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NCT06996951 · ClinicalTrials.gov registry record · Phase 3
Sinonasal Therapies and Histologic Correlations of Patients With Cystic Fibrosis in the Era of Highly Effective Modulator Therapy
A Phase 3 study of Cystic Fibrosis (CF) and Chronic Rhinosinusitis (CRS), sponsored by Indiana University.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT06996951: Recruiting Phase 3 study of Cystic Fibrosis (CF) and Chronic Rhinosinusitis (CRS), sponsored by Indiana University.
NCT06996951 is a Phase 3 study of Cystic Fibrosis (CF) and Chronic Rhinosinusitis (CRS) that is actively recruiting participants, run by Indiana University. The registered enrollment target is 64 participants, below the 136-participant average among 14 other Cystic Fibrosis (CF) trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06996951, a Phase 3 study of Cystic Fibrosis (CF) and Chronic Rhinosinusitis (CRS), is actively recruiting participants, sponsored by Indiana University.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 64 participants
- Enrollment target
- 1
- Study location
Study 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. 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)
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID
- DRUG CONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID
Study Locations (1)
Indiana
- Indiana University Health - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2025-07-02 |
| Est. Completion | 2026-07 |
| Phase | Phase 3 |
What NCT06996951 shows while recruiting
NCT06996951 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 136-participant average among 14 other Cystic Fibrosis (CF) trials with a reported enrollment target (53% lower).
The record links to 2 conditions, with Cystic Fibrosis (CF) appearing as the primary indexed condition, and to 2 interventions - of which STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID is the first listed.
NCT06996951 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT06996951 about?
NCT06996951 is a clinical study titled "Sinonasal Therapies and Histologic Correlations of 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 antibi...
What is the current status of trial NCT06996951?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 64 participants. The study started on 2025-07-02. Estimated completion is 2026-07.
What conditions does trial NCT06996951 study?
This clinical trial studies the following conditions: Cystic Fibrosis (CF), Chronic Rhinosinusitis (CRS).
What interventions are being tested in trial NCT06996951?
The interventions under investigation include: STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID (OTHER), CONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID (DRUG).
Who is sponsoring clinical trial NCT06996951?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06996951 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis (CF)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06996951's enrollment target sits among peer trials
64 9th of 14 higher than 6 of 14 other Cystic Fibrosis (CF) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis (CF) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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