A Pilot Study of Mirabegron and Montelukast in Cirrhotic Patients

Summary

This study was a prospective, interventional, pilot clinical study conducted over 3 months on cirrhotic patients with overactive bladder and asthma, evaluating the real-world applicability of selected PBPK-guided dosing regimens. Patients were stratified according to Child-Pugh class (CP-A, CP-B, and CP-C) and administered mirabegron and montelukast at doses corresponding to the closest commercially available strengths to Simcyp®-optimized doses. Clinical evaluation included number of incontinence episodes, number of micturation, volume voided per micturation, cough, and wheezing. Routine laboratory investigations were conducted to assess efficacy and safety and included liver function tests (serum albumin, total bilirubin, alanine aminotransferase \[ALT\], and aspartate aminotransferase \[AST\]), kidney function tests (serum creatinine and blood urea nitrogen \[BUN\]), and CBC.

Timeline

Start

2024-07-01

Primary completion

2025-07-01

Completion

2025-10-01

Drugs

Indications