Sinonasal Therapies for Cystic Fibrosis

Overseen By Elisa Illing, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Indiana University

Must be taking: Highly effective modulators

Must not be taking: Oral antibiotics

Disqualifiers: Pregnancy, Tumors, Active infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

64 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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

I have been diagnosed with Cystic Fibrosis.

I have a history of long-term sinus infections.

I use nasal rinses with or without added medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either continue or stop topical medicated nasal irrigations while on CFTR modulator therapy

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including nasal leukosorb analyses and standard care evaluations

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

Trial Overview

The study aims to determine if CF patients on HEMT can safely stop standard sinonasal therapies, such as high-volume nasal saline irrigation, topical nasal steroids, and antibiotics. It includes tests like endoscopy and questionnaires to assess the impact of discontinuing these treatments.

How Is the Trial Designed?

Group I: STOP TOPICAL NASAL TREATMENT Experimental Treatment 7 Interventions

PARTICIPANTS IN THIS ARM WILL BE ASKED TO STOP THEIR NASAL TREATMENT

Group II: CONTINUE TOPICAL STEROID NASAL IRRIGATION Active Control 1 Intervention

PARTICIPANTS WILL CONTINUE THEIR NASAL TREATMENT WHICH WAS ALREADY PRESCRIBED BY THEIR PHYSICIAN

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

American Rhinologic Society

Collaborator

Trials

2

Recruited

40+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10083096/

The Management of Cystic Fibrosis Chronic Rhinosinusitis

Based on the currently available evidence, nasal saline, ESS, and CFTR modulators are recommended in the management of CF CRS when appropriate.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03145051

Efficacy of Nasal Irrigation With Respimer® Netiflow® vs ...

Efficacy of Nasal Irrigation With Respimer® Netiflow® vs Saline Among Patients With Cystic Fibrosis and Chronic Rhinosinusitis (Respire). ClinicalTrials.gov ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1808869424001320

Review article Effectiveness of hypertonic saline irrigation ...

Hypertonic saline showed a superior improvement in postoperative evaluation by means of nasal crusting, mucosal healing aspect, and nasal inflammatory symptoms

4.

withpower.com

withpower.com/trial/phase-cystic-fibrosis-4-2025-e4ab3

Sinonasal Therapies for Cystic Fibrosis

Trial Overview The study aims to determine if CF patients on HEMT can safely stop standard sinonasal therapies, such as high-volume nasal saline irrigation, ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6805252/

Medical interventions for chronic rhinosinusitis in cystic fibrosis

Nasal saline irrigation physically removes viscous mucus that impairs the clearance of debris and bacteria. Hypertonic saline could have the additional benefit ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03145051

Efficacy of Nasal Irrigation With Respimer® Netiflow® vs ...

Efficacy of Nasal Irrigation With Respimer® Netiflow® vs Saline Among Patients With Cystic Fibrosis and Chronic Rhinosinusitis (Respire). ClinicalTrials.gov ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8901942/

Clinical Practice Guideline: Nasal Irrigation for Chronic ...

The study outcomes showed that steroid nasal irrigation improved patients' symptoms and endoscopic and radiologic scores compared to steroid nasal spray [67].

8.

jamanetwork.com

jamanetwork.com/journals/jamaotolaryngology/fullarticle/484888

Nasal Saline for Chronic Sinonasal Symptoms

Furthermore, the irrigation group experienced 50% lower odds of frequent nasal symptoms compared with the spray group. The baseline severity of nasal and sinus ...

9.

sciencedirect.com

sciencedirect.com/science/article/pii/S1879729615001003

Review Nasal irrigation: From empiricism to evidence ...

Regular saline irrigation in adults and children improved nasal symptomatology in 35% of cases and quality of life in 30%. Mucociliary clearance on saccharine ...