Goal 3: Advance Translational Research

Early detection and treatment of COPD

Early detection and treatment of COPD

a. Best tests to detect

b. Impact of early treatment

c. Impact of early treatment on disease progression

Submitted by (@nhlbiforumadministrator)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Name of idea submitter and other team members who worked on this idea : American Thoracic Society member

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2 up votes
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Goal 1: Promote Human Health

Funding of Stem Cell/Lung Regeneration Research

How to "cure" a chronic, incurable disease - A potential giant step in saving the lives of many thousands of Americans, and potentially millions worldwide, who are afflicted with COPD, the third leading cause of death in the U.S. The financial effect of COPD in the United States alone is well over $50 billion per year. It is estimated that some 30 million Americans have COPD, which of course means that at least that ...more »

Submitted by (@jimandmarynelson)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

COPD is chronic and presently incurable. Although it sickens and disables nearly 30 million Americans, and kills 140,000 of them each year, the only "cure" is a lung transplant. Due to the scarcity of organ donors and the requirements that lungs be removed from the donor in a hospital setting, only about 1,400 lung transplants are performed in the Unites States each year. Unfortunately, transplants are fraught with complications, side effects, and potential rejections, and on the average, add only about 5 years to the life of the recipient. The best potential solution lies with the stem cell and lung regeneration research that is presently occurring at a few centers around the country. Ideally, the re-engineered lungs would be composed of the patient's own stem cells, eliminating a great many of the current transplant issues.

Feasibility and challenges of addressing this CQ or CC :

Research is presently in process on construction or reconstruction of human organs. There has been success in creating some of the simpler organs, such as the esophagus and bladder, and a Medical Center in Galveston has implanted re-engineered lung is a pig. As of my latest conversation with the lead Doctor on the project, results so far are promising.

There is general agreement among the researchers with whom I have communicated that we are between 5 and 20 years away from human trials of re-generated lungs using the patient's own stem cells, but more funding means more research which means more possibilities of the saving of lives.

Name of idea submitter and other team members who worked on this idea : Jim Nelson - COPD Foundation MASAC/CAC/BOARD Committee Member

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25 net votes
32 up votes
7 down votes
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Goal 3: Advance Translational Research

Identifying Biomarkers of Chronic Lung Diseases

What are the biomarkers that identify expression and progression of specific subtypes of chronic lung disease?

Submitted by (@jdc000)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Compelling Question (CQ)

Details on the impact of addressing this CQ or CC :

Most chronic lung diseases, including COPD, do not have biomarkers that reflect disease pathogenesis accurately. Readily measurable biomarkers, especially in peripheral blood, would be key tools for clinical trials and studies of disease heterogeneity.

Feasibility and challenges of addressing this CQ or CC :

The most useful chronic lung disease biomarkers would be proteins, metabolites, or gene expression measurements in peripheral blood. Defining useful peripheral blood biomarkers that reflect lung disease pathogenesis will require validation that the lung disease process can be captured in peripheral blood measurements.

Name of idea submitter and other team members who worked on this idea : Ed Silverman, James Crapo and COPDGene Executive Committee

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42 net votes
62 up votes
20 down votes
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Goal 2: Reduce Human Disease

Diagnosis and Treatment of the Asthma-COPD Overlap Syndrome

Asthma-COPD overlap syndrome is common and associated with increased morbidity and greater healthcare costs. However, ACOS patients are usually excluded from studies of either disease. There is a compelling need for research in order to define objective diagnostic criteria for ACOS.

Submitted by (@craighersh)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Compelling Question (CQ)

Details on the impact of addressing this CQ or CC :

Better diagnostic criteria as well as biomarkers will allow for efficient targeting of specific therapies for ACOS, such as biologic therapies developed for asthma.

Feasibility and challenges of addressing this CQ or CC :

Since ACOS subjects are usually excluded from COPD or asthma trials, this will require identification of study populations that did not exclude ACOS and/or enrollment of ACOS subjects into a new study.

Name of idea submitter and other team members who worked on this idea : C. Hersh

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30 net votes
31 up votes
1 down votes
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Goal 3: Advance Translational Research

Establish COPD Biomarkers

Specific biomarkers to monitor COPD disease activity are needed.

Submitted by (@jsullivan)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

Much is understood about the pathogenesis of COPD at the cellular and biochemical level. There is no established way these insights can be used to test or implement new medicines. An explicit and economical set of procedures need to be established that will facilitate the development of new medicines and guide their clinical use.

Feasibility and challenges of addressing this CQ or CC :

Many very small studies have identified biomarkers that relate to COPD activity in large groups of patients. There is no clear regulatory path for these insights to lead to tests that can be used with confidence in the development and implementation of novel treatments. Realistic regulatory pathways and criteria should be adopted to facilitate the development biomarkers of disease activity in COPD.

Name of idea submitter and other team members who worked on this idea : COPD Foundation, COPD Biomarkers Qualification Consortium

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15 net votes
17 up votes
2 down votes
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Goal 3: Advance Translational Research

Animal Models for COPD -- Core Facilities

COPD is a major health problem with more than 140,000 deaths per year and yet there is a relative paucity of treatments that might modify the course of this disease. In part, this is due to the poor efficiency of animal models that require months of exposure to cigarette smoke. Moreover, there are no well validated small animal models of chronic mucus hypersecretion. Funding of core facilities that could both provide ...more »

Submitted by (@rwise0)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

Funding of core facilities that could both provide support for researchers wishing to study COPD, and the development of efficient research models as well as models of chronic bronchitis would be a major advance for screening for treatments of COPD.

