Airway Secretion Clearance in Cystic Fibrosis

Not Applicable

Terminated

• Conditions: Cystic Fibrosis
• Interventions: Device: Oscillatory Positive Expiratory Pressure; Device: High frequency chest wall oscillation

• Registration Number: NCT00839644
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 1999-12
• Primary Completion: 2002-12
• Study Completion: 2003-06
• Study First Submitted: 2009-02-05
• Study First Submitted QC: 2009-02-06
• Study First Posted: 2009-02-09
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-01
• Last Update Posted: 2012-10-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 166

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Oscillatory Positive Expiratory Pressure	-
1	High frequency chest wall oscillation	-

Primary Outcome Measures

Name	Time	Method
rate of forced expiratory volume in 1 second (FEV1) decline	3 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Colorado Denver and The Children's Hospital; 🇺🇸 Denver, Colorado, United States