The Impact of Exacerbation Burden on Lung Function Trajectory in a Broad Asthma Population and Severe Asthma Population (Exacerbation and lung function trajectory)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/32519
• EU PAS number:
  EUPAS31386
• Study ID:
  32519
• Official title and acronym:
  The Impact of Exacerbation Burden on Lung Function Trajectory in a Broad Asthma Population and Severe Asthma Population (Exacerbation and lung function trajectory)
• DARWIN EU® study:
  No
• Study countries:
  Bulgaria

  Canada

  Greece

  Ireland

  Italy

  Japan

  Korea, Republic of

  Kuwait

  Spain

  United Kingdom

  United States
• Study description:
  Severe 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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Optimum Patient Care (OPC)

United Kingdom

Networks

Respiratory Effectiveness Group (REG)

Belgium

Denmark

France

Germany

Greece

Hungary

Italy

Netherlands

Spain

Sweden

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 01/04/2018

Actual: 30/04/2018

Study start date

Planned: 31/08/2018

Actual: 15/10/2018

Data analysis start date

Planned: 01/07/2019

Actual: 31/07/2019

Date of final study report

Planned: 31/12/2019

Sources of funding

Other

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca, OPCG

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable