Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis
Pilot Study of Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2024
CompletedFirst Posted
Study publicly available on registry
March 15, 2024
CompletedStudy Start
First participant enrolled
May 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2025
CompletedResults Posted
Study results publicly available
April 29, 2026
CompletedApril 29, 2026
February 1, 2026
10 months
March 7, 2024
January 27, 2026
April 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Sufficient Sputum Quantity for a Pellet
Percentage of patients with a successful culture result from sputum
10 minutes
Study Arms (1)
Intrapulmonary Percussive Ventilation for Non-sputum Producer
EXPERIMENTALUnable to produce adequate amount of lower airway bacterial sampling for culture results in last year.
Interventions
Intrapulmonary percussive ventilation for mobilizing mucus.
Eligibility Criteria
You may qualify if:
- years or older
- \. 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
You may not qualify if:
- \< 18 years old
- Sputum culture results in last one year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daniel J. Weinerlead
Study Sites (1)
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Daniel Weiner
- Organization
- UPMC Children's Hospital of Pittsburgh
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Weiner, MD
UPMC Children's Hospital of Pittsburgh
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- No parties will be prevented from having knowledge of the Volara System use.
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Pediatrics and Pediatric Pulmonologist
Study Record Dates
First Submitted
March 7, 2024
First Posted
March 15, 2024
Study Start
May 29, 2024
Primary Completion
March 19, 2025
Study Completion
March 19, 2025
Last Updated
April 29, 2026
Results First Posted
April 29, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
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.