Status: Ongoing First registered on: 22/11/2019
Last updated on: 02/12/2019
1. Study identification
EU PAS Register NumberEUPAS31386
Official titleThe Impact of Exacerbation Burden on Lung Function Trajectory in a Broad Asthma Population and Severe Asthma Population
Study title acronymExacerbation and lung function trajectory
Study typeObservational study
Brief description of the studySevere asthma exacerbations may play a significant role in lung function decline through their potential contribution to airway remodelling through inducing spikes of pulmonary inflammation. This study aims to investigate if there is an association between exacerbation burden and lung function decline in a broad asthma patient population using longitudinal (minimum 5 years of follow-up), real-life data collected on a large scale. The value of this study is its focus on the key enduring evidence gaps in in the current literature - inpatient representativeness, follow-up time and analysis methodology that is not covered by available studies of exacerbation burden and lung function decline in asthma patients. Treatment targets that improve asthma control/reduce exacerbations would be of additional benefit if it can be demonstrated rigorously that this improvement is associated with better long-term lung function status, and therefore decreased risk of permanent airway obstruction and/or other asthma morbidities.
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
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

Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Bulgaria
Canada
Greece
Ireland
Italy
Japan
Korea, Republic of
Kuwait
Spain
United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/04/201830/04/2018
Start date of data collection31/08/201815/10/2018
Start date of data analysis01/07/201931/07/2019
Date of interim report, if expected
Date of final study report31/12/2019
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
OtherOPCG50
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 15 Coles Lane
Address line 2 
Address line 3 
CityOakington, Cambridge 
PostcodeCB24 3BA 
CountryUnited Kingdom
Phone number (incl. country code)44-7787-905057 
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 15 Coles Lane 
Address line 2 
Address line 3 
CityOakington, Cambridge 
PostcodeCB24 3BA 
CountryUnited Kingdom 
Phone number (incl. country code)44-7787-905057 
Alternative phone number 
Fax number (incl. country code) 
Email address dprice@opri.sg 
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