RecruitingPhase 3NCT06996951

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

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


Sponsor

Indiana University

Enrollment

64 participants

Start Date

Jul 2, 2025

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Age 18 or older
  • Cystic Fibrosis diagnosis on HEMT
  • History of chronic rhinosinusitis
  • Using topical nasal irrigations +/- additives (steroids, antibiotics)

Exclusion Criteria8

  • 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

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Interventions

OTHERSTOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

PATIENT WILL STOP USING NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

DRUGCONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

PATIENT WILL CONTINUE USING NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID


Locations(1)

Indiana University Health

Indianapolis, Indiana, United States

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NCT06996951


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