Cystic Fibrosis Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Children and teenagers aged 6 to under 19 years old (for the main group and the non-HEMT group), or children aged 3 to under 6 years old (for the preschool group)
- You have been diagnosed with cystic fibrosis (CF), confirmed by a high salt level in a sweat test or by having two CF-causing gene changes
- You (or your parent/guardian) are willing and able to give written permission to participate, and you are able to follow the study requirements
- For the main group and preschool group: you have been taking a highly effective CF modulator therapy (a specific type of CF medication) for at least 3 months before joining
- For the non-HEMT group: you are either not eligible for highly effective modulator therapy based on your gene type, or you have not been taking it for at least 3 months and have no plans to start it in the next year, and you have also not been taking certain other CF medications (tezacaftor-ivacaftor or lumacaftor-ivacaftor) for at least 3 months
- For the main group and non-HEMT group: you are able to do a breathing test (spirometry) properly and consistently
- For the main group and non-HEMT group: your lung function score (ppFEV1) is at least 50% of what would be expected for someone your age and size
- You are able to receive text messages and access the internet
Who may not be able to join:
- You have a condition that the study doctor believes could put your safety at risk or affect the quality of the study results
- You are currently taking, or have taken in the past 14 days, a short course of antibiotics by mouth or through a drip (IV) — though you may be able to re-apply at least 21 days after finishing antibiotics if you are back to your usual health
- You are currently taking, or have taken in the past 14 days, steroid tablets or injections — though you may be able to re-apply at least 21 days after finishing steroids if you are back to your usual health
- You have previously had an organ transplant (such as a lung, liver, or kidney transplant)
- A specific type of bacterial infection called Mycobacterium abscessus was found in a test sample of yours in the past 12 months
- You are currently taking antibiotics to treat a type of bacterial infection called non-tuberculous mycobacteria (NTM)
- You have needed three or more hospital antibiotic drip (IV) treatments for CF flare-ups in the past 12 months
- You are currently taking long-term antibiotic tablets or capsules, other than a medication called azithromycin
- You have been treated with steroid tablets or injections for a lung condition called allergic bronchopulmonary aspergillosis (ABPA) in the past 12 months
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: D. B. Sanders, MD, MS, Indiana University
Phone: 206-897-1922
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
One-year change in pulmonary function by spirometry-measured ppFEV1
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.