Recruiting PHASE3 Cystic Fibrosis (CF)

New treatment option for Cystic Fibrosis (CF)

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

ClinicalTrials.gov ID: NCT06996951

What this study is testing

What is CONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID?

CONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for cystic fibrosis (cf).

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Age 18 or older
  • Cystic Fibrosis diagnosis on HEMT
  • History of chronic rhinosinusitis
  • Using topical nasal irrigations +/- additives (steroids, antibiotics)

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • Age 18 or older
  • Cystic Fibrosis diagnosis on HEMT
  • History of chronic rhinosinusitis
  • Using topical nasal irrigations +/- additives (steroids, antibiotics)
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Indianapolis, Indiana, United States

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Indianapolis, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.