Airway Secretion Clearance in Cystic Fibrosis
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|ClinicalTrials.gov Identifier: NCT00839644|
Recruitment Status : Terminated (High dropout, problems recruiting, and smaller than expected decline in FEV1.)
First Posted : February 9, 2009
Last Update Posted : October 2, 2012
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Device: High frequency chest wall oscillation Device: Oscillatory Positive Expiratory Pressure Other: PD&P: Postural drainage and percussion||Not Applicable|
Study Design: Randomized clinical trial with pulmonary function testing obtained every three months in each of the three treatment groups. Change in slope of FEV1 will be compared. Days of hospitalization and use of oral or IV antibiotics for respiratory tract infection, quality of life, subject satisfaction, and compliance will also be compared.
Sample Size: Enrollment will be completed after 180 subjects have been recruited. Fifteen CF centers will participate.
Subject Selection: Subjects must have the diagnosis of CF, be > 7 years of age and have an FEV1 > 45% of predicted.
Prescribed Therapy: Each subject will receive airway secretion clearance twice a day.
Outcomes: Change in slope of FEV1; days of hospitalization and use of oral or IV antibiotics for respiratory tract infection; quality of life; subject satisfaction; compliance.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||166 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Airway Secretion Clearance in Cystic Fibrosis|
|Study Start Date :||December 1999|
|Actual Primary Completion Date :||December 2002|
|Actual Study Completion Date :||June 2003|
|Active Comparator: 2||
Device: Oscillatory Positive Expiratory Pressure
Therapy was prescribed twice daily for 20 minute sessions and included airway vibration, oscillating PEP, and forced expiratory technique (FET) with coughing.
Other Name: Flutter Device (Scandipharm, Birmingham, AL)
|Active Comparator: 3||
Other: PD&P: Postural drainage and percussion
Each of the six positions are to be clapped or vibrated for 4 minutes. After each position the patient is to do three forced expiratory techniques (FET) and cough, continue with FET and coughing until all mobilized mucus has been cleared.
Other Name: CPT
|Active Comparator: 1||
Device: High frequency chest wall oscillation
Therapy prescribed twce daily for twenty minute sessions. High frequency chest wall oscillation (HFCWO) applies sharp compression pulses via an air-pulse generator and inflatable vest. HFCWO generates transient increases in airflow at low lung volumes, cough-like shear forces, and alterations in the consistency of secretions.
Other Name: Vest
- rate of forced expiratory volume in 1 second (FEV1) decline [ Time Frame: 3 years ]
- time to need for intravenous (IV) antibiotics to treat pulmonary exacerbations [ Time Frame: 3 years ]
- use of other pulmonary therapies [ Time Frame: 3 years ]
- adherence to therapy [ Time Frame: 3 years ]
- patient satisfaction [ Time Frame: 3 years ]
- health-related quality of life [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00839644
|United States, Colorado|
|University of Colorado Denver and The Children's Hospital|
|Denver, Colorado, United States, 80045|
|Principal Investigator:||Frank J Accurso, MD||University of Colorado, Denver|