Cystic FibrosisPhase 2NCT06364176
Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis.
A Phase 2 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 clinical trial is to test use of losartan in those with cystic fibrosis (CF) on modulator therapy. The main question it aims to answer is if treatment with losartan improves response of the CF transmembrane conductance regulator (CFTR) channel to modulator therapy. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Losartan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2024to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Established diagnosis of cystic fibrosis
- Age 12 years and older
- Stable use of elexacaftor/tezacaftor/ivacaftor for 90 days prior to enrollment
- Sweat chloride concentration 50 mmol/L or greater while on elexacaftor/tezacaftor/ivacaftor
Who cannot join
- Prior lung transplant
- BMI <18
- CF pulmonary exacerbation requiring hospitalization or intravenous antibiotics in the preceding 30 days
- Systemic corticosteroid or regular non-steroidal anti-inflammatory use in the preceding 30 days
- Chronic use of angiotensin receptor blockers or angiotensin converting enzyme inhibitors
- Concomitant use of medications known to interact with losartan, including aliskiren
Show all 11Show fewer
- Chronic renal insufficiency (creatinine clearance <45 ml/min)
- Pregnancy or lactation
- Inability or unwillingness to comply with approved contraceptive method during the study period (females of childbearing age)
- In the opinion of the investigator any severe or acute or chronic condition or laboratory abnormality that may increase the risk associated with trial participation or make the participant inappropriate for enrollment
- Participation in another interventional trial that, in the opinion of the investigator, has the potential to affect the primary outcome
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Charles Bengtson, MD, MSc, 913-588-6000
Carolina Aguiar, 9139459295
About this study
Official title: Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis
The goal of this clinical trial is to test use of losartan in those with cystic fibrosis (CF) on modulator therapy. The main question it aims to answer is if treatment with losartan improves response of the CF transmembrane conductance regulator (CFTR) channel to modulator therapy.
Participants will be asked take losartan or placebo for twelve weeks and will have changes in sweat chloride levels measured as a marker of CFTR function.
Read the detailed description
This is a randomized, placebo-controlled, parallel group clinical trial in those those with CF on elexacaftor/tezacaftor/ivacaftor to determine if treatment with losartan improves response to modulator therapy using sweat chloride as an marker of CFTR function.
- Conditions
- Cystic Fibrosis
- Being tested
- Losartan, Placebo
- Keywords
- 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
Treatment with losartan through week 12
PlaceboDrug
Treatment with placebo through week 12
| Study group | Role | What they receive |
|---|---|---|
| Losartan | Experimental | Losartan 25mg twice daily for one week followed by 50mg twice daily through week 12. Receives: Drug: Losartan |
| Placebo | Placebo comparator | Placebo twice daily through week 12 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sweat chloride
Change in sweat chloride concentration
Measured: Baseline through week 12
Secondary outcomes (8)
Lung function - absolute
Absolute change in percent predicted forced expiratory volume in one second (ppFEV1)
Measured: Baseline through week 12
Lung function - relative
Relative change in ppFEV1
Measured: Baseline through week 12
Transforming growth factor (TGF)-beta1 - airway
Change in nasal fluid levels of TGF-beta1
Measured: Baseline through week 12
TGF-beta1 - systemic
Change in plasma levels of TGF-beta1
Measured: Baseline through week 12
Inflammatory mediators - airway
Change in concentration nasal fluid levels of inflammatory mediators (interleukin-1beta, interleukin-8, tumor necrosis factor-alpha)
Measured: Baseline through week 12
Inflammatory mediators - systemic
Change in plasma levels of inflammatory mediators (interleukin-1beta, interleukin-8, tumor necrosis factor-alpha)
Measured: Baseline through week 12
CFQ-R
Change in CF questionnaire revised (CFQ-R); scale 0-100 with higher scores indicating better quality of life
Measured: Baseline through week 12
Adverse events
Cumulative incidence of adverse events
Measured: Baseline through week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start3 Jun 2024
- Primary completionMay 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Bengtson, MD, MSc, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364176
- Sponsor's protocol ID
- STUDY00149479
- Status last verified
- Apr 2025
- First submitted
- 6 Mar 2024
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT06364176
- Acronym / sponsor ID
- STUDY00149479
- Conditions
- Cystic Fibrosis
- Keywords
- losartan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 15 Apr 2024 (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 clinical trial is to test use of losartan in those with cystic fibrosis (CF) on modulator therapy. The main question it aims to answer is if treatment with losartan improves response of the CF transmembrane conductance regulator (CFTR) channel to modulator therapy.
Participants will be asked take losartan or placebo for twelve weeks and will have changes in sweat chloride levels measured as a marker of CFTR function.
Detailed description
This is a randomized, placebo-controlled, parallel group clinical trial in those those with CF on elexacaftor/tezacaftor/ivacaftor to determine if treatment with losartan improves response to modulator therapy using sweat chloride as an marker of CFTR function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Losartan | Experimental | Drug: LosartanLosartan 25mg twice daily for one week followed by 50mg twice daily through week 12. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo twice daily through week 12 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Established diagnosis of cystic fibrosis
- Age 12 years and older
- Stable use of elexacaftor/tezacaftor/ivacaftor for 90 days prior to enrollment
- Sweat chloride concentration 50 mmol/L or greater while on elexacaftor/tezacaftor/ivacaftor
Key exclusion criteria (11 listed)
- Prior lung transplant
- BMI <18
- CF pulmonary exacerbation requiring hospitalization or intravenous antibiotics in the preceding 30 days
- Systemic corticosteroid or regular non-steroidal anti-inflammatory use in the preceding 30 days
- Chronic use of angiotensin receptor blockers or angiotensin converting enzyme inhibitors
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 |
|---|---|---|
| LosartanTreatment with losartan through week 12 | Drug | Losartan |
| PlaceboTreatment with placebo through week 12 | Drug | Placebo |
Primary outcome
Sweat chloride
Time frame: Baseline through week 12
Change in sweat chloride concentration
8 secondary outcomes
Lung function - absolute
Time frame: Baseline through week 12
Lung function - relative
Time frame: Baseline through week 12
Transforming growth factor (TGF)-beta1 - airway
Time frame: Baseline through week 12
TGF-beta1 - systemic
Time frame: Baseline through week 12
Inflammatory mediators - airway
Time frame: Baseline through week 12
Inflammatory mediators - systemic
Time frame: Baseline through week 12
CFQ-R
Time frame: Baseline through week 12
Adverse events
Time frame: Baseline through week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: Yes
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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.
Charles Bengtson, MD, MSc principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 2 May 2025. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heidi Hellwig (9135886045, hhellwig@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sweat chloride (time frame: Baseline through week 12). 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 2 May 2025.