Phase 4
N=17
Comparison of Airway Clearance Therapy in Cystic Fibrosis Using the Same VEST Therapy Device But With Different Settings
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00685035 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Sputum Wet and Dry Weight — 6.4; 4.8; 0.20; 0.12 grams — p=.02
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- HFCWC with higher pressure/variable-frequency settings (Device); HFCWC with lower pressure/mid-frequency settings (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sputum Wet and Dry Weight |
6.4; 4.8; 0.20; 0.12 | .02 sig |
| SECONDARY Pre vs. Post Therapy Spirometry |
70; 90; 80; 80 | — |
| SECONDARY Rheology and in Vitro Cough Transportability of Sputum Produced Immediately Following Airway Clearance Therapy Session |
4.43; 4.61; 107.3; 130.7; 10.7; 7.4 | — |
| SECONDARY Patients' Perceived Comfort Using the Different Settings for the Vest Device |
4.5; 5; 4; 4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of CF established by sweat chloride > 60 mmol/L.
- Age older than 18 years.
- History of chronic daily sputum production.
- Currently on a home therapeutic regimen that includes some form of airway clearance performed with a HFCWO device at least once daily that also includes concomitant use of an inhaled mucolytic and inhaled bronchodilator.
- FVC and FEV1 > 40%-predicted, and with stable lung function (no greater than a 10% variation in lung function parameters over the preceding 3 months).
- Evaluated at the University of Minnesota CF Center 3 or more times in the preceding 12 months.
Exclusion criteria
- Hospitalization for CF pulmonary complications in the 2 months preceding enrollment.
- Hemoptysis > 60 cc in a single episode in the 4 weeks preceding enrollment.
- Chest pain requiring use of narcotic for pain control.
- Current participation in another clinical trial.
- Use of intravenous antibiotics for CF respiratory complications in the 2 months preceding enrollment.
- No prior experience using HFCWO devices for airway clearance
Data sourced from ClinicalTrials.gov (NCT00685035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.