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NCT06311292 Clinical Trial

Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06311292
Other study ID # STUDY22090138
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date June 2025

Study information
Verified date May 2024
Source University of Pittsburgh
Contact Daniel Weiner, MD
Phone 412-692-8097
Email Daniel.Weiner@chp.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date June 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Volara System
Intrapulmonary percussive ventilation for mobilizing mucus.

Locations
Country Name City State
United States UPMC Presbyterian Hospital Pittsburgh Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Daniel J. Weiner

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sufficient sputum quantity for a pellet Percentage of patients with a successful culture result from sputum 10 minutes
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