Cystic Fibrosis
Conditions
Keywords
cystic fibrosis, Chest Wall Oscillation, drainage, postural, Medication Adherence, patient dropouts
Brief summary
The purpose of this study is to compare the effect of three airway secretion clearance techniques (chest physical therapy, flutter device and high frequency chest wall oscillation) on decline in pulmonary function over a three year period in patients with cystic fibrosis.
Detailed description
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.
Interventions
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.
DEVICEOscillatory 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.
OTHERPD&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.
Sponsors
Cystic Fibrosis Foundation
American Biosystems (currently Hill-Rom)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A proven diagnosis of CF as evidenced by a positive sweat test (as documented by a sweat chloride \>60 mEq/L by quantitative pilocarpine iontophoresis), or by the presence of two known CF mutations. * Aged 7 or older. * FEV1 \>45% (Knudson). * Able to perform reproducible maneuvers for spirometry at screening as defined by the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines. * Willing to participate in and comply with the study procedures, and willingness of a parent or legally authorized representative to provide written informed consent.
Exclusion criteria
* Hospitalization for complications of CF, or a respiratory exacerbation resulting in - treatment with IV antibiotics within 60 days prior to screening. * Use of any investigational drug or device within 60 days prior to screening. * An episode of gross hemoptysis (\>249 ml) within 60 days prior to screening, or during the course of the study. * A pneumothorax in the six months preceding the study or during the course of the study. * Patients who are pregnant or become pregnant. * Patients colonized with Burkholderia cepacia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of forced expiratory volume in 1 second (FEV1) decline | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| time to need for intravenous (IV) antibiotics to treat pulmonary exacerbations | 3 years |
| use of other pulmonary therapies | 3 years |
| adherence to therapy | 3 years |
| patient satisfaction | 3 years |
| health-related quality of life | 3 years |
Countries
United States
Outcome results
None listed