NCT07533565

A Pilot Study of Mirabegron and Montelukast in Cirrhotic Patients

A Pilot Interventional Study to Evaluate the Safety and Tolerability of Mirabegron and Montelukast in Patients With Liver Cirrhosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Kafrelsheikh University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study was a prospective, interventional, pilot clinical study conducted over 3 months on Egyptian cirrhotic patients with overactive bladder and asthma. Adult patients aged \>18 years with confirmed liver cirrhosis, concomitant overactive bladder and asthma were eligible for inclusion. Patients were experienced acute episodes of disease associated with deterioration of hepatic function within 2 months prior to screening, and received concomitant medications known to strongly interact with the study drugs were excluded. In part 1: Mirabegron dosing was determined based on Simcyp -generated predictions and clinical assessment. 100mg,50 mg, 50 mg, and 25 mg received by control, CP-A, CP-B, and CP-C cirrhosis patients, respectively, orally once daily. In part 2: Montelukast dosing was determined based on Simcyp-generated predictions and clinical assessment. 10mg 5 mg,5 mg, and 4 mg received by control, and CP-A, CP-B, and CP-C cirrhosis patients, respectively, orally once daily. 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 \[ALT\],a aspartate aminotransferase \[AST\]), kidney function tests (serum creatinine and blood urea nitrogen \[BUN\]),and CBC.

Conditions

• Cirrhosis
• Asthma

Interventions

Type	Name	Description
DRUG	Mirabegron 100 mg	Mirabegron is a sympathomimetic beta-3 adrenergic receptor agonist used to relax the smooth muscle of the bladder in the treatment of urinary frequency and incontinence.
DRUG	Mirabegron 50mg	Mirabegron is a sympathomimetic beta-3 adrenergic receptor agonist used to relax the smooth muscle of the bladder in the treatment of urinary frequency and incontinence.
DRUG	Mirabegron 50mg	Mirabegron is a sympathomimetic beta-3 adrenergic receptor agonist used to relax the smooth muscle of the bladder in the treatment of urinary frequency and incontinence.
DRUG	mirabegron 25 mg	Mirabegron is a sympathomimetic beta-3 adrenergic receptor agonist used to relax the smooth muscle of the bladder in the treatment of urinary frequency and incontinence.
DRUG	Montelukast 10 mg	Montelukast is a leukotriene receptor antagonist used as part of an asthma therapy regimen, to prevent exercise induced bronchoconstriction, and to treat seasonal allergic rhinitis.
DRUG	montelukast (5mg QD)	Montelukast is a leukotriene receptor antagonist used as part of an asthma therapy regimen, to prevent exercise induced bronchoconstriction, and to treat seasonal allergic rhinitis.
DRUG	montelukast 4 mg granule	Montelukast is a leukotriene receptor antagonist used as part of an asthma therapy regimen, to prevent exercise induced bronchoconstriction, and to treat seasonal allergic rhinitis.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-07-01
• Completion: 2025-10-01
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: Egypt