NCT00839644

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2009

Completed
Last Updated

October 2, 2012

Status Verified

October 1, 2012

Enrollment Period

3 years

First QC Date

February 5, 2009

Last Update Submit

October 1, 2012

Conditions

Cystic Fibrosis

Keywords

cystic fibrosisChest Wall Oscillationdrainage, posturalMedication Adherencepatient dropouts

Outcome Measures

Primary Outcomes (1)

  • rate of forced expiratory volume in 1 second (FEV1) decline

    3 years

Secondary Outcomes (5)

  • 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

Study Arms (3)

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

High frequency chest wall oscillationDEVICE

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.

Also known as: Vest
1
Oscillatory Positive Expiratory PressureDEVICE

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

Also known as: Flutter Device (Scandipharm, Birmingham, AL)
2
PD&P: Postural drainage and percussionOTHER

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.

Also known as: CPT
3

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver and The Children's Hospital

Denver, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Cystic FibrosisMedication AdherencePatient Dropouts

Interventions

Chest Wall Oscillation2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeutics

Study Officials

  • Frank J Accurso, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2009

First Posted

February 9, 2009

Study Start

December 1, 1999

Primary Completion

December 1, 2002

Study Completion

June 1, 2003

Last Updated

October 2, 2012

Record last verified: 2012-10

Locations

US(1)