Hyperpolarized Xe129 for Cystic Fibrosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new tests for monitoring lung changes in individuals with Cystic Fibrosis (CF). Researchers focus on how stopping and starting a breathing exercise called Airway Clearance Therapy (ACT) affects these tests. Participants will undergo an MRI scan using a special gas called Xenon, which provides clearer images of the lungs, and a Lung Clearance Index (LCI) test that assesses lung function. This study may suit individuals aged 12-21 with CF who are currently stable and already using Mechanical ACT.
As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance CF management.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it does require no changes in chronic maintenance therapies in the 28 days before joining. It's best to discuss with the trial team and your doctor.
What prior data suggests that these new tests for Cystic Fibrosis are safe?
Research has shown that mechanical airway clearance therapy (ACT) devices are generally safe for people with cystic fibrosis (CF). These devices help remove mucus from the lungs, which is crucial for maintaining lung health. Most patients tolerate ACT well, though some might experience mild discomfort.
Research also supports using hyperpolarized xenon (Xe) gas in MRI scans for lung imaging. The FDA has already approved Xe gas for lung ventilation MRI. The new Xe MRI techniques in this study resemble those already used in medical settings, suggesting they are likely safe. However, these specific techniques are still under study and not yet FDA-approved. Previous research, particularly at Cincinnati Children's Hospital, has demonstrated the safe use of these techniques for many years.
Overall, these treatments in the study have a history of being well-tolerated in research settings.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it focuses on using Mechanical Airway Clearance Therapy (MACT) in a targeted way to monitor and manage cystic fibrosis (CF) lung disease. Unlike traditional treatments like chest physiotherapy or vibrating vests, which provide general airway clearance, this method aims to optimize the effectiveness of airway clearance by honing in on regional lung function. The goal is to better understand how different areas of the lungs respond to therapy, potentially leading to more personalized and effective treatment plans for young CF patients. This approach could revolutionize how we monitor and treat CF, offering hope for improved outcomes.
What evidence suggests that these new tests are effective for measuring lung changes in Cystic Fibrosis?
Research has shown that airway clearance therapy, which uses devices to help clear mucus from the lungs, can lead to short-term improvements in lung function for people with cystic fibrosis (CF). One study found that most patients experienced better lung function after therapy. However, other studies have shown mixed results, with some finding no significant improvement. Effectiveness can vary from person to person, and no single method has been proven best. Overall, airway clearance therapy can be helpful, but its impact may differ for each individual. Participants in this trial will be those prescribed Mechanical Airway Clearance Therapy for CF.23467
Who Is on the Research Team?
Jason C Woods, PhD
Principal Investigator
Cincinnati Children's Hospital Medica Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline visit using UTE and Xenon MRI, spirometry, and multiple-breath washout
Treatment
Examine lung function decline after airway clearance techniques (ACT) withdrawal
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Hyperpolarized Xe129
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
To perform a stepwise ACT re-initiation trial in fifteen 12-21 y.o. patients who have self-withdrawn airway clearance treatment (defined as ≤ 3x/week). UTE and Xe MRI, spirometry, and multiple-breath washout will be performed at baseline, after increasing treatment to 7x/week for 1 week and then 14x/week for 2 weeks, with daily logging to aid compliance and study engagement.
To perform a stepwise ACT withdrawal trial in fifteen 12-21 y.o. patients who have low MRI abnormalities and high FEV1. Patients will be studied at baseline, after decreasing ACT to 7x/week for 1 week, and after decreasing ACT to 3x/week for 1 week.
Males and females from 12 to 21 years old who have been prescribed Mechanical Airway Clearance Therapy for CF.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
Citations
Airway clearance techniques for cystic fibrosis: an overview ...
There is little evidence to suggest that any particular airway clearance therapy is more effective at reducing the number or frequency of exacerbations.
Comparative Effects of Mechanical and Manual Airway ...
Various studies have yielded inconsistent results regarding the comparative effectiveness of manual versus mechanical airway clearance techniques in improving ...
Short-term structural and functional changes after airway ...
In the case of FEV1,pp, a large majority of patients' FEV1,pp improved (15 increased, 4 decreased, 1 remained the same). This is in line with earlier studies ...
Effect of airway clearance therapies on mucociliary clearance ...
We designed a randomized controlled trial to quantitatively compare the effects of different forms of airway clearance on mucociliary clearance.
Airway clearance techniques compared to ... - PubMed Central
Only one study reported an improvement in lung function in some of the treatment groups, whilst six other studies found no improvement. This review found that ...
Airway Clearance Devices for Cystic Fibrosis
The purpose of this evidence-based analysis is to examine the safety and efficacy of airway clearance devices (ACDs) for cystic fibrosis.
Chest Physiotherapy and Airway Clearance Devices
High-frequency chest wall oscillation (HFCWO) is used in CF, but tolerability and safety data in cerebral palsy and neuromuscular disease are limited. These ...
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