Feasibility and challenges of addressing this CQ or CC :

Current technology is well established for exposure of small animals to combustible tobacco smoker. However there remains to be developed standardized exposures to e-Cigarettes and Biomass fuels.

Name of idea submitter and other team members who worked on this idea : Robert A. Wise

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20 net votes
24 up votes
4 down votes
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Goal 2: Reduce Human Disease

Understanding Pathobiology of Exacerbations

COPD exacerbations contribute to poor quality of life, lung function and functional decline. In addition, they are costly to the patient and to health care cost. However, they remain defined exclusively on symptoms and constitute a “soft” endpoint. Actually, the number of exacerbations has become the GOLD standard to establish the risk of outcome (exacerbations). However, a mild episode that only requires outpatient ...more »

Submitted by (@nhlbiforumadministrator)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

Outcome measured: Level of health care resource utilization: ambulatory therapy, hospitalization to ward and non-invasive ventilation and admission to ICU for ventilatory failure.

Analysis: To evaluate the level of accuracy of the re-classification of the episode and to relate the level of biomarker change to the severity of the episode.

Feasibility and challenges of addressing this CQ or CC :

Study Plan

A change in paradigm can be explored using an approach similar to that developed in the field of cardiovascular disease for coronary artery disease. This can be seen in the table from the article (Celli B and Barnes P J. Exacerbations of COPD. 2007;29:1224), which shows the basis for the proposal where we would add the biomarkers described above.

Name of idea submitter and other team members who worked on this idea : American Thoracic Society member

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1 net vote
1 up votes
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Goal 3: Advance Translational Research

The use of administrative and billing data in COPD care quality improvement

What is the validity of administrative/billing data to evaluate the quality of COPD care as part of quality improvement initiatives? What care practices can be assessed using these data?

Submitted by (@ngrude)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Compelling Question (CQ)

Name of idea submitter and other team members who worked on this idea : Nina Bracken, COPD Foundation advocate

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2 up votes
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Goal 2: Reduce Human Disease

Low-dose and non-ionizing imaging for chronic lung disease

Critical Challenge

Submitted by (@str0001)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

Imaging plays a crucial role in the initial evaluation of patients with suspected or surveillance of those with confirmed diffuse chronic lung disease. Attention towards developing alternative non-ionizing imaging technologies and evaluating the efficacy of radiation dose saving techniques will impact a large patient population.

Feasibility and challenges of addressing this CQ or CC :

Imaging, particularly computed tomography (CT) plays a major role in the evaluation of diffuse pulmonary disease. High resolution CT (HRCT) characterizes parenchymal patterns of lung disease, identifies areas amenable to biopsy, and aids in decisions pertaining to workup and therapy of lung disease. With multidetector CT technology, volumetric HRCT enables evaluation of the entire lung volume for diffuse lung disease. The utility of CT needs to be balanced with the exposure of patients to ionizing radiation, particularly younger-aged individuals who are more sensitive to ionizing radiation. In CT, dose-saving techniques enable imaging of the parenchyma at ultra-low dose levels. Additionally, an understanding of low radiation-dose CT techniques that preserve the diagnostic ability for diffuse lung disease, while maintaining the precision of quantitative measures, is needed. Magnetic resonance imaging (MR) is underutilized as an imaging tool given respiratory motion and limitations in spatial resolution. A need exists to develop and apply MR imaging techniques with spatial resolution approaching that of high resolution CT. Promising advances in the MR technology has occurred, and continued development and application will provide alternative and non-ionizing options for imaging patients with diffuse lung disease affecting both the parenchyma and airways.

Name of idea submitter and other team members who worked on this idea : Society of Thoracic Radiology

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8 net votes
10 up votes
2 down votes
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Goal 1: Promote Human Health

THE RELEVANCE OF PREVENTION TRIALS

Prevention trials, implemented to reduce or delay progression to overt disease in a population at risk to the disease, are an important approach to health promotion. Therapies shown to reduce disease severity in patients with a specific disease are obvious, but not the only, candidates for a prevention trial in populations at high risk for prevalent diseases (such as heart failure, diabetes, COPD, asthma in children). ...more »

Submitted by (@media0)

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Critical Challenge (CC)

Details on the impact of addressing this CQ or CC :

The impact of implementing such trials is considerable. They will clearly address an important component of NHLBI’s mission with respect to effectiveness of therapies and behavioral interventions, and it has minimal and clearly definable overlap with commercial trials of specific therapeutic products. It will also provide an important public health focus – preventing disease or reducing the impact of disease processes, thus potentially reducing chronic care costs and increasing years of useful life.

Feasibility and challenges of addressing this CQ or CC :

The biggest challenge in designing and implementing prevention trials is identifying the target, “at risk” population most likely to develop the clinical disease from known biomarkers or early signs/symptoms. Increasing availability of large, population-based registries or databases maintained for other purposes provides a very cost-efficient mechanism to electronically screen and identify “at risk” individuals. The same mechanism may also facilitate implementation of pragmatic, electronically managed, cost efficient trials.

Name of idea submitter and other team members who worked on this idea : Sonja McKinlay other Team Members: Susan Assmann and Paul Stark

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7 net votes
10 up votes
3 down votes
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