Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis

April 8, 2026 updated by: Daniel J. Weiner

Pilot Study of Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis

This is a small pilot study with the goal of identifying a superior sputum collection method in Cystic Fibrosis patients unable to produce a sputum.

Participants will use the Volara System during clinic visit in an attempt to produce sputum.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Since the introduction of CFTR modulator therapies, most patients with Cystic Fibrosis (CF) have been unable to produce an adequate sputum sample for clinical monitoring. COVID-19 also presented a safety concern for staff and patients that may become exposed during sputum induction performed in the clinic rooms due to lack of negative pressure rooms and especially for patients who were unvaccinated. These issues led to lack of microbiology data for clinical care.

The purpose of this project is to identify a superior sputum collection method for those patients unable to produce a sputum to guide future antimicrobial management.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intrapulmonary Percussive Ventilation for Non-sputum Producer
Unable to produce adequate amount of lower airway bacterial sampling for culture results in last year.
Device: Volara System
Intrapulmonary percussive ventilation for mobilizing mucus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sufficient Sputum Quantity for a Pellet
Time Frame: 10 minutes
Percentage of patients with a successful culture result from sputum
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniel J. Weiner

Investigators

  • Principal Investigator: Daniel Weiner, MD, UPMC Children's Hospital of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2024

Primary Completion (Actual)

March 19, 2025

Study Completion (Actual)

March 19, 2025

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY22090138

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators do not currently have an individual participant data sharing plan. However, de-identified research data/documents may be shared in the future with other investigators who share similar research interests.

Specimens and data will not be released without (1) PI written permission and (2) appropriate Institutional Review Board (IRB) approval. Data use and/or material transfer agreements will also be required as applicable to outside researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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