Cystic FibrosisEarly Phase 1NCT03435939
Effect of Losartan in Cystic Fibrosis (CF)-NIH Grant #133240
A Early Phase 1 study testing Losartan in people with Cystic Fibrosis, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The goal of this study is to execute a small clinical proof of concept trial: To examine the effects of losartan on mucociliary clearance (MCC) in patients not eligible for CFTR rescue therapies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Losartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2022to 31 Mar 2026
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CF patients with any known mutation combination not on CFTR augmentation therapy
- ≥18 years of age
- Severity of the Disease: Suitable patients will have mild to moderate lung disease, as defined by:
- Pulmonary Function: Each patient must have an FEV1 ≥40% of predicted at the screening visit.
- Hemoglobin saturation: Patients must have an oxygen saturation of >92% on room air as determined by pulse oximetry at the screening visit.
- Produces sputum regularly (daily basis, at minimum)
Show all 9Show fewer
- FEV1 ≥ 40% of predicted at screening visit
- Able to sign Informed consent
- Negative COVID-19 test within 72 hours prior to MCC testing
Who cannot join
- When enrolling female patients
- Not willing to adhere to strict birth control (combination of two methods)
- If female, patient must be non-pregnant and non-lactating, and those of childbearing potential must be using an acceptable method of birth control (i.e., an Intrauterine Contraceptive Device with a failure rate of <1%, hormonal contraceptives or a barrier method). If a female patient is abstinent, she must agree to use one of the acceptable methods if she becomes sexually active.
- Unstable lung disease: As defined by a change in medical regimen during the preceding 2 weeks or an FEV1 ≥15% below value within 3 months
- Received an investigational drug or therapy during the preceding 30 days
- Active or former smokers with less than 1 year since quitting, or >10 pack-year smoking history
Show all 23Show fewer
- Unable to adequately complete study measures, including spirometry
- Intolerance to angiotensin receptor blockers (ARB)
- Treatment with angiotensin converting enzyme (ACE) inhibitor
- Regular use of NSAIDs or potassium supplementation, treatment with aliskiren, on anticoagulation
- Oral corticosteroid use within 6 weeks
- Exacerbation requiring treatment within 6 weeks
- Treatment of mycobacterial infections
- Significant hypoxemia (oxygen saturation <92% on room air and rest or use of continuous oxygen treatment), chronic respiratory failure by history (pCO2 > 45 mmHg), clinical evidence of cor pulmonale
- Untreated arterial hypertension (systolic blood pressure >140 mm Hg, diastolic blood pressure > 90 mmHg)
- Blood pressure less than 90 mm Hg systolic while standing
- Cardiac, renal (creatinine 1.5 times normal limit), hepatic (LFTs > 3x normal upper limit), neurological, psychiatric, endocrine or neoplastic diseases that are judged to interfere with participation in study
- Known renal artery stenosis
- Concomitant airway disorders other than CF, such as ABPA
- Subjects with prior thoracic surgery
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the PI, would make the subject inappropriate for enrollment.
- Patients using intermittent inhaled or oral antibiotics will be allowed to participate in this trial. Patients on chronic, cycling antibiotics will be required to have completed at least 2 full cycles of the prescribed antibiotic prior to enrollment and should be studied during the same phase of treatment (on or off) during each study period.
- Have had radiation exposure within the past year that would cause them to exceed Federal Regulations by participating in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Anti-Inflammatory Therapy to Augment CFTR Rescue in CF Patients
The goal of this study is to execute a small clinical proof of concept trial: To examine the effects of losartan on mucociliary clearance (MCC) in patients not eligible for CFTR rescue therapies
Read the detailed description
CF is the most common inherited disease causing a shortened life span, affecting ~30,000 people in the United States with annual health care costs of at least $1.8 billion. The median age of predicted survival of these patients has improved and is now almost 40 years in the US. Over the last two decades, investigators have identified ~2,000 mutations in the CF transmembrane conductance regulator (CFTR) gene. These mutations are imperfectly classified into 5 groups, and small molecules are being developed that rescue group-specific CFTR mutants. These agents have produced remarkable improvements in some patients. The CFTR potentiator ivacaftor (Kalydeco™), approved by the FDA mainly for class III mutations especially G551D, improves ion transport (large decrease in sweat chloride), clinical outcome (increased FEV1 and weight, decreased exacerbations), and quality of life. Furthermore, the FDA recently approved Orkambi™ (a corrector and potentiator: lumacaftor plus ivacaftor) because it reduced exacerbation rates by up to 39% in patients homozygous for F508del.
It has been demonstrated in vitro that improvements in airway surface liquid (ASL) volume are highly predictive of changes seen in clinical studies and track with tracheal mucus velocities measured in sheep in vivo using the CFTR potentiator ivacaftor, inhaled hypertonic saline and other interventions (preliminary data). ASL volume is regulated by ion fluxes through ENaC, CFTR, CaCC, and BK channels, and TGF-β1-mediated inflammation in CF cells decreases activities of CaCC (8) and BK. These findings suggest that effective and safe anti-inflammatory therapy has the potential to improve mucociliary dysfunction in CF patients, even in the absence of small molecule therapy. Currently used anti-inflammatory therapies such as high-dose ibuprofen and steroids produce unwanted side effects that negate their effectiveness. Other medications showed severe side effects in clinical trials. However, experiments proposed in this application will test the hypothesis that losartan provides a safe and effective anti-inflammatory therapy needed to improve outcomes in CF patients.
Briefly, 16 patients with CF, >18 years of age, who are not on CFTR augmentation therapy will be recruited for this trial (4 per year). After signing informed consent at the screening visit, spirometry will be performed, take blood for safety and inflammatory markers, and test for pregnancy where applicable. Since losartan has teratogenic effects, strict birth control in female participants will be enforced. Eligible patients will complete visits as following:
Quality of life will be assessed by CF quality of life questionnaire - revised (CFQ-R). Cytokines will be measured from nasal fluid collected by Leukosorb filter paper. After assessing baselines, a daily dose of 50 mg losartan will be started, followed by a safety visit 7 days after treatment start (± 2 days). Then, the losartan dose will be increased to 100 mg daily until week 14. Since this trial assesses anti-inflammatory effects of 100 mg losartan, the total duration will be 14 weeks to achieve >12 weeks of treatment with losartan.
- Conditions
- Cystic Fibrosis
- Being tested
- Losartan
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Also called Cozaar
50 mg/day for 7 days followed by 100 mg/day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| losartan | Experimental | 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. Receives: Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of mucociliary clearance ( MCC) and cough clearance (CC)
Losartan (100 mg for >12 weeks) will improve MCC+CC clearance in CF patients not on CFTR augmentation therapy in % of baseline
Measured: 12 weeks treatment
Secondary outcomes (4)
Improvement on pulmonary function tests (in %predicted)
forced expiratory volume at one second (FEV1) in %predicted
Measured: 12 weeks of treatment
Improvement on pulmonary function tests (in L)
forced expiratory volume at one second (FEV1) in liters
Measured: 12 weeks of treatment
Decrease of inflammatory markers
Changes in serum inflammatory markers (hsCRP, WBC including absolute neutrophil count, %PMNs, serum amyloid A or SAA, calprotectin, GM-CSF, TGF-β active and total)
Measured: 12 weeks
Nasal cytokine changes
Nasal cytokine changes (TGF-β1 active and total, TNF-α, IL-1β, IL-6, IL-8, IL-13, COX-2)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start15 Feb 2022
- Primary completion3 Sep 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Salathe, MD, University of Kansas Medical Center
- Investigators
- Matthias Salathe, MD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435939
- Sponsor's protocol ID
- STUDY00146945
- Status last verified
- Oct 2025
- First submitted
- 5 Feb 2018
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: since this study is a pilot study, participant data will not be shared to other researchers.
Publications
Bengtson CD, Schmid A, Kim MD, Dennis JS, Leeder JS, Zeman KL, Bennett WD, Sabater J, Baumlin N, Salathe M. Oral losartan yields subtherapeutic airway exposure compared to nebulized delivery and fails to improve mucociliary clearance in cystic fibrosis. Front Pharmacol. 2026 May 4;17:1807581. doi: 10.3389/fphar.2026.1807581. eCollection 2026.
PubMed 42158940
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Inflammatory Therapy to Augment CFTR Rescue in CF Patients
- ClinicalTrials.gov ID
- NCT03435939
- Acronym / sponsor ID
- STUDY00146945
- Conditions
- Cystic Fibrosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 19 Feb 2018 (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.
The goal of this study is to execute a small clinical proof of concept trial: To examine the effects of losartan on mucociliary clearance (MCC) in patients not eligible for CFTR rescue therapies
Detailed description
CF is the most common inherited disease causing a shortened life span, affecting ~30,000 people in the United States with annual health care costs of at least $1.8 billion. The median age of predicted survival of these patients has improved and is now almost 40 years in the US. Over the last two decades, investigators have identified ~2,000 mutations in the CF transmembrane conductance regulator (CFTR) gene. These mutations are imperfectly classified into 5 groups, and small molecules are being developed that rescue group-specific CFTR mutants. These agents have produced remarkable improvements in some patients. The CFTR potentiator ivacaftor (Kalydeco™), approved by the FDA mainly for class III mutations especially G551D, improves ion transport (large decrease in sweat chloride), clinical outcome (increased FEV1 and weight, decreased exacerbations), and quality of life. Furthermore, the FDA recently approved Orkambi™ (a corrector and potentiator: lumacaftor plus ivacaftor) because it reduced exacerbation rates by up to 39% in patients homozygous for F508del.
