Cystic Fibrosis Research Study
Researchers at Cincinnati Children’s Hospital are studying whether daily airway treatments are still necessary for children with cystic fibrosis in the era of highly effective modulators, using advanced MRI to monitor lung response.
Fast Facts
Individuals Ages 12-21 Diagnosed With Cystic Fibrosis
No Change In Therapies Or Medications In The Last 30 Days
Compensation
Provided
Conducted In
Cincinnati, OH
Study Background
Is a Reduction in Daily Airway Clearance Therapy Safe for Children with Cystic Fibrosis on New Medications?
Cystic fibrosis is a chronic genetic condition that affects about 30,000 people in the United States and causes thick, sticky mucus to build up in the lungs and other organs. Recently developed therapies, known as CFTR modulators, are now available to more than 90 percent of individuals with cystic fibrosis and have significantly improved the quality of life of children with cystic fibrosis. Despite these advances, many patients still follow time-consuming daily therapies, including airway clearance treatment, which can take up to two hours per day. As these new medications continue to transform care, families and medical providers are increasingly questioning how often airway clearance treatment should be performed.
The Regional Monitoring of Cystic Fibrosis study uses advanced hyperpolarized Xenon MRI, a safe and highly sensitive imaging tool that can detect subtle changes in lung function more precisely than traditional methods. Researchers will monitor individuals with cystic fibrosis who temporarily stop and then restart airway clearance treatment to observe how their lungs respond. Similarly, we will also observe individuals who temporarily start and then stop airway clearance treatment. The findings could help patients, families, and healthcare providers make more informed decisions about long-term care and possibly reduce the burden of daily therapies for individuals living with cystic fibrosis.
Study Background
Is a Reduction in Daily Airway Clearance Therapy Safe for Children with Cystic Fibrosis on New Medications?
Cystic fibrosis is a chronic genetic condition that affects about 30,000 people in the United States and causes thick, sticky mucus to build up in the lungs and other organs. Recently developed therapies, known as CFTR modulators, are now available to more than 90 percent of individuals with cystic fibrosis and have significantly improved the quality of life of children with cystic fibrosis. Despite these advances, many patients still follow time-consuming daily therapies, including airway clearance treatment, which can take up to two hours per day. As these new medications continue to transform care, families and medical providers are increasingly questioning how often airway clearance treatment should be performed.
The Regional Monitoring of Cystic Fibrosis study uses advanced hyperpolarized Xenon MRI, a safe and highly sensitive imaging tool that can detect subtle changes in lung function more precisely than traditional methods. Researchers will monitor individuals with cystic fibrosis who temporarily stop and then restart airway clearance treatment to observe how their lungs respond. Similarly, we will also observe individuals who temporarily start and then stop airway clearance treatment. The findings could help patients, families, and healthcare providers make more informed decisions about long-term care and possibly reduce the burden of daily therapies for individuals living with cystic fibrosis.
Additional Information
This study is being done to determine how much of a reduction in airway clearance treatment can doctors prescribe for children with cystic fibrosis now that highly effective modulators are available. Using advanced MRI, researchers aim to safely detect how the lung responds when these treatments are stopped and restarted.
You/your child may be eligible for this study if the following criteria is met:
Inclusion Criteria:
- Ages 12-21
- Diagnosed with cystic fibrosis
- Prescribed Mechanical Airway Clearance Therapy
- Able to undergo MRI scan (no metal in the body, no claustrophobia)
Exclusion Criteria:
- Change in therapies or medication in the last 30 days
- Recent flare-ups in relation to cystic fibrosis
- Lung, liver, or pancreatic diseases that are unrelated to cystic fibrosis
- Pregnant or breastfeeding
- Acute respiratory symptoms
Here’s what you/your child can expect if you/your child participates in the study:
Attend in-person visits at Cincinnati Children’s Hospital.
At each visit, your child will:
Undergo structural and functional imaging using Xenon MRI
Complete Pulmonary Function Testing
Complete Multiple Breath Washout (a detailed breathing test)
Between visits, you/your child will be asked to either increase or decrease airway clearance treatments at home, depending on the part of the study they are in.
Study visit schedule will depend on eligibility and interest:
Study Aim 1 involves one visit
Study Aims 2 and 3 each involve three visits
Participants who take part in two Aims (Aim 1 and either Aim 2 or Aim 3) will complete a total of four visits
You/your child will be paid $150 for each study visit. If you participate in two aims and complete all four visits, you can receive up to $600 in total compensation if all visits are complete.
There is no cost for you to participate in our research study.