Airway Secretion Clearance in Cystic Fibrosis

• time to need for intravenous (IV) antibiotics to treat pulmonary exacerbations [ Time Frame: 3 years ] [ Designated as safety issue: No ]
• use of other pulmonary therapies [ Time Frame: 3 years ] [ Designated as safety issue: No ]
• adherence to therapy [ Time Frame: 3 years ] [ Designated as safety issue: No ]
• patient satisfaction [ Time Frame: 3 years ] [ Designated as safety issue: No ]
• health-related quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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.

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.

• 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
• 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)
• 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: 2
  Intervention: Device: Oscillatory Positive Expiratory Pressure
• Active Comparator: 3
  Intervention: Other: PD&P: Postural drainage and percussion
• Active Comparator: 1
  Intervention: Device: High frequency chest wall oscillation

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.

• Cystic Fibrosis Foundation
• American Biosystems (currently Hill-Rom)