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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University

About this trial

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 criteria

Qualifiers

Age 18 or older

Cystic Fibrosis diagnosis on HEMT

History of chronic rhinosinusitis

Using topical nasal irrigations +/- additives (steroids, antibiotics)

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID
  • CONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

Treatment groups

64 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Indiana University

Lead sponsor

American Rhinologic Society

Collaborator