Back to resultsAirway Secretion Clearance in Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High frequency chest wall oscillation
Oscillatory Positive Expiratory Pressure
PD&P: Postural drainage and percussion
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring cystic fibrosis, Chest Wall Oscillation, drainage, postural, Medication Adherence, patient dropouts
Eligibility Criteria
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.
Sites / Locations
- University of Colorado Denver and The Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
2
3
1
Arm Description
Outcomes
Primary Outcome Measures
rate of forced expiratory volume in 1 second (FEV1) decline
Secondary Outcome Measures
time to need for intravenous (IV) antibiotics to treat pulmonary exacerbations
use of other pulmonary therapies
adherence to therapy
patient satisfaction
health-related quality of life
Full Information
NCT ID
NCT00839644
First Posted
February 5, 2009
Last Updated
October 1, 2012
Sponsor
University of Colorado, Denver
Collaborators
Cystic Fibrosis Foundation, American Biosystems (currently Hill-Rom)
1. Study Identification
Unique Protocol Identification Number
NCT00839644
Brief Title
Airway Secretion Clearance in Cystic Fibrosis
Official Title
Airway Secretion Clearance in Cystic Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
High dropout, problems recruiting, and smaller than expected decline in FEV1.
Study Start Date
December 1999 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
June 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Cystic Fibrosis Foundation, American Biosystems (currently Hill-Rom)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
cystic fibrosis, Chest Wall Oscillation, drainage, postural, Medication Adherence, patient dropouts
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Arm Title
1
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
High frequency chest wall oscillation
Other Intervention Name(s)
Vest
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Oscillatory Positive Expiratory Pressure
Other Intervention Name(s)
Flutter Device (Scandipharm, Birmingham, AL)
Intervention Description
Therapy was prescribed twice daily for 20 minute sessions and included airway vibration, oscillating PEP, and forced expiratory technique (FET) with coughing.
Intervention Type
Other
Intervention Name(s)
PD&P: Postural drainage and percussion
Other Intervention Name(s)
CPT
Intervention Description
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.
Primary Outcome Measure Information:
Title
rate of forced expiratory volume in 1 second (FEV1) decline
Time Frame
3 years
Secondary Outcome Measure Information:
Title
time to need for intravenous (IV) antibiotics to treat pulmonary exacerbations
Time Frame
3 years
Title
use of other pulmonary therapies
Time Frame
3 years
Title
adherence to therapy
Time Frame
3 years
Title
patient satisfaction
Time Frame
3 years
Title
health-related quality of life
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank J Accurso, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver and The Children's Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
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Airway Secretion Clearance in Cystic Fibrosis
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