The TOPIC Study: Treatment of Pneumocystitis in COPD

William Beaumont Hospitals is starting a new clinical trial of Treatment of Pneumocystitis in COPD (the TOPIC Study).

Chronic obstructive pulmonary disease (COPD) is a progressive lung disease associated with chronic inflammation in the airways and lung, resulting in significant morbidity and mortality worldwide. Smoking is the primary risk factor for development of COPD and progression of the disease is associated with acute exacerbations of COPD (AECOPD) that can be triggered by acute bacterial or viral airway infections or can occur independently of infection. AECOPD can lead to hospitalization, progression of the disease, and mortality. COPD affects an estimated 11.7% of the world population and was the third leading cause of death worldwide in 2019.

This study is a randomized, double-blinded and placebo controlled study to determine if treating PJ in AECOPD with confirmed PJ colonization has a beneficial clinical impact. As a secondary goal of the study, it will be determined if TMP-SMX can decolonize these patients and if the decolonization is durable for at least 3 months. 

The goal of this study is to determine if treating PJ in AECOPD with confirmed PJ colonization has a beneficial clinical impact. As a secondary goal of the study, it will be determined if TMP-SMX can decolonize these patients and if the decolonization is durable for at least 3 months. Participants will be randomized in a 1:1 ratio to one of two groups. Group #1 will receive a suspension with the equivalent of one double strength (DS) TMP-SMX by mouth every 12 hours. Group #2 will received a suspension with placebo by mouth every 12 hours.

The clinical trial starts in July 2022 and will continue throughout August 2023.

Improvement in the COPD Assessment Test will be primary outcome measure. Total score on the COPD Assessment Test (CAT); the test has a score of 0 (minimum) - 40 (maximum); a lower score means a better outcomes and a higher score means a worse outcome.

For more details: https://ichgcp.net/clinical-trials-registry/NCT05418777 or https://clinicaltrials.gov/ct2/show/NCT05418777.