Background/Aims: Asthma is characterized by chronic inflammation. Inhaled corticosteroids (ICS) remain the cornerstone of anti-inflammatory therapy, targeting both the large and small airways. Methods: This randomized open-label crossover trial included 30 patients receiving step 3 inhaled medication according to the Global Initiative for Asthma (GINA). Patients received beclomethasone/formoterol (BDP/F) for maintenance and reliever therapy for 6 weeks, followed by budesonide/formoterol (BUD/F) for 6 weeks, or vice versa, with a 4-week washout period in between. Assessments at each visit included the Asthma Control Test (ACT), Asthma Control Questionnaire, Quality of Life Questionnaire for Adult Korean Asthmatics, and pulmonary function test. The primary endpoint was the change in forced expiratory flow between 25% and 75% of vital capacity (FEF25–75% pred). Results: Twenty-four patients (15 females, mean age 39.3 years) completed the study. The changes in FEF25–75% pred were comparable between BDP/F and BUD/F (5.79 ± 38.34 vs. -1.36 ± 14.93, p = 0.399). No significant differences were observed between the BDP/F and BUD/F groups in terms of improvement in asthma control or quality of life. However, in the subgroup of patients with positive methacholine bronchial provocation tests, BDP/F significantly improved ACT scores compared to BUD/F (0.92 ± 2.25 vs. -1.31 ± 3.04, p = 0.044). Conclusions Our study demonstrated that extrafine ICS treatment provided no significant advantage over non-extrafine ICS in improving small airway obstruction or overall asthma control in moderate asthma. This suggests that factors other than particle size may contribute to treatment outcomes.

Background/Aims: Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing. Methods: In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs). Results: In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively. Conclusions Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.

Purpose: While fluoropyrimidine-based chemotherapy regimens are recommended second-line treatment for patients with advanced biliary tract cancer (BTC), there have been no studies comparing different regimens head-to-head. Materials and Methods: We performed individual patient-level meta-analysis based on data from the intention-to-treat population of the phase 2b NIFTY trial (liposomal irinotecan [nal-IRI] plus fluorouracil and leucovorin [5-FU/LV] vs. 5-FU/LV; NCT03542508) and the phase 2 FIReFOX trial (modified oxaliplatin plus 5-FU/LV [mFOLFOX] vs. modified irinotecan plus 5-FU/LV [mFOLFIRI]; NCT03464968). Pairwise log-rank tests and multivariable analysis using Cox proportional hazards modeling with shared frailty to account for the trial's effect were used to compare overall survival (OS) between regimens. Results: A total of 277 patients were included. The nal-IRI plus 5-FU/LV group (n=88) showed significantly better OS compared to the mFOLFOX group (n=49, pairwise log-rank, p=0.02), and mFOLFIRI group (n=50, p=0.03). Multivariable analysis showed consistent trends in OS with adjusted hazard ratios of 1.39 (mFOLFOX vs. nal-IRI plus 5-FU/LV: 95% confidence interval [CI], 0.93 to 2.07; p=0.11) and 1.36 (mFOLFIRI vs. nal-IRI plus 5-FU/LV: 95% CI, 0.92 to 2.03; p=0.13), respectively. Compared to the 5-FU/LV group, the mFOLFOX group and the mFOLFIRI group did not show differences in terms of OS (pairwise log-rank p=0.83 and p=0.58, respectively). The nal-IRI plus 5-FU/LV group experienced more frequent diarrhea, while the mFOLFOX group experienced peripheral neuropathy. Conclusion Nal-IRI plus 5-FU/LV showed favorable survival outcomes compared to mFOLFOX, mFOLFIRI, or 5-FU/LV. The safety profiles of these regimens should be considered along with efficacy.

