Cystic Fibrosis (CF)Phase 3NCT06996951
Sinonasal Therapies and Histologic Correlations of Patients With Cystic Fibrosis in the Era of Highly Effective Modulator Therapy
A Phase 3 study testing STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID and CONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID in people with Cystic Fibrosis (CF) and Chronic Rhinosinusitis (CRS), run by Indiana University at 1 site in United States.
Trial summary
The investigators are doing this study to discover if it is appropriate for people with Cystic Fibrosis (CF) on highly effective modulator therapy (HEMT) to stop using certain standard Sino nasal therapies such as high-volume nasal saline irrigations, topical nasal steroids, and topical nasal antibiotics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis (CF), Chronic Rhinosinusitis (CRS)
- What is being tested?
- STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID and CONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2025to Jul 2026
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Cystic Fibrosis diagnosis on HEMT
- History of chronic rhinosinusitis
- Using topical nasal irrigations +/- additives (steroids, antibiotics)
Who cannot join
- Below age of 18 years old
- Cystic Fibrosis patient NOT on highly effective modulator therapy
- Pregnant patients
- Not currently using topical nasal irrigations +/- additives (steroids, antibiotics)
- History of sinonasal or nasopharyngeal tumors
- Active sinonasal infection or pulmonary infection
- Admission to hospital for pulmonary exacerbation within last 3 months
- Oral antibiotics within last one month for upper respiratory or lower respiratory infection
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
Indiana University Health
Indianapolis, Indiana, 46202
Elisa A Illing, 317-944-6467, eilling@iu.edu
Azeezat A Yekinni, 317-529-6883, ayekinn@iu.edu
About this study
Official title: Sinonasal Therapies and Histologic Correlations for Patients With Cystic Fibrosis in the Era of Highly Effective Modulator Therapy
The investigators are doing this study to discover if it is appropriate for people with Cystic Fibrosis (CF) on highly effective modulator therapy (HEMT) to stop using certain standard Sino nasal therapies such as high-volume nasal saline irrigations, topical nasal steroids, and topical nasal antibiotics. They are also going to study the fluid inside the nose to see if there are changes when stopping these therapies. Right now, they are not sure if it is suggested to stop these treatments when patients begin highly effective modulator therapy (HEMT)
Read the detailed description
Cystic fibrosis (CF) is a widely known genetic disorder causing patients significant sinopulmonary disease. (1) The advent of highly effective modulator therapy (HEMT) has led to tremendous improvements in manifestations of disease in the lungs, sinuses, along with other organ systems, raising the question of whether and how to de-escalate other treatments for the airways. Specifically for CF, no protocols exist for the de-escalation of the most common sinonasal therapies: high-volume nasal saline irrigations, topical nasal steroids, and topical nasal antibiotics. Establishing such protocols would benefit patients by removing these cumbersome medication regimens, reducing the cost of medications, and lowering risks of side effects and complications from therapies that may no longer provide clinical benefit. This study aims to sample the sinonasal environment for inflammatory markers in patients with cystic fibrosis (PwCF )on HEMT and correlate to subjective and objective clinical findings during de-escalation trials from saline nasal irrigations, topical nasal steroids and/or antibiotics.
The investigators will prospectively follow adult cystic fibrosis patients with chronic rhinosinusitis with or without history of sinus surgery currently using CFTR modulator therapy via diagnostic methods (nasal endoscopy, FEV1, BMI) which are standard of care evaluations currently performed at both Rhinologic and Pulmonary visits. Questions regarding health care utilization (antibiotics, steroids, hospital admissions, doctor visits) will be reviewed, which are also part of the standard history taken at patient intake for these visits. Patient reported outcome measures (PROMS) (SNOT-22, Cystic Fibrosis Questionnaire- Revised (CFQ-R), Patient Health Questionnaire-9 (PHQ-9)) are also routinely collected at these Rhinologic and Pulmonary visits, thus patients are accustomed to these items in routine standard of care followups. Upon enrollment to the study after informed consent obtained, the patients will be randomly assigned to continue or stop topical medicated nasal irrigations. Participants will continue the 1-2 times per day they currently perform the saline topical nasal irrigations, or told to discontinue completely.
