Airway Clearance for Pediatric and Adult Cystic Fibrosis Patients Using a Portable Intra-Pulmonary Percussion Device

Sponsor

University of Florida (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04743206

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

18.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Device: Standard Airway Clearance device Device: Portable Internal Airway Percussion device	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Other

Official Title:

Airway Clearance for Pediatric and Adult Cystic Fibrosis Patients Using a Portable Intra-Pulmonary Percussion Device (PIAPD)

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PIAPD-Portable Internal Airway Percussion device There will be an Inpatient Arm and Outpatient Arm using the Smart One® portable home spirometer	Device: Portable Internal Airway Percussion device Smart One® portable home spirometer
Active Comparator: SACD-Standard Airway Clearance device 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.	Device: Standard Airway Clearance device A large majority of our patients will be using VEST therapy as their standard of care airway clearance

Arm

Intervention/Treatment

Experimental: PIAPD-Portable Internal Airway Percussion device

There will be an Inpatient Arm and Outpatient Arm using the Smart One® portable home spirometer

Device: Portable Internal Airway Percussion device

Smart One® portable home spirometer

Active Comparator: SACD-Standard Airway Clearance device

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.

Device: Standard Airway Clearance device

A large majority of our patients will be using VEST therapy as their standard of care airway clearance

Outcome Measures

Primary Outcome Measures

To measure the number of cystic fibrosis patients perception of breathing effort and device use [14 days]
The number of cystic fibrosis patients perception of their breathing effort and device use

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UF Medical Plaza Pulmonary Clinic	Gainesville	Florida	United States	32610

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator: Silvia Delgado Villalta, MD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Florida

ClinicalTrials.gov Identifier:

NCT04743206

Other Study ID Numbers:

IRB201902662
OCR39724

First Posted:

Feb 8, 2021

Last Update Posted:

Nov 23, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by University of Florida

Airway Clearance

Additional relevant MeSH terms:

Cystic Fibrosis

Fibrosis

Study Results

No Results Posted as of Nov 23, 2021