number (incl. country code) 
Email address dprice@opri.sg 
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