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10.01.24

Advancing COPD Clinical Trials: The Role of the COPD Population Screener (COPD-PS)

Middle-aged woman using nebulizer to manage COPD symptoms while seated on couch.

Advancing COPD Clinical Trials: The Role of the COPD Population Screener (COPD-PS)

Chronic Obstructive Pulmonary Disease (COPD) is a progressive lung disease that causes breathing difficulties and severely impacts the quality of life for millions of people worldwide. As one of the leading causes of death and disability globally,1 COPD has become a focal point for clinical research efforts aimed at developing new treatments, improving patient care and enhancing health outcomes.

But a major challenge in facilitating COPD clinical trials is the early identification of suitable participants for clinical trials. Many patients are diagnosed only after the disease has progressed, limiting opportunities for effective intervention.

To address this challenge, COPD screening tools like the COPD Population Screener (COPD-PS) from QualityMetric have emerged as essential aids in the early detection of COPD. The COPD-PS is a simple yet effective patient-reported outcome (PRO) survey that can identify individuals at risk for COPD, making it an invaluable resource in clinical trials for COPD.

Learn how the COPD-PS helps researchers optimize their studies, improve patient outcomes and reduce trial costs by supporting earlier diagnosis and improving participant selection.

A Global Health Challenge

Chronic obstructive pulmonary disease is an umbrella term for progressive lung diseases like emphysema and chronic bronchitis.1 These conditions cause irreversible airflow obstruction, leading to symptoms such as shortness of breath, chronic cough and chest tightness.1 The World Health Organization (WHO) estimates that COPD is one of the top ten leading causes of death worldwide.2

COPD is a progressive condition, which means that symptoms tend to appear gradually but worsen as time goes on. This can potentially limit a person’s capacity to carry out everyday tasks, and in severe cases, COPD can make it difficult to perform even simple activities like walking, preparing meals or managing personal care.1

COPD Early Detection

One of the key challenges in managing COPD is that it often remains undiagnosed until the disease has advanced. This late diagnosis complicates treatment and can negatively impact patients’ quality of life and reduce the efficacy of therapeutic interventions. COPD early detection is critical to managing the disease and improving long-term outcomes for patients. This is especially important in clinical trials for COPD, where identifying suitable participants can make or break a study’s success.

Early detection is fraught with challenges, however. Researchers often face difficulty finding patients who meet the criteria for trial enrollment, particularly in populations where COPD screening is not widespread. This is where the COPD Population Screener can have a significant impact. COPD screening tools help overcome the hurdles of early diagnosis by identifying at-risk individuals before their symptoms become severe, making them ideal candidates for clinical trials.

Recent research has highlighted the importance of identifying patients early through mass screening using questionnaires, concluding that the COPD-PS in particular may be useful for identifying the early stages of COPD in a medical health check-up population.3 By enabling early diagnosis, tools like the COPD-PS are critical to the success of clinical trials aimed at developing new treatments for COPD.

The COPD Population Screener

The COPD-PS is a five-item, self-administered questionnaire designed to identify individuals who may be at risk for COPD. The screener is straightforward, cost-effective and easy to use, making it an ideal tool for both clinical practice and research settings. The COPD-PS is a valuable asset for COPD clinical trials, where efficient participant selection is crucial for beneficial research outcomes.

The five questions in the COPD-PS are used to assess key symptoms and risk factors associated with COPD, such as chronic cough, wheezing, shortness of breath and exposure to risk factors like smoking. Patients who score above a certain threshold on the screener are considered at risk for COPD and may be referred for further diagnostic testing, such as spirometry, to confirm the diagnosis.

By leveraging a simple, self-administered and self-scored tool, healthcare professionals may support increased awareness, earlier symptom recognition and the use of spirometry for accurate diagnosis.

Older man in a yellow sweater using a tablet to complete the COPD population screener while sitting on a couch.

COPD-PS Validation Studies

Numerous studies have validated the effectiveness of the COPD-PS in both clinical and research settings. For example, the validation of the Spanish version of COPD-PS has demonstrated its reliability and accuracy in identifying at-risk individuals in non-English-speaking populations.4 Ten primary care centers—with participants that included 94 controls and 79 cases with chronic airflow obstruction—demonstrated that the Spanish COPD-PS resulted in good psychometric properties.4

Another key study assessed the economic efficiency of early COPD screening in a rural Chinese population.5 Using a combination of the COPD Population Screener and pulmonary function tests, the study found that early screening led to an increase of 0.28 quality-adjusted life years (QALYs) and was cost-effective, requiring significantly lower costs than the willingness-to-pay threshold.5

Studies like these underscore the importance of incorporating COPD screening tools like the COPD-PS into COPD clinical trials. The Chinese study also demonstrates the effectiveness of the COPD-PS in a low-resource setting, highlighting its potential for use in underserved populations around the world.5

The Future of COPD Screening

Advancing COPD research requires the ability to screen and identify at-risk individuals early, allowing them to participate in clinical trials for COPD that generate valuable insights into the disease. Early detection can lead to more effective interventions and better patient outcomes.

As the demand for more effective COPD treatments continues to grow, tools like the COPD Population Screener will play an increasingly important role in illuminating new research and improving patient outcomes.

By offering a reliable, validated and cost-effective solution for screening participants—with proven validity across diverse populations—the COPD-PS is helping to shape the future of COPD clinical trials. It not only streamlines the recruitment process and boosts the accuracy of participant selection but may also enhance trial efficiency and lower overall costs. For researchers, this means faster, more reliable results and a greater potential for developing new treatments that can improve the lives of COPD patients worldwide.

For more information on how the COPD Population Screener can benefit your clinical research, contact QualityMetric. Our team can help you license the COPD-PS and integrate this screening tool into your upcoming clinical trials.

References

1. National Heart, Lung, and Blood Institute. COPD: Causes, risk factors, and prevention: What Is COPD? National Institutes of Health. 2023. https://www.nhlbi.nih.gov/health/copd

2. World Health Organization. The top 10 causes of death. 2024. https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death

3. Hanibuchi M, Saijo A, Mitsuhashi A, Kajimoto T, Kitagawa T, Nishioka Y. The efficacy of mass screening for chronic obstructive pulmonary disease using screening questionnaires in a medical health check-up population. Respir Investig. 2022;60(6):815-821. https://doi.org/10.1016/j.resinv.2022.07.005

4. Miravitlles M, Llor C, Calvo E, Diaz S, Díaz-Cuervo H, Gonzalez-Rojas N. Validación de la versión traducida del Chronic Obstructive Pulmonary Disease-Population Screener (COPD-PS). Su utilidad y la del FEV₁/FEV₆ para el diagnóstico de enfermedad pulmonar obstructiva crónica [Validation of the Spanish version of the Chronic Obstructive Pulmonary Disease-Population Screener (COPD-PS). Its usefulness and that of FEV₁/FEV₆ for the diagnosis of COPD]. Med Clin (Barc). 2012;139(12):522-530. https://doi.org/10.1016/j.medcli.2011.06.022

5. Du M, Hu H, Zhang L, et al. China county based COPD screening and cost-effectiveness analysis. Ann Palliat Med. 2021;10(4):4652-4660. https://doi.org/10.21037/apm-21-812