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

RecruitingPhase 3Ages 18 Years - anyAllIndiana University
NCT06996951 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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)

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📋 Eligibility rules (as published)
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
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What it tests

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

1 site
Indiana University Health
Indianapolis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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