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Angiotensin II Receptor Blocker
Losartan for Cystic Fibrosis
Phase < 1
Recruiting
Led By Matthias Salathe, MD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
CF patients with any known mutation combination not on CFTR augmentation therapy
≥18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will study whether losartan can help improve mucus clearance in patients with cystic fibrosis who cannot take current CFTR rescue therapies.
Who is the study for?
Adults over 18 with cystic fibrosis not treated with CFTR therapy can join. They should have mild to moderate lung disease, be able to produce sputum daily, and have an FEV1 ≥40% of predicted. Participants need a negative COVID-19 test before testing, must not smoke or have quit for at least a year, and females must use strict birth control.Check my eligibility
What is being tested?
The trial is studying the effect of Losartan on mucociliary clearance in cystic fibrosis patients ineligible for CFTR therapies. It's a small-scale proof of concept study designed to understand how this medication might help clear mucus from the lungs.See study design
What are the potential side effects?
Losartan may cause dizziness due to low blood pressure, increased potassium levels which can affect heart rhythm, kidney function changes, or allergic reactions if there's intolerance to ARBs (angiotensin receptor blockers).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have cystic fibrosis and am not on CFTR therapy.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improvement of mucociliary clearance ( MCC) and cough clearance (CC)
Secondary outcome measures
Decrease of inflammatory markers
Improvement on pulmonary function tests (in %predicted)
Improvement on pulmonary function tests (in L)
+1 moreSide effects data
From 2021 Phase 4 trial • 227 Patients • NCT0218812143%
Laboratory values outside normal range
23%
Psychiatric Hospitalization
6%
Medical Hospitalization
2%
Elevated creatine kinase level
1%
Muscle pain
1%
Hypotension
1%
Dehydration
1%
Leukemia
1%
Placed on Lithium while on Losartan
100%
80%
60%
40%
20%
0%
Study treatment Arm
Statin and/or Angiotensin Receptor Blocker
Usual Treatment
Trial Design
1Treatment groups
Experimental Treatment
Group I: losartanExperimental Treatment1 Intervention
a daily dose of 50 mg losartan for 7 days (for tolerability). Then, the losartan dose will be increased to 100 mg daily for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Losartan
2003
Completed Phase 4
~3000
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
461 Previous Clinical Trials
169,141 Total Patients Enrolled
8 Trials studying Cystic Fibrosis
247 Patients Enrolled for Cystic Fibrosis
Matthias Salathe, MDPrincipal InvestigatorUniversity of Kansas
1 Previous Clinical Trials
7 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
7 Patients Enrolled for Cystic Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung condition is considered mild to moderate.You are not able to do the breathing tests required for the study.I regularly use NSAIDs, potassium supplements, aliskiren, or am on anticoagulation therapy.You need to have a negative COVID-19 test within 3 days before the test for the clinical trial.I am a current or former smoker who quit less than a year ago or have smoked more than 10 pack-years.I do not have major health issues that could affect my participation in the study.I use antibiotics occasionally or have completed 2 cycles if on chronic treatment.You can't tolerate angiotensin receptor blockers (ARB).I am taking medication for my blood pressure.I have had surgery in my chest area before.You need to have a certain level of lung function, called FEV1, to be eligible for the study.I have cystic fibrosis and am not on CFTR therapy.Your oxygen level needs to be higher than 92% when measured with a pulse oximeter.I have not taken oral steroids in the last 6 weeks.I am being treated for a mycobacterial infection.My blood pressure is high and untreated.I am 18 years old or older.I have severe breathing issues, need oxygen, or have heart problems due to lung condition.I needed treatment for a sudden worsening of my condition within the last 6 weeks.I have a lung condition other than cystic fibrosis.I have been diagnosed with narrowed arteries in my kidneys.I am using birth control or am not of childbearing potential.Your blood pressure is lower than 90 mm Hg when you stand up.You have to cough up mucus every day.My lung condition has been stable, without treatment changes in the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: losartan
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What previous medical experiments have focused on Losartan as a treatment?
"At this time, there are 30 studies being conducted related to Losartan. Out of those investigations, two are currently in their third phase. Most of the trials for Losartan originate from San Francisco but it is available at 533 other locations as well."
Answered by AI
How many individuals have opted to partake in this research?
"Indeed, the clinicaltrials.gov page reveals that this trial is open for enrollment and actively seeking participants. This study was initially posted on February 15th 2022 with a recent update occurring on the same date. The research needs 16 subjects from one medical center to join in order to move forward."
Answered by AI
What health issues does Losartan address?
"Losartan is a successful therapeutic option for addressing diabetic nephropathy, proteinuria and left ventricular hypertrophy."
Answered by AI
Is enrollment currently available in this experiment?
"Affirmative. The clinical trial's data, initially posted on February 15th 2022 and recently updated on the same date, indicates that it is actively recruiting 16 patients at one site."
Answered by AI
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