CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 17 enrolled
Drug / intervention
HFCWC with higher pressure/variable-frequency settings +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00685035
NCT00685035Phase 4Completed

Comparison of Sine Waveform High Frequency Chest Wall Oscillation Using Different Settings in Cystic Fibrosis

University of Minnesota·interventional·Posted May 28, 2008·Updated Jul 25, 2016

In Brief

A Phase 4 clinical trial evaluating HFCWC with higher pressure/variable-frequency settings and HFCWC with lower pressure/mid-frequency settings for Cystic Fibrosis. Completed, enrolled 17 participants across 1 site.

Detailed Summary

Our primary hypothesis is that airway clearance therapy with sine waveform HFCWO using higher inflation pressures combined with both low and high oscillator frequencies will result in greater sputum production compared to sine waveform HFCWO with lower inflation pressures and mid-frequency oscillations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited States
CollaboratorsHill-Rom

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 28, 2008
Enrollment StartMay 1, 2008
Primary CompletionAug 1, 2008
Study CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 18.1 years ago

Interventions

HFCWC with higher pressure/variable-frequency settingsdevice

Randomized crossover trial of airway clearance therapy comparing sine wave HFCWO with high pressures and variable frequency (pressure 10, frequencies 8,9,10 and pressure 6, frequencies 18,19,20) to low pressure and mid frequency (pressure 5, frequency 12). Subjects will have 2-day washout between airway clearance sessions. All sputum collected during sessions.

HFCWC with lower pressure/mid-frequency settingsdevice

Subjects will perform pulmonary function tests prior to and following each airway clearance therapy. All sputum produced during, and for 15 minutes following airway clearance therapy will be collected. Subjects will complete a questionnaire addressing the comfort of therapy upon completion of the session.