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
  Purpose

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 Intervention
Cystic Fibrosis
Device: High frequency chest wall oscillation
Device: Oscillatory Positive Expiratory Pressure
Other: PD&P: Postural drainage and percussion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Airway Secretion Clearance in Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • rate of forced expiratory volume in 1 second (FEV1) decline [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 166
Study Start Date: December 1999
Study Completion Date: June 2003
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Vest

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.

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00839644

Locations
United States, Colorado
University of Colorado Denver and The Children's Hospital
Denver, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Cystic Fibrosis Foundation
American Biosystems (currently Hill-Rom)
Investigators
Principal Investigator: Frank J Accurso, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00839644     History of Changes
Other Study ID Numbers: 06-0609, ACCURS98A0
Study First Received: February 5, 2009
Last Updated: October 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
cystic fibrosis
Chest Wall Oscillation
drainage, postural
Medication Adherence
patient dropouts

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014