Status: Finalised First registered on: 03/10/2018
Last updated on: 05/02/2019
1. Study identification
EU PAS Register NumberEUPAS25489
Official titleDemographic and Clinical Characteristics of Severe Asthma Patients Worldwide
Study title acronym
Study typeObservational study
Brief description of the studyThis study aims to inform the asthma scientific community of the demographic and clinical characteristics of severe asthma patients seen at severe asthma centres across the globe. This will help drive the next key research questions to be asked at the country, region, and international level. This is a cross-sectional study to describe the severe asthma population, utilising data from the International Severe Asthma Registry (ISAR) to descriptively illustrate differences and similarities of demographic and clinical attributes of severe asthma patients globally. The study will include adult severe asthma patients receiving treatment according to the Global Initiative of Asthma (GINA) Step 5 or uncontrolled on GINA Step 4. Descriptive statistics will be summarized for demographic factors and clinical characteristics, including medical history, healthcare resource utilisation, blood test measurements, fractional exhaled nitric oxide (FeNO) test, comorbidities and medication use categories.
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 nameOptimum Patient Care Global Limited
Centre locationUK
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?
Yes

Optimum Patient Care (OPC)
Respiratory Effectiveness Group (REG)
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Australia
Italy
Korea, Republic of
United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/05/201715/05/2017
Start date of data collection01/11/201716/04/2018
Start date of data analysis
Date of interim report, if expected15/10/2018
Date of final study report31/12/201831/01/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca50
Charities
Government body
Research councils
EU funding scheme
OtherOPC Global50
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 15 Coles Lane
Address line 2Oakington 
Address line 3 
CityCambridge 
PostcodeCB24 3BA 
CountryUnited Kingdom
Phone number (incl. country code)44-7787-905057 
Alternative phone number44-1223-967582 
Fax number (incl. country code) 
Email address dprice@opri.sg
Public Enquiries
Title Professor 
Last name Price 
First name David 
Address line 15 Coles Lane 
Address line 2Oakington 
Address line 3 
CityCambridge 
PostcodeCB24 3BA 
CountryUnited Kingdom 
Phone number (incl. country code)44-7787-905057 
Alternative phone number44-1223-967582 
Fax number (incl. country code) 
Email address dprice@opri.sg 
Top