Airway Secretion Clearance in Cystic Fibrosis

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 Overview

• Status: Terminated
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Device: Oscillatory Positive Expiratory Pressure; Other: PD&P: Postural drainage and percussion; Device: High frequency chest wall oscillation

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 Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80045
      • University of Colorado Denver and The Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
rate of forced expiratory volume in 1 second (FEV1) decline	3 years

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Cystic Fibrosis Foundation; American Biosystems (currently Hill-Rom)
• Investigators: Principal Investigator: Frank J Accurso, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: December 1, 1999
• Primary Completion (ACTUAL): December 1, 2002
• Study Completion (ACTUAL): June 1, 2003

Study Registration Dates

• First Submitted: February 5, 2009
• First Submitted That Met QC Criteria: February 6, 2009
• First Posted (ESTIMATE): February 9, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): October 2, 2012
• Last Update Submitted That Met QC Criteria: October 1, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: cystic fibrosis; Medication Adherence; Chest Wall Oscillation; drainage, postural; patient dropouts
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 06-0609; ACCURS98A0 (OTHER_GRANT: Cystic Fibrosis Foundation)