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Airway Secretion Clearance in Cystic Fibrosis

This study has been terminated.
(High dropout, problems recruiting, and smaller than expected decline in FEV1.)
Sponsor:
Collaborators:
Cystic Fibrosis Foundation
American Biosystems (currently Hill-Rom)
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00839644
First received: February 5, 2009
Last updated: October 1, 2012
Last verified: October 2012

February 5, 2009
October 1, 2012
December 1999
December 2002   (final data collection date for primary outcome measure)
rate of forced expiratory volume in 1 second (FEV1) decline [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00839644 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Airway Secretion Clearance in Cystic Fibrosis
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 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cystic Fibrosis
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
166
June 2003
December 2002   (final data collection date for primary outcome measure)

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.
Both
7 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00839644
06-0609, ACCURS98A0
Yes
University of Colorado, Denver
University of Colorado, Denver
  • Cystic Fibrosis Foundation
  • American Biosystems (currently Hill-Rom)
Principal Investigator: Frank J Accurso, MD University of Colorado, Denver
University of Colorado, Denver
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP