Introduction: Home-based spirometry has emerged as a potential component of decentralized clinical trials (DCTs) in respiratory medicine, but its real-world feasibility in patients with chronic obstructive pulmonary disease (COPD) and other respiratory diseases remains insufficiently characterized. This study evaluated the feasibility of remote pulmonary function monitoring using a portable spirometer and mobile application in adults with COPD or other respiratory diseases. Methods: This exploratory single-arm study enrolled adults aged 19 years or older with COPD or other respiratory diseases. Participants were asked to perform home-based spirometry at six prespecified time points (Days 15, 29, 43, 57, 71, and 85). Feasibility was assessed using visit-level and participant-level adherence, spirometry quality grades, and patient-reported usability and satisfaction. Participants completing at least 5 of 6 scheduled measurements were classified as the high-adherence group; this cut-off was an operational, study-specific definition. Results: A total of 30 participants were enrolled (19 with chronic obstructive pulmonary disease, 5 with asthma, 2 with asthma–COPD overlap, and 4 with other respiratory conditions), and 23 completed the study. Visit-level completion rates declined over time, from 88.5% on Day 15 to 47.8% on Day 71 and 56.5% on Day 85. Nine participants completed all six measurements, while 13 completed at least five. Portable spirometry quality showed variability across visits, with both high-quality and low-quality measurements observed. Compared with the low-adherence group, the high-adherence group reported significantly higher scores for convenience, communication with the research team, overall satisfaction, willingness to participate in future telemedicine-based trials, device training adequacy, ease of device use, and application usability. Conclusions: Home-based spirometry may be a useful decentralized trial component in patients with COPD and other respiratory diseases; however, the decline in adherence over time and the variability in measurement quality indicate that substantial operational refinement is needed before broader implementation. Because no feasibility threshold was prespecified, no concurrent laboratory spirometry comparison was performed, and the study population was diagnostically heterogeneous, these findings are exploratory and address operational feasibility rather than measurement validity.

Background/Objectives: Oral donepezil, an acetylcholinesterase (AChE) inhibitor for Alzheimer’s disease, faces adherence challenges. Long-acting injectable (LAI) formulations like GB-5001 aim to enhance adherence by reducing dosing frequency. This Phase 1, open-label, active-controlled, dose-escalation study evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GB-5001 in healthy male adults. Methods: Participants were assigned to cohorts receiving GB-5001A or GB-5001D (LAI formulations) via intramuscular (IM) or subcutaneous (SC) injection, or oral Aricept^®. Safety, PK, and PD (AChE inhibition) were assessed. The influence of CYP2D6 phenotype was explored, and modeling/simulation was performed. Results: Fifty healthy male participants completed the study. After IM administration, GB-5001A (70 mg, 140 mg, 280 mg) showed dose-dependent increases in exposure (AUC_inf and C_max), resulting in significantly extended exposure compared to oral Aricept^® 10 mg. No serious adverse events were reported; the most common AEs were mild injection site reactions, which occurred in all treatment groups except the GB-5001A IM 70 mg group and the Aricept group. GB-5001A also demonstrated sustained AChE inhibition. Conclusions: GB-5001A, an LAI donepezil, showed favorable safety, dose-proportional PK, and sustained plasma exposure. It achieved a 3–4-fold longer half-life than oral donepezil. These findings, supported by modeling, highlight GB-5001A’s potential as a once-monthly IM alternative for Alzheimer’s disease treatment.

CT‐P13, a biosimilar of infliximab, is used to treat inflammatory diseases that arise from immune system complications, resulting in excessive and persistent inflammation. The subcutaneous (SC) formulation of CT‐P13 overcomes the drawback of prolonged administration associated with the intravenous (IV) infliximab biosimilar, necessitating autoinjector (AI) administration. This randomized, open‐label, two‐arm, parallel‐group, single‐dose clinical pharmacology study aimed to evaluate the pharmacokinetics (PK) and safety of CT‐P13 SC administration via AI compared with the existing pre‐filled syringe (PFS) method. A total of 147 healthy participants were randomized into two groups, of which 139 completed the study. Blood samples were collected from before CT‐P13 SC administration to 2016 h after the start of the administration. Serum concentrations were analyzed using the Meso Scale Discovery electrochemiluminescence method. Geometric mean ratios (90% confidence interval) of the AUC_inf (areas under the concentration–time curve from zero to infinity) and C_max (The maximum serum concentration) for CT‐P13 SC AI versus CT‐P13 SC PFS groups, were 94.15% (85.02%–104.26%), 92.48% (84.66%–101.01%), respectively. CT‐P13 SC AI and CT‐P13 SC PFS achieved comparable PK because the 90% CI was within the predefined equivalence margin. At the end of the study, immunogenicity results revealed that 70 (97.22%) and 73 (98.65%) participants tested positive for anti‐drug antibody (ADA) in the CT‐P13 SC AI and CT‐P13 SC PFS groups, respectively. They were tested positive for neutralizing antibodies. No other significant safety differences were observed between the treatment groups. In conclusion, both administrations demonstrated PK equivalence and were both safe and well‐tolerated.

Kim CJ, et al. Transl Clin Pharmacol. 2025 Mar;33(1):19-26. https://doi.org/10.12793/tcp.2025.33.e2