Status: Ongoing First registered on: 14/07/2017
Last updated on: 14/07/2017
1. Study identification
EU PAS Register NumberEUPAS19879
Official titleDecline In lung-function Among Patients with chronic obstructive Lung disease On maintenance therapy (DIAPLO)
Study title acronymDIAPLO
Study typeObservational study
Brief description of the studyChronic obstructive pulmonary disease (COPD) is a respiratory condition affecting airflow in the lungs, leading to symptoms such as shortness of breath and tightness in the chest. It is not reversible and becomes gradually worse over time. No single drug has been shown to prevent progressive loss of lung function. However, if treated early with a triple combination of inhaled drugs, relevant effects may be achieved. The proposed study aims to explore lung function decline over time, in patients at the early stages of COPD who are receiving various types of treatment. Using several years of anonymous patient information from General Practices, the study will initially assess an existing tool that predicts whether patients with COPD will have a rapid decline in lung function. Such tools can be highly useful in planning treatment strategies and it is important to investigate whether they are accurate. The study will then identify those patients who are likely to have a rapid decline, separate them by the treatment they were receiving, and compare their lung function decline over time. Differences between individual’s observed and predicted FEV1 values (calculated from the validated prediction model or a newly developed model) will be described after initiation of maintenance therapies. A matched comparison of FEV1 decline of patients initiated on triple therapy and patients on minimal inhalation therapy will be performed using a multilevel model for change. Conditional negative binomial regression and stratified Cox-regression will be used to analyse differences in exacerbation rates and time to first COPD-related hospitalisation respectively. The study will obtain much needed evidence of whether decline can be reduced by particular treatment regimens and could lead to improved management of this condition.
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 to which the investigator belongsOPRI Pte Ltd
Department/Research groupObservational and Pragmatic Research Institute Pte Ltd
Organisation/affiliationOPRI Pte Ltd
Website/Homepagewww.opri.sg
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?
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 signed13/02/201713/04/2017
Start date of data collection01/05/201718/05/2017
Start date of data analysis01/06/2017
Date of interim report, if expected01/08/2017
Date of final study report15/12/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesPearl /AstraZeneca100
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 15a Coles Lane
Address line 2Oakington 
Address line 3 
CityCambridge 
PostcodeCB24 3BA 
CountryUnited Kingdom
Phone number (incl. country code)0031597856891 
Alternative phone number 
Fax number (incl. country code) 
Email address marjan@opri.sg
Public Enquiries
Title Professor 
Last name Price 
First name David 
Address line 15a Coles Lane 
Address line 2Oakington 
Address line 3 
CityCambridge 
PostcodeCB24 3BA 
CountryUnited Kingdom 
Phone number (incl. country code)003159856891 
Alternative phone number 
Fax number (incl. country code) 
Email address marjan@opri.sg 
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