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A Pilot Study of Mirabegron and Montelukast in Cirrhotic Patients

CompletedPhase 4

Sponsor: Kafrelsheikh University

Conditions: Cirrhosis, Asthma

Interventions: Mirabegron 100 mg, Mirabegron 50mg, Mirabegron 50mg, mirabegron 25 mg, Montelukast 10 mg

Countries: Egypt

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 90 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

* Patients with kidney disorder or dialysis
* Pregnancy

Locations (1)

Cairo, Kafr el-Sheikh Governorate, Egypt