To better understand the inflammatory microenvironment on and off HEMT therapy, nasal leukosorb analyses will be studied from at 4-week intervals in the PwCF enrolled in aim 1 for the 12-week study period, to determine trends of inflammation for patients in each arm of the de-escalation study. Following protocols established by Rebuli et al, patients will moisten their nostrils with ~100uL of 0.9% sterile normal saline solution, followed by applying a cut sheet of Leukosorb medium of 4x40mm in length into each nostril onto the anterior part of the inferior turbinate. (19) The nostrils will then be clamped with a padded nose clip. The strips will be removed at 2 minutes, and placed into 1.5mL collection tubes and stored at -20 deg C until fluid elution and analysis.
- Conditions
- Cystic Fibrosis (CF), Chronic Rhinosinusitis (CRS)
- Being tested
- STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID, CONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROIDOther
PATIENT WILL STOP USING NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID
CONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROIDDrug
PATIENT WILL CONTINUE USING NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID
| Study group | Role | What they receive |
|---|---|---|
| CONTINUE TOPICAL STEROID NASAL IRRIGATION | Active comparator | PARTICIPANTS WILL CONTINUE THEIR NASAL TREATMENT WHICH WAS ALREADY PRESCRIBED BY THEIR PHYSICIAN Receives: Drug: CONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID |
| STOP TOPICAL NASAL TREATMENT | Experimental | PARTICIPANTS IN THIS ARM WILL BE ASKED TO STOP THEIR NASAL TREATMENT Receives: Other: STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lund Kennedy Score
Nasal Endoscopy will be performed in the clinic to evaluate the sinonasal cavities using the Lund Kennedy scoring system. The Lund-Kennedy endoscopic score grades the severity of chronic rhinosinusitis (CRS) based on findings from five areas: polyps, discharge, edema, scarring, and crusting, with each graded on a scale of 0 to 2 for each nostril, resulting in a total possible score of 20. A higher score indicates more severe disease.
Measured: Baseline, 12 weeks
Change in Pulmonary Function Testing
PULMONARY FUNCTION TESTING WILL BE PERFORMED WITH THE FEV1/FVC , CALCULATED. A lower score means poorer lung function.
Measured: Baseline, 12 weeks
Change in Body Mass Index (BMI)
BMI will be calculated as weight (kg) / height (m)2
Measured: Baseline, 12 weeks
Change in Health Care Utilization
Health Care Utilization will be measured though a grouped analysis for additional doctor visits, hospital admissions, and use of antibiotics and oral steroids.
Measured: Baseline, 12 weeks
Change in Sinonasal Outcome Test 22 Questionnaire (SNOT-22) Score
The SNOT-22 measures nasal symptoms and social/emotional consequences of rhinosinusitis, rated on a scale of 0 (no problem) to 5 (problem is as bad as it can be). Scores may range from 0 to 110, with higher scores indicating worse sinus symptoms
Measured: Baseline, 12 weeks
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score
The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a disease-specific health-related quality of life (HRQOL) measure for children, adolescents and adults with cystic fibrosis (CF). It is a profile measure of HRQOL with several different domains. The Cystic Fibrosis Questionnaire-Revised (CFQ-R) application calculates the score derived from the CFQ-R, on a 0-100 scale with higher scores indicating better HRQoL.
Measured: Baseline, 12 weeks
Change in Patient Health Questionnaire-9 (PHQ-9) Score
The PHQ-9 measures severity of depression. Potential scores may range from 0 - 27 with higher scores indicating more severe depression.
Measured: Baseline, 12 weeks
Secondary outcomes (1)
Change in nasal mucous biomarkers.
