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.

Completed

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 years or older
2. Currently prescribed hypertonic saline treatment as part of routine airway clearance therapy.

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

< 18 years old
Sputum culture results in last one year

Treatment and study plan

Volara System

Device

Intrapulmonary percussive ventilation for mobilizing mucus.

Primary outcomes

Sufficient Sputum Quantity for a Pellet

Time frame: 10 minutes

Percentage of patients with a successful culture result from sputum

Sponsors and collaborators

Lead sponsor

Daniel J. Weiner

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Mar 15, 2024
Registry last updated: Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed