CirrhosisPhase 4NCT07533565
A Pilot Study of Mirabegron and Montelukast in Cirrhotic Patients
A Phase 4 study testing Mirabegron 100 mg, Mirabegron 50mg and mirabegron 25 mg in people with Cirrhosis and Asthma, run by Kafrelsheikh University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- What is being tested?
- Mirabegron 100 mg, Mirabegron 50mg and mirabegron 25 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of hepatic impairment. Diagnosed with overactive bladder. Presence of asthma. Age of patients > 18 years.
Who cannot join
- Patients with kidney disorder or dialysis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Interventional Study to Evaluate the Safety and Tolerability of Mirabegron and Montelukast in Patients With Liver Cirrhosis
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.
Read the 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.
- Being tested
- Mirabegron 100 mg, Mirabegron 50mg, mirabegron 25 mg, Montelukast 10 mg, montelukast (5mg QD)
- Keywords
- Cirrhosis, Over active bladder, PBPK
- Medical subject headings
- Fibrosis, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirabegron 100 mgDrug
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 50mgDrug
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 50mgDrug
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 25 mgDrug
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.
Montelukast 10 mgDrug
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 (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 4 mg granuleDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Control -Standard Dose Mirabegron | Active comparator | Mirabegron 100 mg Receives: Drug: Mirabegron 100 mg |
| Mirabegron : Child-Pugh A | Experimental | Mirabegron 50 mg Receives: Drug: Mirabegron 50mg |
| Mirabegron: Child-Pugh B | Experimental | Mirabegron 50 mg Receives: Drug: Mirabegron 50mg |
| Mirabegron: Child-Pugh C | Experimental | Mirabegron 25 mg Receives: Drug: mirabegron 25 mg |
| Control -Standard Dose Montelukast | Active comparator | Montelukast 10 mg Receives: Drug: Montelukast 10 mg |
| Montelukast: Child-Pugh A | Experimental | Montelukast 5 mg Receives: Drug: montelukast (5mg QD) |
| Montelukast: Child-Pugh B | Experimental | Montelukast 5 mg Receives: Drug: montelukast (5mg QD) |
| Montelukast: Child-Pugh C | Experimental | Montelukast 4 mg Receives: Drug: montelukast 4 mg granule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
Monitoring of Adverse Effects
Adverse effects including headache, dry mouth, abdominal pain, dizziness, hypertension, urinary tract infection will be recorded
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Jul 2024
- Primary completion1 Jul 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-assignment interventional study to compare dose-modified of mirabegron and montelukast across Child-Pugh classes with standard-dose controls."
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Emad Nasr Mohammed Fouda, Kafrelsheikh University
- Investigators
- Noha Mahmoud ELkhodary, Associate Professor, Study director, Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh UniversityAya Emad Fouda, MSc in Clinical Pharmacy, Principal investigator, Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533565
- Sponsor's protocol ID
- KFSIRB200-211/2
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Interventional Study to Evaluate the Safety and Tolerability of Mirabegron and Montelukast in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT07533565
- Acronym / sponsor ID
- KFSIRB200-211/2
- Keywords
- Cirrhosis, Over active bladder, PBPK
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Parallel-assignment interventional study to compare dose-modified of mirabegron and montelukast across Child-Pugh classes with standard-dose controls."
| Arm | Type | Receives |
|---|---|---|
| Control -Standard Dose Mirabegron | Active comparator | Drug: Mirabegron 100 mgMirabegron 100 mg |
| Mirabegron : Child-Pugh A | Experimental | Drug: Mirabegron 50mgMirabegron 50 mg |
| Mirabegron: Child-Pugh B | Experimental | Drug: Mirabegron 50mgMirabegron 50 mg |
| Mirabegron: Child-Pugh C | Experimental | Drug: mirabegron 25 mgMirabegron 25 mg |
| Control -Standard Dose Montelukast | Active comparator | Drug: Montelukast 10 mgMontelukast 10 mg |
| Montelukast: Child-Pugh A | Experimental | Drug: montelukast (5mg QD)Montelukast 5 mg |
| Montelukast: Child-Pugh B | Experimental | Drug: montelukast (5mg QD)Montelukast 5 mg |
| Montelukast: Child-Pugh C | Experimental | Drug: montelukast 4 mg granuleMontelukast 4 mg |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of hepatic impairment. Diagnosed with overactive bladder. Presence of asthma. Age of patients > 18 years.
Key exclusion criteria (2 listed)
- Patients with kidney disorder or dialysis
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirabegron 100 mgMirabegron 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 | Control -Standard Dose Mirabegron |
| Mirabegron 50mgMirabegron 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 : Child-Pugh A |
| Mirabegron 50mgMirabegron 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: Child-Pugh B |
| mirabegron 25 mgMirabegron 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: Child-Pugh C |
| Montelukast 10 mgMontelukast 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 | Control -Standard Dose Montelukast |
| 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: Child-Pugh A, Montelukast: Child-Pugh B |
| montelukast 4 mg granuleMontelukast 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: Child-Pugh C |
Primary outcome
Change in number of urinary incontinence episodes per 24 hours
Time frame: 3 months
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.
1 secondary outcome
Monitoring of Adverse Effects
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noha Mahmoud ELkhodary, Associate Professor study director
Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh University
Aya Emad Fouda, MSc in Clinical Pharmacy principal investigator
Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mirabegron 100 mg, Mirabegron 50mg and mirabegron 25 mg in people with Cirrhosis and Asthma, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of urinary incontinence episodes per 24 hours (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.