Airway Secretion Clearance in Cystic Fibrosis

NCT ID: NCT00839644

Last Updated: 2012-10-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-12-31
• Study Completion Date: 2003-06-30

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2

Group Type: ACTIVE_COMPARATOR

Oscillatory Positive Expiratory Pressure

Intervention Type: DEVICE

Therapy was prescribed twice daily for 20 minute sessions and included airway vibration, oscillating PEP, and forced expiratory technique (FET) with coughing.

3

Group Type: ACTIVE_COMPARATOR

PD&P: Postural drainage and percussion

Intervention Type: OTHER

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.

1

Group Type: ACTIVE_COMPARATOR

High frequency chest wall oscillation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Vest; Flutter Device (Scandipharm, Birmingham, AL); CPT

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.

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cystic Fibrosis Foundation

OTHER

Sponsor Role: collaborator

American Biosystems (currently Hill-Rom)

UNKNOWN

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank J Accurso, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Denver and The Children's Hospital

Denver, Colorado, United States

Countries

United States

Other Identifiers

ACCURS98A0

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

06-0609

Identifier Type: -

Identifier Source: org_study_id