Airway Secretion Clearance in Cystic Fibrosis

Sponsor

University of Colorado, Denver (Other)

Overall Status

Terminated

CT.gov ID

NCT00839644

Collaborator

Cystic Fibrosis Foundation (Other), American Biosystems (currently Hill-Rom) (Other)

166

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

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	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

166 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Airway Secretion Clearance in Cystic Fibrosis

Study Start Date :

Dec 1, 1999

Actual Primary Completion Date :

Dec 1, 2002

Actual Study Completion Date :

Jun 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: 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 Names: Vest

Arm

Intervention/Treatment

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 Names:

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 Names:

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 Names:

Vest

Outcome Measures

Primary Outcome Measures

rate of forced expiratory volume in 1 second (FEV1) decline [3 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.