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

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

Study Overview

• Status: Recruiting
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Device: Portable Internal Airway Percussion device; Device: Standard Airway Clearance device

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Hosford; Phone Number: 3523010676; Email: Jennifer.Hosford@peds.ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • UF Medical Plaza Pulmonary Clinic
      • Contact: Jennifer Hosford; Phone Number: 352-301-0676; Email: Jennifer.Hosford@peds.ufl.edu
      • Contact: SILVIA
      • Principal Investigator: DELGADO VILLALTA, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	14 days

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Silvia Delgado Villalta, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2021
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Airway Clearance
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: IRB201902662; OCR39724 (Other Identifier: UF Oncore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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