Status: Finalised First registered on: 25/03/2014
Last updated on: 10/10/2018
1. Study identification
EU PAS Register NumberEUPAS6147
Official titleReal-world effectiveness of extra-fine Ciclesonide (Alvesco®) versus standard particle inhaled corticosteroid (ICS)
Study title acronym
Study typeObservational study
Brief description of the studyAim of the study: A retrospective, database analysis comparing effectiveness (in terms of exacerbations prevention and asthma control) of Ciclesonide, an extra-fine (EF) particle ICS, with other commonly prescribed standard particle (SP) ICS therapies in patients prescribed asthma therapy from the Netherlands. Data source: the PHARMO Database Network, comprising pharmacy and hospital discharge records for approximately 20% of the Dutch population. Study population: The study population will include patients aged 12-60 years with a history of ≥2 prescriptions for asthma therapy and initiating ICS treatment as EF-ICS ciclesonide or SP-ICS. Data will be collected over one year before (baseline) and one year after (outcome) treatment initiation. Study period is September 2005 – December 2012. Potential COPD patients (>60 years old and those using long-acting muscarinic antagonists) will be excluded. Primary outcomes: Severe exacerbation rate in the year after initiation of ICS therapy, defined as asthma-related hospital admissions OR use of acute oral steroids (based on the American Thoracic Society/European Respiratory Society task force definition). Modified definition of Risk Domain Asthma Control in the year after initiation of ICS therapy, defined as absence of asthma-related hospital admissions AND absence of prescriptions for acute courses of oral steroids. Modified definition of Overall Asthma Control in the year after initiation of ICS therapy defined as no asthma-related hospital admissions AND no prescriptions for acute courses of oral steroids AND average daily dose of ≤200mcg salbutamol / ≤500mcg terbutaline.
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 groupObservational and Pragmatic Research Institute Pte Ltd
Organisation/affiliationOPRI Pte Ltd
Website/Homepagewww.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
Multiple centres

In total how many centres are involved in this Study?2
Countries in which this study is being conducted
National study

Netherlands
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed31/03/201418/06/2014
Start date of data collection01/04/201401/04/2014
Start date of data analysis22/05/201422/05/2014
Date of interim report, if expected
Date of final study report22/12/201422/12/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesTakeda Pharmaceuticals100
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 116 Raffles Quay
Address line 2#33-03 
Address line 3Hong Leong Building 
CitySingapore 
Postcode 
CountrySingapore
Phone number (incl. country code)44-1223967829 
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 116 Raffles Quay 
Address line 2#33-03 
Address line 3Hong Leong Building 
CitySingapore 
Postcode 
CountrySingapore 
Phone number (incl. country code)44-1223967829 
Alternative phone number 
Fax number (incl. country code) 
Email address david@rirl.org 
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