Status:
COMPLETED
Comparison of Airway Clearance Therapy in Cystic Fibrosis Using the Same VEST Therapy Device But With Different Settings
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Hill-Rom
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 p...
Detailed Description
Patients with cystic fibrosis (CF) perform daily airway clearance therapy to facilitate removal of secretions from their airways. Many different techniques are available to achieve this and there is c...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00685035
Start Date
May 1 2008
End Date
October 1 2008
Last Update
July 25 2016
Active Locations (1)
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1
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455