A small strip of Leukosorb paper will be placed in the nostril to collect nasal mucous. The strips will be tested for the present of inflammatory markers including IL-4, IL-6, IL-8, TNF-alpha, IL-1B, Neutrophil elastase levels. The presence of inflammatory markers may indicate the return of neutrophilic infiltration.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start2 Jul 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- More trials run by Indiana 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- American Rhinologic Society
- Responsible party
- Principal investigator, Elisa Illing, Indiana University
- Investigators
- Elisa Illing, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996951
- Sponsor's protocol ID
- 26204
- Status last verified
- Dec 2025
- First submitted
- 14 May 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sinonasal Therapies and Histologic Correlations for Patients With Cystic Fibrosis in the Era of Highly Effective Modulator Therapy
- ClinicalTrials.gov ID
- NCT06996951
- Acronym / sponsor ID
- 26204
- Conditions
- Cystic Fibrosis (CF), Chronic Rhinosinusitis (CRS)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- American Rhinologic Society
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 30 May 2025 (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 investigators are doing this study to discover if it is appropriate for people with Cystic Fibrosis (CF) on highly effective modulator therapy (HEMT) to stop using certain standard Sino nasal therapies such as high-volume nasal saline irrigations, topical nasal steroids, and topical nasal antibiotics. They are also going to study the fluid inside the nose to see if there are changes when stopping these therapies. Right now, they are not sure if it is suggested to stop these treatments when patients begin highly effective modulator therapy (HEMT)
Detailed description
Cystic fibrosis (CF) is a widely known genetic disorder causing patients significant sinopulmonary disease. (1) The advent of highly effective modulator therapy (HEMT) has led to tremendous improvements in manifestations of disease in the lungs, sinuses, along with other organ systems, raising the question of whether and how to de-escalate other treatments for the airways. Specifically for CF, no protocols exist for the de-escalation of the most common sinonasal therapies: high-volume nasal saline irrigations, topical nasal steroids, and topical nasal antibiotics. Establishing such protocols would benefit patients by removing these cumbersome medication regimens, reducing the cost of medications, and lowering risks of side effects and complications from therapies that may no longer provide clinical benefit. This study aims to sample the sinonasal environment for inflammatory markers in patients with cystic fibrosis (PwCF )on HEMT and correlate to subjective and objective clinical findings during de-escalation trials from saline nasal irrigations, topical nasal steroids and/or antibiotics.
The investigators will prospectively follow adult cystic fibrosis patients with chronic rhinosinusitis with or without history of sinus surgery currently using CFTR modulator therapy via diagnostic methods (nasal endoscopy, FEV1, BMI) which are standard of care evaluations currently performed at both Rhinologic and Pulmonary visits. Questions regarding health care utilization (antibiotics, steroids, hospital admissions, doctor visits) will be reviewed, which are also part of the standard history taken at patient intake for these visits. Patient reported outcome measures (PROMS) (SNOT-22, Cystic Fibrosis Questionnaire- Revised (CFQ-R), Patient Health Questionnaire-9 (PHQ-9)) are also routinely collected at these Rhinologic and Pulmonary visits, thus patients are accustomed to these items in routine standard of care followups. Upon enrollment to the study after informed consent obtained, the patients will be randomly assigned to continue or stop topical medicated nasal irrigations. Participants will continue the 1-2 times per day they currently perform the saline topical nasal irrigations, or told to discontinue completely.
To better understand the inflammatory microenvironment on and off HEMT therapy, nasal leukosorb analyses will be studied from at 4-week intervals in the PwCF enrolled in aim 1 for the 12-week study period, to determine trends of inflammation for patients in each arm of the de-escalation study. Following protocols established by Rebuli et al, patients will moisten their nostrils with ~100uL of 0.9% sterile normal saline solution, followed by applying a cut sheet of Leukosorb medium of 4x40mm in length into each nostril onto the anterior part of the inferior turbinate. (19) The nostrils will then be clamped with a padded nose clip. The strips will be removed at 2 minutes, and placed into 1.5mL collection tubes and stored at -20 deg C until fluid elution and analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTINUE TOPICAL STEROID NASAL IRRIGATION | Active comparator | Drug: CONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROIDPARTICIPANTS WILL CONTINUE THEIR NASAL TREATMENT WHICH WAS ALREADY PRESCRIBED BY THEIR PHYSICIAN |
| STOP TOPICAL NASAL TREATMENT | Experimental | Other: STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROIDPARTICIPANTS IN THIS ARM WILL BE ASKED TO STOP THEIR NASAL TREATMENT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older
- Cystic Fibrosis diagnosis on HEMT
- History of chronic rhinosinusitis
- Using topical nasal irrigations +/- additives (steroids, antibiotics)
Key exclusion criteria (8 listed)
- Below age of 18 years old
- Cystic Fibrosis patient NOT on highly effective modulator therapy
- Pregnant patients
- Not currently using topical nasal irrigations +/- additives (steroids, antibiotics)
- History of sinonasal or nasopharyngeal tumors
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 |
|---|---|---|
| STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROIDPATIENT WILL STOP USING NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID | Other | STOP TOPICAL NASAL TREATMENT |
| CONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROIDPATIENT WILL CONTINUE USING NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID | Drug | CONTINUE TOPICAL STEROID NASAL IRRIGATION |
Primary outcome
Change in Lund Kennedy Score
Time frame: Baseline, 12 weeks
Nasal Endoscopy will be performed in the clinic to evaluate the sinonasal cavities using the Lund Kennedy scoring system. The Lund-Kennedy endoscopic score grades the severity of chronic rhinosinusitis (CRS) based on findings from five areas: polyps, discharge, edema, scarring, and crusting, with each graded on a scale of 0 to 2 for each nostril, resulting in a total possible score of 20. A higher score indicates more severe disease.
Change in Pulmonary Function Testing
Time frame: Baseline, 12 weeks
PULMONARY FUNCTION TESTING WILL BE PERFORMED WITH THE FEV1/FVC , CALCULATED. A lower score means poorer lung function.
Change in Body Mass Index (BMI)
Time frame: Baseline, 12 weeks
BMI will be calculated as weight (kg) / height (m)2
Change in Health Care Utilization
Time frame: Baseline, 12 weeks
Health Care Utilization will be measured though a grouped analysis for additional doctor visits, hospital admissions, and use of antibiotics and oral steroids.
Change in Sinonasal Outcome Test 22 Questionnaire (SNOT-22) Score
Time frame: Baseline, 12 weeks
The SNOT-22 measures nasal symptoms and social/emotional consequences of rhinosinusitis, rated on a scale of 0 (no problem) to 5 (problem is as bad as it can be). Scores may range from 0 to 110, with higher scores indicating worse sinus symptoms
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score
Time frame: Baseline, 12 weeks
The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a disease-specific health-related quality of life (HRQOL) measure for children, adolescents and adults with cystic fibrosis (CF). It is a profile measure of HRQOL with several different domains. The Cystic Fibrosis Questionnaire-Revised (CFQ-R) application calculates the score derived from the CFQ-R, on a 0-100 scale with higher scores indicating better HRQoL.
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: Baseline, 12 weeks
The PHQ-9 measures severity of depression. Potential scores may range from 0 - 27 with higher scores indicating more severe depression.
1 secondary outcome
Change in nasal mucous biomarkers.
Time frame: Baseline, 12 weeks
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 16 Dec 2025.
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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.
Elisa Illing, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID and CONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID in people with Cystic Fibrosis (CF) and Chronic Rhinosinusitis (CRS), run by Indiana University 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 8 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 16 Dec 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Elisa Illing, MD (317-944-6467, eilling@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lund Kennedy Score (time frame: Baseline, 12 weeks). The study lists 7 primary outcomes in all. 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 Dec 2025.