Stopping or continuing nasal rinses and topical nasal medicines for adults with cystic fibrosis on modulator therapy
Sinonasal Therapies and Histologic Correlations for Patients With Cystic Fibrosis in the Era of Highly Effective Modulator Therapy
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 |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT06996951 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Indianapolis, Indiana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.