Airway Clearance for Prevention of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to show that one form of mechanical airway clearance techniques, High Frequency Chest Wall Oscillation (HFCWO)using a pneumatic vest, will diminish exacerbations of COPD which will improve respiratory health status.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Effectiveness Of High Frequency Chest Wall Oscillation (HFCWO) In A Bronchiectasis Population

NCT04271969

Bronchiectasis

COMPLETED

Effect of HFCWO Vests on Spirometry Measurements

NCT03628456

Cystic Fibrosis Bronchiectasis

COMPLETED NA

High Frequency Chest Wall Oscillation in Chronic Obstructive Pulmonary Disease (COPD)

NCT00863616

Chronic Obstructive Pulmonary Disease

COMPLETED NA

Chest Wall Oscillation for Asthma and COPD Exacerbations Trial (COAT)

NCT00181285

Asthma Chronic Obstructive Pulmonary Disease (COPD) Undifferentiated Asthma/COPD

COMPLETED NA

The Effect of Airway and Chest Wall Oscillation on Respiratory Functions in COPD Patients in Acute Exacerbation

NCT06274957

COPD Exacerbation Acute

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Approximately 60 to 70% of people with COPD have chronic cough and phlegm, the cardinal symptoms of chronic bronchitis or chronic mucus hypersecretion (CMH). Once thought to be a relatively benign condition, recent evidence shows that CMH in patients with established COPD is associated with greater decline in lung function, more frequent respiratory infections, more frequent exacerbations and increased mortality.Using mechanical airway clearance techniques (The Vest) will diminish exacerbations of COPD which will improve respiratory health status.

Comparison: Patients randomly assigned to the vest will have fewer exacerbations of COPD,better quality of life and less health care use compared to patients assigned to a sham vest.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD Chronic Bronchitis Emphysema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active

Pneumatic Compression Device used twice daily for 20 minutes each time for 12 weeks

Group Type EXPERIMENTAL

pneumatic vest

Intervention Type DEVICE

Sham

Device looked and sounded like a pneumatic compression device, but was not inflating nor deflating.

Group Type PLACEBO_COMPARATOR

placebo pneumatic vest

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pneumatic vest

Intervention Type DEVICE

placebo pneumatic vest

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Physician Diagnosis of COPD,chronic bronchitis and/or emphysema
* Forced Expiratory Volume in 1 second (FEV1)/ Forced Vital Capacity (FVC) \< or = 70%
* FEV1 \< or = 65%
* Current or former smoker \> or = 20 pack years
* History of 1 or more COPD exacerbations in past 6 months necessitation hospitalization, Emergency Department (ED) visit, antibiotic or steroid prescription

Exclusion Criteria

* Other lung diseases
* Co-morbid illnesses such as cancer, liver disease, cardiomyopathy
* Recent chest wall or abdominal trauma or surgery that would preclude using the vest

Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No