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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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)

Who May Be Eligible (Plain English)

Who May Qualify: - Age 18 or older - Cystic Fibrosis diagnosis on HEMT - History of chronic rhinosinusitis - Using topical nasal irrigations +/- additives (steroids, antibiotics) Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

PATIENT WILL STOP USING NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

DRUG

CONTINUE 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