NCT06996951 · Indiana University
Sinonasal Therapies and Histologic Correlations of Patients With Cystic Fibrosis in the Era of Highly Effective Modulator Therapy
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID
PATIENT WILL STOP USING NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID
DRUG
CONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID
PATIENT WILL CONTINUE USING NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 18 or older
- Cystic Fibrosis diagnosis on HEMT
- History of chronic rhinosinusitis
- Using topical nasal irrigations +/- additives (steroids, antibiotics)
Exclusion criteria
- 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
Where
- Indianapolis, Indiana
Collaborators
American Rhinologic Society
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 16, 2025 · Source of record for eligibility and locations