It has been demonstrated in vitro that improvements in airway surface liquid (ASL) volume are highly predictive of changes seen in clinical studies and track with tracheal mucus velocities measured in sheep in vivo using the CFTR potentiator ivacaftor, inhaled hypertonic saline and other interventions (preliminary data). ASL volume is regulated by ion fluxes through ENaC, CFTR, CaCC, and BK channels, and TGF-β1-mediated inflammation in CF cells decreases activities of CaCC (8) and BK. These findings suggest that effective and safe anti-inflammatory therapy has the potential to improve mucociliary dysfunction in CF patients, even in the absence of small molecule therapy. Currently used anti-inflammatory therapies such as high-dose ibuprofen and steroids produce unwanted side effects that negate their effectiveness. Other medications showed severe side effects in clinical trials. However, experiments proposed in this application will test the hypothesis that losartan provides a safe and effective anti-inflammatory therapy needed to improve outcomes in CF patients.
Briefly, 16 patients with CF, >18 years of age, who are not on CFTR augmentation therapy will be recruited for this trial (4 per year). After signing informed consent at the screening visit, spirometry will be performed, take blood for safety and inflammatory markers, and test for pregnancy where applicable. Since losartan has teratogenic effects, strict birth control in female participants will be enforced. Eligible patients will complete visits as following:
Quality of life will be assessed by CF quality of life questionnaire - revised (CFQ-R). Cytokines will be measured from nasal fluid collected by Leukosorb filter paper. After assessing baselines, a daily dose of 50 mg losartan will be started, followed by a safety visit 7 days after treatment start (± 2 days). Then, the losartan dose will be increased to 100 mg daily until week 14. Since this trial assesses anti-inflammatory effects of 100 mg losartan, the total duration will be 14 weeks to achieve >12 weeks of treatment with losartan.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| losartan | Experimental | Drug: Losartana 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- CF patients with any known mutation combination not on CFTR augmentation therapy
- ≥18 years of age
- Severity of the Disease: Suitable patients will have mild to moderate lung disease, as defined by:
- FEV1 ≥ 40% of predicted at screening visit
- Able to sign Informed consent
Key exclusion criteria (23 listed)
- When enrolling female patients
- Not willing to adhere to strict birth control (combination of two methods)
- If female, patient must be non-pregnant and non-lactating, and those of childbearing potential must be using an acceptable method of birth control (i.e., an Intrauterine Contraceptive Device with a failure rate of <1%, hormonal contraceptives or a barrier method). If a female patient is abstinent, she must agree to use one of the acceptable methods if she becomes sexually active.
- Unstable lung disease: As defined by a change in medical regimen during the preceding 2 weeks or an FEV1 ≥15% below value within 3 months
- Received an investigational drug or therapy during the preceding 30 days
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 |
|---|---|---|
| LosartanAlso: Cozaar50 mg/day for 7 days followed by 100 mg/day for 12 weeks | Drug | losartan |
Primary outcome
Improvement of mucociliary clearance ( MCC) and cough clearance (CC)
Time frame: 12 weeks treatment
Losartan (100 mg for >12 weeks) will improve MCC+CC clearance in CF patients not on CFTR augmentation therapy in % of baseline
4 secondary outcomes
Improvement on pulmonary function tests (in %predicted)
Time frame: 12 weeks of treatment
Improvement on pulmonary function tests (in L)
Time frame: 12 weeks of treatment
Decrease of inflammatory markers
Time frame: 12 weeks
Nasal cytokine changes
Time frame: 12 weeks
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 1 May 2026.
- Derived from this study: PubMed 42158940Bengtson CD, Schmid A, Kim MD, Dennis JS, Leeder JS, Zeman KL, Bennett WD, Sabater J, Baumlin N, Salathe M. Oral losartan yields subtherapeutic airway exposure compared to nebulized delivery and fails to improve mucociliary clearance in cystic fibrosis. Front Pharmacol. 2026 May 4;17:1807581. doi: 10.3389/fphar.2026.1807581. eCollection 2026.
- Individual participant dataSharing planned: No. since this study is a pilot study, participant data will not be shared to other researchers.
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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.
Matthias Salathe, MD principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Losartan in people with Cystic Fibrosis, run by University of Kansas Medical Center at 1 site in United States.
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 9 inclusion and 23 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 1 May 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Improvement of mucociliary clearance ( MCC) and cough clearance (CC) (time frame: 12 weeks treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03435939, which also lists 1 linked publication.
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 1 May 2026.