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?

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 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+