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IPV vs CPT for Airway Clearance During CF Exacerbation

NCT03261219 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-10-19

No results posted yet for this study

Summary

Intrapulmonary Percussive Ventilation (IPV) will show greater improvements in Forced Expiatory Volume in 1 second (FEV1) shorter duration of stay, and greater time to next pulmonary exacerbation in pediatric Cystic Fibrosis patients admitted for pulmonary exacerbation.

FEV1 is a measurement of obstruction in the airway which is seen to be elevated in CF patients with worsening lung disease. FEV1 is used as a primary endpoint in pulmonary trials because it is an acute indicator of worsening or improving lung function.

Conditions

Interventions

DEVICE

Intrapulmonary Percussive ventilation

mode of airway clearance using mouthpiece and alternating air currents applied directly to the airway

DEVICE

Chest Physiotherapy Vest (Incourage)

mode of airway clearance using external vibratory vest

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2018-08-31
Completion
2018-10-30
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03261219 on ClinicalTrials.gov