Airway Secretion Clearance in Cystic Fibrosis | NCT00839644

Studies
Airway Secretion Clearance in Cystic Fibrosis

NCT00839644

Sponsor

University of Colorado, Denver

Status

Terminated

Last Update Posted

Oct 2, 2012Estimated

Enrollment

166Actual

Phase

Not Applicable

Conditions

Cystic Fibrosis

Interventions

High frequency chest wall oscillation
Oscillatory Positive Expiratory Pressure
PD&P: Postural drainage and percussion

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ACCURS98A0	Other Grant/Funding Number	Cystic Fibrosis Foundation

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

High dropout, problems recruiting, and smaller than expected decline in FEV1.

Expanded Access Info

Start Date

Dec 1999

Primary Completion Date

Dec 2002Actual

Completion Date

Jun 2003Actual

First Submitted Date

Feb 5, 2009

First Submission Date that Met QC Criteria

Feb 6, 2009

First Posted Date

Feb 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2012

Last Update Posted Date

Oct 2, 2012Estimated

Name	Class
Cystic Fibrosis Foundation	OTHER
American Biosystems (currently Hill-Rom)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

166Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
2	Active Comparator	Device: Oscillatory Positive Expiratory Pressure
3	Active Comparator	Other: PD&P: Postural drainage and percussion
1	Active Comparator	Device: High frequency chest wall oscillation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High frequency chest wall oscillation	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
rate of forced expiratory volume in 1 second (FEV1) decline		3 years

Secondary Outcomes

Measure	Description	Time Frame
time to need for intravenous (IV) antibiotics to treat pulmonary exacerbations		3 years
use of other pulmonary therapies		3 years
adherence to therapy

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frank J Accurso, MD	University of Colorado, Denver	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Denver and The Children's Hospital		Denver	Colorado	80045	United States

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis
D055118	Medication Adherence
D010352	Patient Dropouts

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D035641	Chest Wall Oscillation
C000708228	2-cyclohexylidenhydrazo-4-phenyl-thiazole

Ancestor Terms

ID	Term
D012138	Respiratory Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided