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Predictors of chronic obstructive pulmonary disease progression
Proposal
1692
Title of Proposed Research
Predictors of chronic obstructive pulmonary disease progression
Lead Researcher
Akihiro Hisaka
Affiliation
Laboratory of Clinical Pharmacology and Pharmacometrics, Graduate School of Pharmaceutical Sciences, Chiba university, Chiba, Japan
Funding Source
None
Potential Conflicts of Interest
None
Data Sharing Agreement Date
13 September 2017
Lay Summary
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung syndrome that affects millions of people, and it is estimated to become the third leading cause of death worldwide in 2030. Although it is well known that COPD is characterized by a progressive and life-long airflow limitation, the rate of decline in lung function is extremely variable across patients.
The lung function of patients with COPD is confirmed using a pulmonary function test called “spirometry”. A key value of spirometry is the forced expiratory volume in 1 s (FEV1), which is used to stage COPD severity according to the Global Initiative for Chronic Obstructive Lung Disease guidelines. People with COPD demonstrate a decline in FEV1 over time, and the FEV1 can be crucial in choosing the best treatment option and predicting prognosis.
Previously, a number of clinical studies have been conducted to analyze FEV1 change and its influencing factors in patients with COPD. However, few studies have focused on lifelong FEV1 change because it is practically difficult to perform a cohort study over several decades. Moreover, although some investigations of an FEV1 prediction model have been performed, no model with the ability to predict lifelong changes in FEV1 in patients with COPD has been developed. Therefore, the aim of this study is to develop a lifelong FEV1 model and identify its influencing factors. Because it is practically difficult to perform a cohort study over several decades, we are planning to assume decades-long FEV1 longitudinal change by using a model-based meta-analysis with Statistical Restoration of Fragmented Time-course (SReFT). SReFT is a new method we previously developed to restore long-term time courses from numerous short fragments by using an extended nonlinear mixed-effects estimation method.
This study would allow the prediction of lifelong FEV1 change in COPD patients based on their background. It would provide useful information in predicting prognosis and choosing the best treatment option for each patient with COPD. In addition, this study is expected to propose a novel and efficient approach for understanding disease progression in chronic diseases. SReFT can be applied not only to COPD but to almost all chronic diseases. With SReFT, we will be able to assume long-term disease progression without conducting long-term clinical studies.
Study Data Provided
[{ "PostingID": 1413, "Title": "BI-205.372", "Description": "Tiotropium / Respimat One Year Study in COPD.
Medicine: tiotropium bromide, Condition: Pulmonary Disease, Chronic Obstructive, Phase: 3, Clinical Study ID: 205.372, Sponsor: Boehringer Ingelheim" },{ "PostingID": 3876, "Title": "BI-1237.5", "Description": "Tiotropium+Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)
Medicine: tiotropium bromide + olodaterol, Condition: Pulmonary Disease, Chronic Obstructive, Phase: 3, Clinical Study ID: 1237.5, Sponsor: Boehringer Ingelheim" },{ "PostingID": 3877, "Title": "BI-1237.6", "Description": "Tiotropium +Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)
Medicine: tiotropium bromide + olodaterol, Condition: Pulmonary Disease, Chronic Obstructive, Phase: 3, Clinical Study ID: 1237.6, Sponsor: Boehringer Ingelheim" },{ "PostingID": 4109, "Title": "GSK-HZC113782", "Description": "A Clinical Outcomes Study to compare the effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg with placebo on Survival in Subjects with moderate Chronic Obstructive Pulmonary Disease (COPD) and a history of or at increased risk for cardiovascular disease
Medicine: fluticasone furoate/vilanterol, Condition: Pulmonary Disease, Chronic Obstructive, Phase: 3, Clinical Study ID: HZC113782, Sponsor: GSK" }]
Statistical Analysis Plan
The statistical analysis plan will be added after the research is published.
Publication Citation
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