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New breathing device may help CF patients produce mucus for testing

NCT ID NCT06311292

Knowledge-focused Sponsor: Daniel J. Weiner Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This small pilot study tested whether a breathing device called the Volara System could help adults with cystic fibrosis produce sputum (mucus from the lungs) for lab testing. The study included 20 people who had not been able to produce a sputum sample in the past year. Participants used the device during a clinic visit to try to loosen and collect mucus. The goal was to see if this method could provide enough sputum for a successful culture result.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Volara System (a breathing device that delivers gentle air pulses to loosen mucus)
What this could lead to
If successful, this method could give doctors a better way to collect sputum for infection testing in people with cystic fibrosis who struggle to cough up mucus.
What could go wrong
This is a very small pilot study (20 people) with no comparison group, so results may not apply to everyone. The device may not work for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

May 2024

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 18 years or older 2. 2\. Currently prescribed hypertonic saline treatment as part of routine airway clearance therapy. 2\. No sputum culture results in last one year or those who were unable to produce sputum from VPEP method used in QI project 3771 Exclusion Criteria: 1. \< 18 years old 2. Sputum culture results in last one year

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Conditions

The condition(s) this trial relates to.

cystic fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis

Contacts and locations

Locations

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.