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

Overview

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.

Full Title of Study: “Airway Clearance for Pediatric and Adult Cystic Fibrosis Patients Using a Portable Intra-Pulmonary Percussion Device (PIAPD)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2023

Interventions

  • Device: Standard Airway Clearance device
    • A large majority of our patients will be using VEST therapy as their standard of care airway clearance
  • Device: Portable Internal Airway Percussion device
    • Smart One® portable home spirometer

Arms, Groups and Cohorts

  • Experimental: PIAPD-Portable Internal Airway Percussion device
    • There will be an Inpatient Arm and Outpatient Arm using the 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.

Clinical Trial Outcome Measures

Primary Measures

  • To measure the number of cystic fibrosis patients perception of breathing effort and device use
    • Time Frame: 14 days
    • The number of cystic fibrosis patients perception of their breathing effort and device use

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 21 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Florida
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Silvia Delgado Villalta, MD, Principal Investigator, University of Florida
  • Overall Contact(s)
    • Jennifer Hosford, 3523010676, Jennifer.Hosford@peds.ufl.edu

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