NCT00181285

Brief Summary

The objective of this study was to evaluate the use of high frequency chest wall oscillation (HFCWO) early in the treatment of adults hospitalized for acute asthma or chronic obstructive pulmonary disease (COPD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Oct 2003

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
10.3 years until next milestone

Results Posted

Study results publicly available

August 7, 2018

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

4.6 years

First QC Date

September 15, 2005

Results QC Date

May 12, 2017

Last Update Submit

August 6, 2018

Conditions

AsthmaChronic Obstructive Pulmonary Disease (COPD)Undifferentiated Asthma/COPD

Outcome Measures

Primary Outcomes (2)

  • Patient Adherence to High Frequency Chest Wall Oscillation

    Patient adherence to therapy after four treatments.

    After four treatments of 15 minutes each

  • Number of Participants Who Considered the Pneumatic Vest Convenient to Use

    The study vest was convenient to use.

    After four treatments of 15 minutes each

Study Arms (2)

Sham high frequency chest wall oscillation

SHAM COMPARATOR

Sham high frequency chest wall oscillation

Device: High Frequency Chest Wall Oscillator

Active high frequency chest wall oscillation

ACTIVE COMPARATOR

Active high frequency chest wall oscillation

Device: High Frequency Chest Wall Oscillator

Interventions

High Frequency Chest Wall OscillatorDEVICE

High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax

Active high frequency chest wall oscillationSham high frequency chest wall oscillation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years and older
  • Admission to the inpatient medical service
  • Physician-diagnosed asthma or asthma/COPD or COPD exacerbation.
  • Evidence of airflow obstruction on spirometry

You may not qualify if:

  • More than 24 hours since admission to the inpatient medical service
  • Admission to an intensive care unit
  • Hospital discharge planned within the next 24 hours
  • Other chronic respiratory disease (e.g., sarcoidosis, idiopathic pulmonary fibrosis)
  • Chest wall abnormalities (e.g., severe kyphoscoliosis) that precludes using the vest
  • Chest wall or abdominal trauma/surgery in the past 6 weeks that precludes using the vest
  • Physician declines to provide consent
  • Patient unable (e.g., history of cognitive impairment, unable to understand English) or declines to provide consent
  • Previous participant in this study
  • Corticosteroid therapy (prednisone \>0 mg/d equivalent) for \>1 week prior to admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mercy Hospital and Medical Center

Chicago, Illinois, 60616, United States

Location

Related Publications (1)

  • Mahajan AK, Diette GB, Hatipoglu U, Bilderback A, Ridge A, Harris VW, Dalapathi V, Badlani S, Lewis S, Charbeneau JT, Naureckas ET, Krishnan JA. High frequency chest wall oscillation for asthma and chronic obstructive pulmonary disease exacerbations: a randomized sham-controlled clinical trial. Respir Res. 2011 Sep 10;12(1):120. doi: 10.1186/1465-9921-12-120.

    PMID: 21906390DERIVED

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Jerry A. Krishnan
Organization
University of Illinois at Chicago
jakris@uic.edu
312-413-0637

Study Officials

  • Jerry A Krishnan, MD, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 16, 2005

Study Start

October 1, 2003

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

August 8, 2018

Results First Posted

August 7, 2018

Record last verified: 2018-08

Locations

US(1)