Volara System for Cystic Fibrosis

No longer recruiting at 1 trial location

Overseen By Daniel Weiner, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Daniel J. Weiner

Must be taking: Hypertonic saline

Disqualifiers: Under 18, Sputum culture results

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

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. ^{1 2 3 4 5}

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. ^{4 6 7 8 9}

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

No sputum culture results in last one year or those who were unable to produce sputum from VPEP method used in QI project 3771

I use hypertonic saline for my lung therapy.

Exclusion Criteria

I am under 18 years old.

Sputum culture results in last one year

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use the Volara System during a clinic visit to attempt sputum production

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Volara MetaNeb System

Trial Overview

The trial is testing the effectiveness of the Volara MetaNeb System in helping patients with Cystic Fibrosis produce sputum during a clinic visit. It's a small pilot study aimed at improving sputum collection methods.

How Is the Trial Designed?

Group I: Intrapulmonary Percussive Ventilation for Non-sputum Producer Experimental Treatment 1 Intervention

Unable to produce adequate amount of lower airway bacterial sampling for culture results in last year.

Volara MetaNeb System is already approved in United States for the following indications:

Approved in United States as Volara System for:

• Mobilization of secretions
• Lung expansion therapy
• Pulmonary atelectasis treatment

Who Is Running the Clinical Trial?

Daniel J. Weiner

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

Nebulised hypertonic saline significantly improves mucociliary clearance in cystic fibrosis patients, with immediate effects observed in trials involving 143 subjects, leading to a notable increase in lung function (FEV1) by 15% compared to isotonic saline.

Despite the positive effects on mucociliary clearance and lung function, the studies were limited to a maximum duration of three weeks, and further research is needed to assess long-term benefits and safety, particularly in patients with severe lung disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nebulised hypertonic saline for cystic fibrosis. Wark, PA., McDonald, V.[2018]

Endonasal fenetration is recommended for patients with cystic fibrosis to enhance the efficiency of aerosol treatments on the nasal mucosa.

This method also improves the effectiveness of swab and rinsing treatments for chronic sinusitis maxillaris associated with cystic fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Aerosoltherapy and operative aspects in cystic fibrotic children with sinusitis maxillaris (author's transl)]. Werner, E.[2006]

Inhaled medications like hypertonic saline and dornase alfa can significantly improve lung function in children with cystic fibrosis by enhancing mucociliary clearance and reducing pulmonary disease exacerbations, with minimal side effects.

These treatments work by rehydrating airway surfaces and breaking down extracellular DNA, which helps address airway obstruction, inflammation, and infection—key factors in the progression of lung disease in cystic fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhaled medications in cystic fibrosis beyond antibiotics. Sepe, A., Villella, VR., Cimbalo, C., et al.[2019]

Cystic fibrosis is a genetic disease that leads to chronic lung infections and digestive issues, primarily caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, affecting 1 in 20 Caucasians.

Recent advancements in treatment, including antibiotics, enzyme replacements, and lung transplants, have significantly improved life expectancy for cystic fibrosis patients, projected to rise from 28 years in the 1990s to 40 years in the next two decades.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mucoviscidosis: Background, risk factors, diagnosis strategy, treatment principles]. Trofor, A.[2011]

The review identified only one relevant study involving 28 participants, which compared nasal irrigation alone to nasal irrigation with endoscopic sinus surgery, but the evidence was rated as very low certainty, making it unclear if surgery improves nasal symptoms or reduces complications in cystic fibrosis patients with chronic rhinosinusitis and nasal polyposis.

There was one reported episode of bleeding during surgery, which was managed without further issues, indicating that while surgery may carry risks, the immediate safety profile appears manageable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgery for nasal polyposis in cystic fibrosis. Almeida, PRL., Person, OC., Puga, ME., et al.[2023]

Citations

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Volara System for Cystic Fibrosis · Info for Participants

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This paper reviews strategies for ACT. It is specifically targeted for clinicians who frequently provide care for patients with CF.

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The Volara system is a relatively new method of treating CF and bronchiectasis patients that provides alternating cycles of continuous positive ...

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The Volara System is cleared by the FDA to mobilize secretions, provide lung expansion therapy for the treatment and prevention of pulmonary atelectasis, and ...

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The volara system is intended for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and has the ...

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PURPOSE: The Volara™ System is a novel device that is intended for the mobilization of secretions, lung expansion therapy, and the treatment and prevention ...