Sinonasal Therapies for Cystic Fibrosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if people with Cystic Fibrosis (CF) on highly effective modulator therapy (HEMT) can safely discontinue certain nasal treatments, such as saline rinses and nasal steroids. Researchers seek to understand how stopping these treatments affects nasal fluid. Participants will either cease their nasal treatment or continue it as usual. This study targets adults with CF who are on HEMT and have been regularly using nasal treatments. As a Phase 3 trial, it represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications for this trial?
The trial is studying whether people with Cystic Fibrosis on highly effective modulator therapy should stop using certain nasal treatments like saline irrigations, nasal steroids, and antibiotics. It doesn't specify if you must stop other medications, so it's best to ask the trial team for guidance.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that stopping nasal saline rinses, with or without added steroids, is generally safe. Studies have found that nasal saline rinses can help clear mucus and improve nasal symptoms for people with cystic fibrosis. Regular saline use improved nasal symptoms in 35% of cases and enhanced quality of life in 30% of cases. Using steroids in nasal rinses proved more effective than steroid sprays for symptom improvement. The trial is in a late phase, indicating that safety has been thoroughly studied. While stopping these treatments should not cause major problems, discussing any concerns with a healthcare provider is always important.12345
Why are researchers excited about this trial's treatment?
Researchers are excited about this trial because it explores the effects of stopping nasal saline irrigation in cystic fibrosis patients, with or without continuing steroid use. Current treatments for cystic fibrosis often include regular nasal irrigation and steroid nasal sprays to manage symptoms. This trial aims to understand whether halting nasal irrigation impacts symptom management and overall patient well-being. By investigating this, researchers hope to find out if patients can maintain their quality of life with potentially fewer treatment burdens. This could lead to more personalized and efficient treatment plans for those with cystic fibrosis.
What evidence suggests that stopping nasal saline irrigation with or without steroid might be an effective treatment for Cystic Fibrosis?
Research has shown that rinsing the nose with saltwater can help people with cystic fibrosis (CF) by clearing thick mucus and improving nasal health. Studies have found that saltwater rinses can lead to better healing and fewer symptoms like crusting and swelling in the nose. However, whether people on highly effective modulator therapy (HEMT) still need these treatments remains uncertain. Some evidence suggests that CFTR modulators, part of HEMT, might reduce the need for additional treatments. This trial will compare two approaches: one group of participants will stop their nasal treatment, while another group will continue their prescribed nasal steroid irrigation. The goal is to determine if stopping nasal treatments is safe for people using these new therapies.16789
Who Is on the Research Team?
Elisa Illing, MD
Principal Investigator
Indiana University
Are You a Good Fit for This Trial?
This trial is for adults over 18 with Cystic Fibrosis (CF) who are on highly effective modulator therapy (HEMT). They should have a history of chronic rhinosinusitis and be using nasal treatments like saline irrigations with or without steroids or antibiotics.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomly assigned to either continue or stop topical medicated nasal irrigations while on CFTR modulator therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including nasal leukosorb analyses and standard care evaluations
What Are the Treatments Tested in This Trial?
Interventions
- STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
American Rhinologic Society
Collaborator