Response to Long Acting Bronchodilators by STaging of Airflow Obstruction by the Ratio (STAR) versus Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages of Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is the name for a group of lung conditions that results in shortness of breath and long-term cough. COPD is a broad term that includes emphysema (damage to the air sacs in the lungs) and chronic bronchitis (long-term inflammation of the airways). COPD is most often associated with cigarette smoking, but it is increasingly recognized that people who have never smoked can also develop COPD. It most commonly affects middle-aged or older adults. COPD does not have any cure, and treatment is mostly aimed at decreasing symptom burden. Treatment involves prescribing inhalers that are bronchodilators (medications that open up the airways and hence ease breathing) and inhaled corticosteroids (medications which decrease inflammation in the lungs). Patients with symptoms are treated with inhaled long-acting bronchodilators such as tiotropium to help improve shortness of breath, flareups or exacerbations (worsening of symptoms), quality of life, and lung function.

Patients with COPD are classified into groups based on how severe their symptoms are and how often they experience flare-ups, which helps doctors decide which medications to prescribe. However, disease severity is often categorized using a measure of lung function called the forced expiratory volume in 1 second (FEV1) test, which may not always guide treatment decisions effectively. To improve this, we developed a new staging system called STaging of Airflow obstruction by Ratio (STAR), which uses a different measurement to predict the risk of death, quality of life, and lung function decline more accurately.

In this study, we aim to combine two studies (Understanding Potential Long-term Impacts on Function with Tiotropium [UPLIFT] requested here) with TIE-COPD so we have patients with the entire spectrum of severity and evaluate whether there are differences in responses to Tiotropium (compared with placebo) at 6 months and 12 months with respect to changes in lung function, quality of life, and shortness of breath.

Our findings could impact how disease severity stages are evaluated in COPD and increase the value of staging.