A Pilot Study of Mirabegron and Montelukast in Cirrhotic Patients

NCT07533565 | Completed Phase 4 DMC

• 1 other identifier: KFSIRB200-211/2
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cirrhosis; Asthma

Keywords

Cirrhosis; Over active bladder; PBPK

Outcome Measures

Primary Outcomes (1)

• Change in number of urinary incontinence episodes per 24 hours

  The primary outcome will be the change from baseline in the number of urinary incontinence episodes recorded over 24 hours, assessed before and after treatment in the control and treatment groups. Urinary incontinence episodes will be documented using a 24-hour bladder diary.

  3 months

Secondary Outcomes (1)

• Monitoring of Adverse Effects

  3 months

Study Arms (8)

Control -Standard Dose Mirabegron

ACTIVE COMPARATOR

Mirabegron 100 mg

Drug: Mirabegron 100 mg

Mirabegron : Child-Pugh A

EXPERIMENTAL

Mirabegron 50 mg

Drug: Mirabegron 50mg

Mirabegron: Child-Pugh B

EXPERIMENTAL

Mirabegron 50 mg

Drug: Mirabegron 50mg

Mirabegron: Child-Pugh C

EXPERIMENTAL

Mirabegron 25 mg

Drug: mirabegron 25 mg

Control -Standard Dose Montelukast

ACTIVE COMPARATOR

Montelukast 10 mg

Drug: Montelukast 10 mg

Montelukast: Child-Pugh A

EXPERIMENTAL

Montelukast 5 mg

Drug: montelukast (5mg QD)

Montelukast: Child-Pugh B

EXPERIMENTAL

Montelukast 5 mg

Drug: montelukast (5mg QD)

Montelukast: Child-Pugh C

EXPERIMENTAL

Montelukast 4 mg

Drug: montelukast 4 mg granule

Interventions

Mirabegron 100 mg DRUG

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.

Control -Standard Dose Mirabegron

Mirabegron 50mg DRUG

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.

Mirabegron : Child-Pugh A

mirabegron 25 mg DRUG

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.

Mirabegron: Child-Pugh C

Montelukast 10 mg DRUG

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.

Control -Standard Dose Montelukast

montelukast (5mg QD) DRUG

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.

Montelukast: Child-Pugh A; Montelukast: Child-Pugh B

montelukast 4 mg granule DRUG

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.

Montelukast: Child-Pugh C

Eligibility Criteria

• Age: 18 Years - 90 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of hepatic impairment. Diagnosed with overactive bladder. Presence of asthma. Age of patients \> 18 years.

You may not qualify if:

• Patients with kidney disorder or dialysis
• Pregnancy

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafr El-Sheikh University

Cairo, Kafr el-Sheikh Governorate, 33511, Egypt

Location

Related Links

• Related Info

MeSH Terms

Conditions

Fibrosis; Asthma

Interventions

mirabegron; montelukast

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Noha Mahmoud ELkhodary, Associate Professor

  Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh University

  STUDY DIRECTOR

• Aya Emad Fouda, MSc in Clinical Pharmacy

  Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: Parallel-assignment interventional study to compare dose-modified of mirabegron and montelukast across Child-Pugh classes with standard-dose controls."

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 16, 2026
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

EG (1)