Status: Finalised First registered on: 24/11/2014
Last updated on: 24/11/2014
1. Study identification
EU PAS Register NumberEUPAS8019
Official titleCharacterising patients at risk of failed Diskus use in primary care
Study title acronym
Study typeObservational study
Brief description of the studyThe aim of this study is to identify patient characteristics in a large sample of primary care patients that use a Diskus inhaler. The prevalence and factors associated with inhaler misuse will be investigated. In addition we aim to assess the relationship between inhalation technique and clinical outcomes. These results should assist physicians in evaluating the potential impact of the type of device prescribed to a patient. This study will answer the following questions: • Which serious errors in Diskus inhaler technique are most frequently made? • Are certain patient characteristics linked to incorrect inhaler technique for Diskus? • Are patient reported outcomes linked to incorrect inhaler technique for Diskus? • Does incorrect inhaler technique correlate to asthma risk assessment? In addition, the type and frequency of serious errors being performed when using Diskus will be analysed to better characterise patient errors and identify ways in which inhaler technique may be improved.
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 Davis
First name Emily
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
International study

Australia
France
Italy
Netherlands
Norway
Spain
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed03/09/201303/09/2013
Start date of data collection01/06/201101/06/2011
Start date of data analysis10/10/201314/10/2013
Date of interim report, if expected10/01/201410/01/2014
Date of final study report19/03/201424/11/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesTeva50
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 116 Raffles Quay
Address line 2#33-03 
Address line 3Hong Leong Building 
CitySingapore 
Postcode048581 
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 
Postcode048581 
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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