NCT00863616

Brief Summary

Patients with Chronic obstructive pulmonary disease (COPD) tend to have cough, excess mucus production and breathlessness as cardinal features. The excess mucus production often leads to frequent infections, exacerbations and poor quality of life. Mucociliary clearance may have an impact on improving symptoms, exercise tolerance, quality of life and reduce exacerbations. High frequency chest wall oscillation(HFCWO) devices use percussion to the chest wall delivered from a pump through a close fitting inflatable vest. This technique has been shown to enhance mucus clearance in patients with cystic fibrosis and Bronchiectasis. This pilot study was designed to explore the feasibility, tolerance and effectiveness of the HFCWO in patients with advanced COPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Aug 2006

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

August 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2009

Completed
Last Updated

March 18, 2009

Status Verified

March 1, 2009

Enrollment Period

1.2 years

First QC Date

March 17, 2009

Last Update Submit

March 17, 2009

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDMucus hypersecretionHRQLESWTHFCWO

Outcome Measures

Primary Outcomes (1)

  • Health related quality of life (St George's Respiratory Questionnaire)

    3 months

Secondary Outcomes (1)

  • Exercise tolerance (Endurance Shuttle Walk Time achieved)

    3 months

Study Arms (2)

HFCWO

EXPERIMENTAL

HFCWO twice a day delivered by SmartVest device at 13Hz FOR 20min x2. Duration 4 weeks in each phase with a 2week washout.

Device: HFCWO - SmartVest

Placebo/Control

NO INTERVENTION

Self-administered breathing exercises

Interventions

HFCWO - SmartVestDEVICE

SmartVest with vest administered for 20min at 11-13Hz

Also known as: SmartVest
HFCWO

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD; patients defined by a history of cough, breathlessness and/ mucus/sputum production with lung function showing FEV1/FVC \<70% and FEV1\<80% predicted and \< 20% reversibility from baseline on administration of nebulised b2-agonist (Salbutamol 5mg)
  • Age 40-85 years
  • Mucus hypersecretion ( \> 25 ml/72 h collection)

You may not qualify if:

  • Chest wall deformity (i.e., kyphoscoliosis, Rib fractures)
  • Severe osteoporosis
  • Haemoptysis within the last 3 months
  • Thoracic or abdominal surgery within 3 months
  • Respiratory failure on non-invasive ventilator therapy
  • Tracheostomy or neck deformities
  • Neuro-muscular dysfunction or disability (i.e., Paralysis due to cerebrovascular disease) which may make it impossible to use the device safely
  • Congestive heart failure (decompensated)
  • Any other mucolytic therapy
  • Significant hiatus hernia or gastro-esophageal reflux disease
  • Recent myocardial infarction or unstable angina

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East & North Herts NHS Trust

Stevenage, Herts, SG1 4AB, United Kingdom

Location

Related Publications (1)

  • Chakravorty I, Chahal K, Austin G. A pilot study of the impact of high-frequency chest wall oscillation in chronic obstructive pulmonary disease patients with mucus hypersecretion. Int J Chron Obstruct Pulmon Dis. 2011;6:693-9. doi: 10.2147/COPD.S22896. Epub 2011 Dec 14.

    PMID: 22259246DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Indranil Chakravorty, PhD, MRCP

    East & North Herts NHS Trust, Stevenage, Herts, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 17, 2009

First Posted

March 18, 2009

Study Start

August 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

March 18, 2009

Record last verified: 2009-03

Locations

GB(1)