Back to resultsAirway Clearance for Pediatric and Adult Cystic Fibrosis Patients Using a Portable Intra-Pulmonary Percussion Device
Primary Purpose
Cystic Fibrosis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Airway Clearance device
Portable Internal Airway Percussion device
Sponsored by
About this trial
This is an interventional other trial for Cystic Fibrosis focused on measuring Airway Clearance
Eligibility Criteria
Inclusion Criteria:
- Ages 6-21 years
- Cystic fibrosis stable by physician assessment
- Assents to forego additional experimental treatments during the study
- Currently using and familiar with airway clearance therapy for treatment of cystic fibrosis
- Participant (or parent or legal guardian if the participant is a minor) is willing to provide -----InformedConsent
Exclusion Criteria:
- FEV1 < 40% predictive
- Pneumothorax
- Hemoptysis
- COVID-19 diagnosis within last 14 days
Any condition that, in the opinion of the investigator, would interfere with the study conduct or the safety of the participant
- Additional Exclusion Criteria: Outpatient Arm (in addition to general exclusion criteria above) Decrease in FEV1 > 10% from baseline over last 12 months Antibiotic Initiation for acute CF exacerbation Hospitalization for CF Exacerbation
- Additional Exclusion Criteria: Inpatient Arm (in addition to general exclusion criteria above) Failure to increase FEV1 > 10 % from initial PFTs on admission by day 9 of hospitalization.
Sites / Locations
- UF Medical Plaza Pulmonary ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PIAPD-Portable Internal Airway Percussion device
SACD-Standard Airway Clearance device
Arm Description
There will be an Inpatient Arm and Outpatient Arm using the Smart One® portable home spirometer
There will be an Inpatient Arm and Outpatient Arm using the SACD. A large majority of patients will be using VEST therapy as their standard of care airway clearance. A few might be using an Intrapulmonary Percussion Device that uses a mechanism different from the device the study will be testing.
Outcomes
Primary Outcome Measures
To measure the number of cystic fibrosis patients perception of breathing effort and device use
The number of cystic fibrosis patients perception of their breathing effort and device use
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04743206
Brief Title
Airway Clearance for Pediatric and Adult Cystic Fibrosis Patients Using a Portable Intra-Pulmonary Percussion Device
Official Title
Airway Clearance for Pediatric and Adult Cystic Fibrosis Patients Using a Portable Intra-Pulmonary Percussion Device (PIAPD)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2021 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
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.
Yes
5. Study Description
Brief Summary
This is a pilot study where the investigators aim to compare initial use of the standard airway clearance device (SACD) with subsequent use of a Portable Intra-Pulmonary Percussion Device (PIAPD) in patients with cystic fibrosis ages 6 -21 years. The primary hypothesis is that there is no effect of PIAPD on FEV1 2 hours after use, there is no effect on perception of effort and efficacy for the PIAPD. If both are equally effective, the latter device provides an alternative that is both cheaper and portable.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Airway Clearance
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a pilot study where the investigators aim to compare initial use of the standard airway clearance device (SACD) with subsequent use of a PIAPD in patients with stable cystic fibrosis ages 6 -21 years. The primary hypothesis (Stated as Null) being that there is no effect of PIAPD on FEV1 2 hours after use, there is no effect on perception of effort and efficacy for the PIAPD.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PIAPD-Portable Internal Airway Percussion device
Arm Type
Experimental
Arm Description
There will be an Inpatient Arm and Outpatient Arm using the Smart One® portable home spirometer
Arm Title
SACD-Standard Airway Clearance device
Arm Type
Active Comparator
Arm Description
There will be an Inpatient Arm and Outpatient Arm using the SACD.
A large majority of patients will be using VEST therapy as their standard of care airway clearance. A few might be using an Intrapulmonary Percussion Device that uses a mechanism different from the device the study will be testing.
Intervention Type
Device
Intervention Name(s)
Standard Airway Clearance device
Intervention Description
A large majority of our patients will be using VEST therapy as their standard of care airway clearance
Intervention Type
Device
Intervention Name(s)
Portable Internal Airway Percussion device
Intervention Description
Smart One® portable home spirometer
Primary Outcome Measure Information:
Title
To measure the number of cystic fibrosis patients perception of breathing effort and device use
Description
The number of cystic fibrosis patients perception of their breathing effort and device use
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages 6-21 years
Cystic fibrosis stable by physician assessment
Assents to forego additional experimental treatments during the study
Currently using and familiar with airway clearance therapy for treatment of cystic fibrosis
Participant (or parent or legal guardian if the participant is a minor) is willing to provide -----InformedConsent
Exclusion Criteria:
FEV1 < 40% predictive
Pneumothorax
Hemoptysis
COVID-19 diagnosis within last 14 days
Any condition that, in the opinion of the investigator, would interfere with the study conduct or the safety of the participant
Additional Exclusion Criteria: Outpatient Arm (in addition to general exclusion criteria above) Decrease in FEV1 > 10% from baseline over last 12 months Antibiotic Initiation for acute CF exacerbation Hospitalization for CF Exacerbation
Additional Exclusion Criteria: Inpatient Arm (in addition to general exclusion criteria above) Failure to increase FEV1 > 10 % from initial PFTs on admission by day 9 of hospitalization.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Hosford
Phone
3523010676
Email
Jennifer.Hosford@peds.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Delgado Villalta, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Medical Plaza Pulmonary Clinic
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Hosford
Phone
352-301-0676
Email
Jennifer.Hosford@peds.ufl.edu
First Name & Middle Initial & Last Name & Degree
SILVIA
First Name & Middle Initial & Last Name & Degree
DELGADO VILLALTA, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Airway Clearance for Pediatric and Adult Cystic Fibrosis Patients Using a Portable Intra-Pulmonary Percussion Device
We'll reach out to this number within 24 hrs