Stopping or continuing nasal rinses and topical nasal medicines for adults with cystic fibrosis on modulator therapy
Official title: Sinonasal Therapies and Histologic Correlations for Patients With Cystic Fibrosis in the Era of Highly Effective Modulator Therapy
Run by Indiana University · NCT06996951 · Data updated 2026-11-12
This project will see if adults with cystic fibrosis who are taking highly effective modulator therapy can safely stop nasal rinses and topical nasal steroid or antibiotic treatments without making sinus inflammation worse.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 64 (estimated) |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Status | Recruiting |
| Started | July 2, 2025 |
| Main results expected | July 2027 |
| Study ends | July 2027 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT06996951 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥18 years) with cystic fibrosis on highly effective modulator therapy who have chronic rhinosinusitis and are currently using high-volume nasal saline irrigations with or without topical steroid or antibiotic additives.
✕Probably not a fit
Patients not on highly effective modulators, those with active sinonasal or recent pulmonary infection, recent oral antibiotics, pregnancy, sinonasal tumors, or who are not currently using nasal irrigations are unlikely to benefit from this de‑escalation protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with cystic fibrosis on highly effective modulator therapy who have chronic rhinosinusitis and currently use nasal irrigations will be followed prospectively. Participants will be assigned to either stop nasal saline irrigations with or without topical steroid/antibiotic additives or to continue their usual regimen. Investigators will collect nasal fluid for inflammatory markers, perform nasal endoscopy, record pulmonary function (FEV1) and BMI, and track healthcare use and infections over time. The study will correlate biologic changes in the sinonasal environment with symptoms and objective findings during the de‑escalation period.
Why it matters
Potential benefit: If successful, patients may be able to reduce or stop cumbersome nasal treatments, lowering cost, side effects, and daily treatment burden.
How similar studies have gone: HEMT has been shown to improve sinonasal disease in CF, but formal clinical trials specifically testing de‑escalation of nasal therapies are limited, so this approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 it's running
-
Indiana University Health
Indianapolis, Indiana, United States Recruiting
Study contacts
- Principal investigator: Elisa Illing, MD — Indiana University
- Study coordinator: Elisa Illing, MD
- Email: eilling@iu.edu
- Phone: 317-944-6467
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.