Sinonasal Therapies and Histologic Correlations of Patients With Cystic Fibrosis in the Era of Highly Effective Modulator Therapy

Conditions

• Chronic Rhinosinusitis (CRS)
• Cystic Fibrosis (CF)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID — OTHER
  PATIENT WILL STOP USING NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID
• CONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID — DRUG
  PATIENT WILL CONTINUE USING NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

Study Details

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)

Key Dates

Start date

Jul 2, 2025

Status verified

Dec 2025

Primary completion

Jul 31, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

64 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: CONTINUE TOPICAL STEROID NASAL IRRIGATION
  PARTICIPANTS WILL CONTINUE THEIR NASAL TREATMENT WHICH WAS ALREADY PRESCRIBED BY THEIR PHYSICIAN
• Experimental: STOP TOPICAL NASAL TREATMENT
  PARTICIPANTS IN THIS ARM WILL BE ASKED TO STOP THEIR NASAL TREATMENT

Primary Outcome Measure

Change in Lund Kennedy Score [ Time Frame: Baseline, 12 weeks ]

Central Contacts

• Elisa Illing, MD
  317-944-6467
  [email protected]

Locations (1)

Find similar trials in Indianapolis, IN

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