View Study

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

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

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

11. Scope of the study

What is the scope of the study?

Disease epidemiology

Primary scope : Disease epidemiology

12. Main objective(s)

What is the main objective of the study?

This study aims to investigate whether the burden of severe asthma exacerbations is associated with lung function decline in asthma patients The main objective of this study is to assess the role of exacerbation burden as a predictor of lung function declined in asthma patients with at least 5 years of lung function recording (follow-up) and 3 or more lung function readings (spirometry or PEF)

Are there primary outcomes?Yes

Lung function decline measured by Forced expiratory value in 1 second (L) and/or Peak expiratory flow rate (L/minute).

Are there secondary outcomes?No

13. Study design

What is the design of the study?

Cohort study

14. Follow-up of patients

Will patients be followed up?Not applicable/no follow-up

15. Data analysis plan

Please provide a brief summary of the analysis method

The study will assess a historical cohort of patients diagnosed with asthma, who have 3 or more of either PEFR or FEV1 readings taken over a minimum of 5 years from their 18th birthday. The index date, i.e. the start of follow-up, will be the first date on which a lung function reading is recorded after age 18. Baseline is defined as the year prior to and including the index date. The association between exacerbation burden and lung function will be explored under a mixed-effects regression modelling approach. The variation in lung function trajectories between individual study subjects is accounted for by including a random intercept and slope of lung function over time at the patient level in the model. The relationship between exacerbation burden and the slopes of lung function is modelled by the interaction term of exacerbation burden and follow up time in years in the mixed effects model. Non-linear trajectories will be considered by the inclusion of time polynomials in the model