Decline In lung-function Among Patients with chronic obstructive Lung disease On maintenance therapy (DIAPLO)

Study identification

• EU PAS number:
  EUPAS19879
• Study ID:
  19880
• Official title and acronym:
  Decline In lung-function Among Patients with chronic obstructive Lung disease On maintenance therapy (DIAPLO)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Chronic 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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 13/02/2017

Actual: 13/04/2017

Study start date

Planned: 01/05/2017

Actual: 18/05/2017

Data analysis start date

Planned: 01/06/2017

Date of interim report, if expected

Planned: 01/08/2017

Date of final study report

Planned: 15/12/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pearl /AstraZeneca

Regulatory

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