Status:
TERMINATED
Airway Secretion Clearance in Cystic Fibrosis
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Cystic Fibrosis Foundation
American Biosystems (currently Hill-Rom)
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
7+ years
Phase:
NA
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 pulmo...
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 hospitaliza...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2003
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT00839644
Start Date
December 1 1999
End Date
June 1 2003
Last Update
October 2 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Colorado Denver and The Children's Hospital
Denver, Colorado, United States, 80045