Background/Aims: Asthma is characterized by chronic inflammation. Inhaled corticosteroids (ICS) remain the cornerstone of anti-inflammatory therapy, targeting both the large and small airways. Methods: This randomized open-label crossover trial included 30 patients receiving step 3 inhaled medication according to the Global Initiative for Asthma (GINA). Patients received beclomethasone/formoterol (BDP/F) for maintenance and reliever therapy for 6 weeks, followed by budesonide/formoterol (BUD/F) for 6 weeks, or vice versa, with a 4-week washout period in between. Assessments at each visit included the Asthma Control Test (ACT), Asthma Control Questionnaire, Quality of Life Questionnaire for Adult Korean Asthmatics, and pulmonary function test. The primary endpoint was the change in forced expiratory flow between 25% and 75% of vital capacity (FEF25–75% pred). Results: Twenty-four patients (15 females, mean age 39.3 years) completed the study. The changes in FEF25–75% pred were comparable between BDP/F and BUD/F (5.79 ± 38.34 vs. -1.36 ± 14.93, p = 0.399). No significant differences were observed between the BDP/F and BUD/F groups in terms of improvement in asthma control or quality of life. However, in the subgroup of patients with positive methacholine bronchial provocation tests, BDP/F significantly improved ACT scores compared to BUD/F (0.92 ± 2.25 vs. -1.31 ± 3.04, p = 0.044). Conclusions Our study demonstrated that extrafine ICS treatment provided no significant advantage over non-extrafine ICS in improving small airway obstruction or overall asthma control in moderate asthma. This suggests that factors other than particle size may contribute to treatment outcomes.

Background/Aims: Asthma is characterized by chronic inflammation. Inhaled corticosteroids (ICS) remain the cornerstone of anti-inflammatory therapy, targeting both the large and small airways. Methods: This randomized open-label crossover trial included 30 patients receiving step 3 inhaled medication according to the Global Initiative for Asthma (GINA). Patients received beclomethasone/formoterol (BDP/F) for maintenance and reliever therapy for 6 weeks, followed by budesonide/formoterol (BUD/F) for 6 weeks, or vice versa, with a 4-week washout period in between. Assessments at each visit included the Asthma Control Test (ACT), Asthma Control Questionnaire, Quality of Life Questionnaire for Adult Korean Asthmatics, and pulmonary function test. The primary endpoint was the change in forced expiratory flow between 25% and 75% of vital capacity (FEF25–75% pred). Results: Twenty-four patients (15 females, mean age 39.3 years) completed the study. The changes in FEF25–75% pred were comparable between BDP/F and BUD/F (5.79 ± 38.34 vs. -1.36 ± 14.93, p = 0.399). No significant differences were observed between the BDP/F and BUD/F groups in terms of improvement in asthma control or quality of life. However, in the subgroup of patients with positive methacholine bronchial provocation tests, BDP/F significantly improved ACT scores compared to BUD/F (0.92 ± 2.25 vs. -1.31 ± 3.04, p = 0.044). Conclusions Our study demonstrated that extrafine ICS treatment provided no significant advantage over non-extrafine ICS in improving small airway obstruction or overall asthma control in moderate asthma. This suggests that factors other than particle size may contribute to treatment outcomes.

Purpose: While fluoropyrimidine-based chemotherapy regimens are recommended second-line treatment for patients with advanced biliary tract cancer (BTC), there have been no studies comparing different regimens head-to-head. Materials and Methods: We performed individual patient-level meta-analysis based on data from the intention-to-treat population of the phase 2b NIFTY trial (liposomal irinotecan [nal-IRI] plus fluorouracil and leucovorin [5-FU/LV] vs. 5-FU/LV; NCT03542508) and the phase 2 FIReFOX trial (modified oxaliplatin plus 5-FU/LV [mFOLFOX] vs. modified irinotecan plus 5-FU/LV [mFOLFIRI]; NCT03464968). Pairwise log-rank tests and multivariable analysis using Cox proportional hazards modeling with shared frailty to account for the trial's effect were used to compare overall survival (OS) between regimens. Results: A total of 277 patients were included. The nal-IRI plus 5-FU/LV group (n=88) showed significantly better OS compared to the mFOLFOX group (n=49, pairwise log-rank, p=0.02), and mFOLFIRI group (n=50, p=0.03). Multivariable analysis showed consistent trends in OS with adjusted hazard ratios of 1.39 (mFOLFOX vs. nal-IRI plus 5-FU/LV: 95% confidence interval [CI], 0.93 to 2.07; p=0.11) and 1.36 (mFOLFIRI vs. nal-IRI plus 5-FU/LV: 95% CI, 0.92 to 2.03; p=0.13), respectively. Compared to the 5-FU/LV group, the mFOLFOX group and the mFOLFIRI group did not show differences in terms of OS (pairwise log-rank p=0.83 and p=0.58, respectively). The nal-IRI plus 5-FU/LV group experienced more frequent diarrhea, while the mFOLFOX group experienced peripheral neuropathy. Conclusion Nal-IRI plus 5-FU/LV showed favorable survival outcomes compared to mFOLFOX, mFOLFIRI, or 5-FU/LV. The safety profiles of these regimens should be considered along with efficacy.

Background/Aims: Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing. Methods: In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs). Results: In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively. Conclusions Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.

Background/Aims: Asthma is characterized by chronic inflammation. Inhaled corticosteroids (ICS) remain the cornerstone of anti-inflammatory therapy, targeting both the large and small airways. Methods: This randomized open-label crossover trial included 30 patients receiving step 3 inhaled medication according to the Global Initiative for Asthma (GINA). Patients received beclomethasone/formoterol (BDP/F) for maintenance and reliever therapy for 6 weeks, followed by budesonide/formoterol (BUD/F) for 6 weeks, or vice versa, with a 4-week washout period in between. Assessments at each visit included the Asthma Control Test (ACT), Asthma Control Questionnaire, Quality of Life Questionnaire for Adult Korean Asthmatics, and pulmonary function test. The primary endpoint was the change in forced expiratory flow between 25% and 75% of vital capacity (FEF25–75% pred). Results: Twenty-four patients (15 females, mean age 39.3 years) completed the study. The changes in FEF25–75% pred were comparable between BDP/F and BUD/F (5.79 ± 38.34 vs. -1.36 ± 14.93, p = 0.399). No significant differences were observed between the BDP/F and BUD/F groups in terms of improvement in asthma control or quality of life. However, in the subgroup of patients with positive methacholine bronchial provocation tests, BDP/F significantly improved ACT scores compared to BUD/F (0.92 ± 2.25 vs. -1.31 ± 3.04, p = 0.044). Conclusions Our study demonstrated that extrafine ICS treatment provided no significant advantage over non-extrafine ICS in improving small airway obstruction or overall asthma control in moderate asthma. This suggests that factors other than particle size may contribute to treatment outcomes.

Purpose: While fluoropyrimidine-based chemotherapy regimens are recommended second-line treatment for patients with advanced biliary tract cancer (BTC), there have been no studies comparing different regimens head-to-head. Materials and Methods: We performed individual patient-level meta-analysis based on data from the intention-to-treat population of the phase 2b NIFTY trial (liposomal irinotecan [nal-IRI] plus fluorouracil and leucovorin [5-FU/LV] vs. 5-FU/LV; NCT03542508) and the phase 2 FIReFOX trial (modified oxaliplatin plus 5-FU/LV [mFOLFOX] vs. modified irinotecan plus 5-FU/LV [mFOLFIRI]; NCT03464968). Pairwise log-rank tests and multivariable analysis using Cox proportional hazards modeling with shared frailty to account for the trial's effect were used to compare overall survival (OS) between regimens. Results: A total of 277 patients were included. The nal-IRI plus 5-FU/LV group (n=88) showed significantly better OS compared to the mFOLFOX group (n=49, pairwise log-rank, p=0.02), and mFOLFIRI group (n=50, p=0.03). Multivariable analysis showed consistent trends in OS with adjusted hazard ratios of 1.39 (mFOLFOX vs. nal-IRI plus 5-FU/LV: 95% confidence interval [CI], 0.93 to 2.07; p=0.11) and 1.36 (mFOLFIRI vs. nal-IRI plus 5-FU/LV: 95% CI, 0.92 to 2.03; p=0.13), respectively. Compared to the 5-FU/LV group, the mFOLFOX group and the mFOLFIRI group did not show differences in terms of OS (pairwise log-rank p=0.83 and p=0.58, respectively). The nal-IRI plus 5-FU/LV group experienced more frequent diarrhea, while the mFOLFOX group experienced peripheral neuropathy. Conclusion Nal-IRI plus 5-FU/LV showed favorable survival outcomes compared to mFOLFOX, mFOLFIRI, or 5-FU/LV. The safety profiles of these regimens should be considered along with efficacy.

Background/Aims: Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing. Methods: In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs). Results: In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively. Conclusions Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.