COPD
Treatment of Pneumocystitis in COPD (the TOPIC Study): NCT05418777
In this randomized, double-blind, placebo-controlled study, the primary outcome will be to determine if treating Pneumocystis jirovecii in acute exacerbations of COPD with confirmed P. jirovecii colonization has a beneficial clinical impact. As a secondary goal of the study, it will be determined if the addition of trimethoprim-sulfamethoxazole (TMP-SMX) to standard of care can decolonize these patients and if the decolonization is durable for at least 3 months.
A total of 30 participants aged 40-89 years will be randomized to receive either a suspension with the equivalent of one double-strength TMP-SMX or a suspension with placebo by mouth every 12 hours. If the participant is discharged prior to completing the 10-day course of the medication, they will be sent home with the remaining study medication and a medication diary which will be collected.
Location: William Beaumont Hospital, Royal Oak, Mich.
Sponsor: William Beaumont Hospitals
Contact: matthew.sims@beaumont.edu
Study start date: July 2022
Expected completion Date: August 2023
Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction (SAVED-1): NCT05257681
This study is intended to be a pilot prospective controlled clinical trial to evaluate the potential role of a lung fissure completion with pleural adhesiolysis strategy (experimental intervention) in severe emphysema/COPD patients with failed bronchoscopic lung volume reduction via the use of endobronchial valves therapy.
In 20 select patients (ages 40-75 years), the lung fissure completion with adhesiolysis strategy will be performed by video-assisted thoracoscopic surgery guided stapling along the lung fissures to reduce collateral ventilation with adhesions removal. The primary outcomes will be to prove that interlobar fissures can be completed to at least 95% in severe emphysema patients with previously failed bronchoscopic lung volume reduction over a 2 year period and the occurrence of adverse events in that period. The surgery will be considered feasible if the target inter-lobar fissure can be completed in at least 90% of the patients enrolled. Secondary outcomes over 2 years will include quality of life improvement and the percentage of patients with significant changes in pulmonary function testing.
Location: Beth Deaconess Medical Center, Boston
Sponsor: Beth Israel Deaconess Medical Center
Contact: amajid@bidmc.harvard.edu
Study start date: May 2022
Expected completion Date: May 2024