Recruiting
Phase 3

HEMT

Sponsor:

Indiana University

Code:

NCT06996951

Conditions

Cystic Fibrosis (CF)

Chronic Rhinosinusitis (CRS)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

CONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

Study Details

Brief 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)

Conditions

Cystic Fibrosis (CF)

Chronic Rhinosinusitis (CRS)

Study ID

NCT06996951

Start date

Jul 2, 2025

Status verified date

Dec, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

PATIENT WILL STOP USING NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

CONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

PATIENT WILL CONTINUE USING NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

Primary outcome measure

  • Change in Lund Kennedy Score [ Time Frame: Baseline, 12 weeks ]
  • Change in Pulmonary Function Testing [ Time Frame: Baseline, 12 weeks ]
  • Change in Body Mass Index (BMI) [ Time Frame: Baseline, 12 weeks ]
  • Change in Health Care Utilization [ Time Frame: Baseline, 12 weeks ]
  • Change in Sinonasal Outcome Test 22 Questionnaire (SNOT-22) Score [ Time Frame: Baseline, 12 weeks ]
  • Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score [ Time Frame: Baseline, 12 weeks ]
  • Change in Patient Health Questionnaire-9 (PHQ-9) Score [ Time Frame: Baseline, 12 weeks ]

Central Contacts and Locations

Central contacts

Elisa Illing, MD

317-944-6467eilling@iu.edu

Locations

Indiana University Health

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Elisa A Illing

317-944-6467eilling@iu.edu

Azeezat A Yekinni

317-529-6883ayekinn@iu.edu

Principal Investigator:

Elisa A Illing

More Information

Sponsor

Indiana University

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Indiana University on 2025-12-16.