Volara System for Cystic Fibrosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial seeks a better method to collect sputum (a mixture of saliva and mucus) from individuals with cystic fibrosis who cannot produce it independently. Researchers are testing the Volara MetaNeb System, which uses gentle air pressure to help clear the airways. Individuals who have used hypertonic saline for airway clearance without producing sputum in the past year may be suitable candidates. Participants will use the system during a clinic visit to determine its effectiveness in producing sputum. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance airway clearance techniques for cystic fibrosis patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it requires that you are currently using hypertonic saline treatment as part of your routine therapy.
What prior data suggests that the Volara System is safe for sputum collection in Cystic Fibrosis patients?
Research has shown that the FDA approved the Volara System to help clear mucus and improve lung function, indicating it met safety standards for these uses. However, a recall occurred because the device could cause breathing problems in some cases, highlighting past safety concerns. Prospective trial participants should consider this information. Discuss potential risks and benefits with a healthcare provider before making a decision.12345
Why are researchers excited about this trial?
The Volara MetaNeb System is unique because it uses Intrapulmonary Percussive Ventilation (IPV), a technique designed specifically for people with cystic fibrosis who struggle to produce sputum for bacterial cultures. Unlike traditional chest physiotherapy or high-frequency chest wall oscillation, which rely on mechanical vibrations to loosen mucus, IPV delivers rapid bursts of air directly into the lungs to help mobilize secretions. Researchers are excited about this approach because it could improve airway clearance and ultimately lead to better infection management for patients who haven't had success with existing options.
What evidence suggests that the Volara System is effective for sputum collection in Cystic Fibrosis patients?
Research shows that the Volara MetaNeb System, used by participants in this trial, can help people with Cystic Fibrosis clear their lungs. One study found it improved lung clearance in patients experiencing sudden flare-ups of Cystic Fibrosis. This system employs special methods to move mucus out of the lungs, a common challenge for Cystic Fibrosis patients. Another study demonstrated that it reduces lung problems after surgery in high-risk patients. These findings suggest it could effectively aid in mucus production, addressing a challenge for some Cystic Fibrosis patients.46789
Who Is on the Research Team?
Daniel Weiner, MD
Principal Investigator
UPMC Children's Hospital of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for adults with Cystic Fibrosis who struggle to produce sputum. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors that could interfere with the study or their safety.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the Volara System during a clinic visit to attempt sputum production
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Volara MetaNeb System
Volara MetaNeb System is already approved in United States for the following indications:
- Mobilization of secretions
- Lung expansion therapy
- Pulmonary atelectasis treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Daniel J. Weiner
Lead Sponsor