Airway Secretion Clearance in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Airway Secretion Clearance in Cystic Fibrosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00839644
• Other study ID #: 06-0609
• Secondary ID: ACCURS98A0
• Status: Terminated
• Phase: N/A
• First received: February 5, 2009
• Last updated: October 1, 2012
• Start date: December 1999
• Est. completion date: June 2003

Study information

• Verified date: October 2012
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 166
• Est. completion date: June 2003
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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.
• 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:
• 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.

Locations

Country	Name	City	State
United States	University of Colorado Denver and The Children's Hospital	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	American Biosystems (currently Hill-Rom), Cystic Fibrosis Foundation Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of forced expiratory volume in 1 second (FEV1) decline		3 years	No
Secondary	time to need for intravenous (IV) antibiotics to treat pulmonary exacerbations		3 years	No
Secondary	use of other pulmonary therapies		3 years	No
Secondary	adherence to therapy		3 years	No
Secondary	patient satisfaction		3 years	No
Secondary	health-related quality of life		3 years	No