Status: Ongoing First registered on: 14/07/2014
Last updated on: 11/03/2015
1. Study identification
EU PAS Register NumberEUPAS7072
Official titleExploratory study identifying the benefits of pMDI versus Diskus for delivering fluticasone/salmeterol combination therapy in patients with chronic obstructive pulmonary disease (COPD)
Study title acronym
Study typeObservational study
Brief description of the studyThe aims of this exploratory study are to characterise patients with chronic obstructive pulmonary disease (COPD) initiating with fluticasone/salmeterol combination therapy delivered via pressurised metered dose inhaler (pMDI; also known as Evohaler) or Diskus (also known as Accuhaler); and to identify and compare the potential benefits of using either device in the delivery of fluticasone/salmeterol combination therapy in terms of both efficacy and adverse events, in particular: a. Number of COPD exacerbations b. Development of pneumonia infections c. Type II diabetes diagnosis d. Therapeutic index e. Number of severe COPD-related events, including: i. Lower respiratory tract infections ii. Oral thrush
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 signed12/12/2013
Start date of data collection14/03/2014
Start date of data analysis13/05/2014
Date of interim report, if expected
Date of final study report01/12/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMundipharma100
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 
Postcode048581 
CountrySingapore
Phone number (incl. country code)6585456307 
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)6585456307 
Alternative phone number 
Fax number (incl. country code) 
Email address david@rirl.org 
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