Asthma, Chronic Obstructive Pulmonary Disease (COPD), Undifferentiated Asthma/COPD
Conditions
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).
Detailed description
Acute asthma and chronic obstructive pulmonary disease (COPD) are exceedingly common, which together account for nearly 1 million hospitalizations each year in the United States alone. Beta agonists, anticholinergics, and corticosteroids delivered in aerosolized forms (via respiratory inhalers or nebulization) are recommended in the treatment of acute asthma and COPD. These medications rely on deposition into distal airspaces to suppress airway inflammation or promote bronchodilation. Unfortunately, excessive mucous production and impaired airway mucociliary clearance can lead to airway plugging, and thereby reduce the deposition of and response to aerosolized medications. These considerations highlight the need for therapies that clear airways of mucus in the acute management of asthma and COPD. High frequency chest wall oscillation (HFCWO) creates high velocity, low amplitude oscillatory airflows when applied through a pneumatic vest worn over the thorax, and is used for airway mucus clearance in patients with cystic fibrosis, bronchiectasis, and neuromuscular disorders. This was a randomized, multi-center, double-masked phase II clinical trial of active or sham treatment initiated within 24 hours of hospital admission for acute asthma or COPD at four academic medical centers. Patients received active or sham treatment for 15 minutes three times a day for four treatments. Medical management was standardized across groups. The primary outcomes were patient adherence to therapy after four treatments (minutes used/60 minutes prescribed) and satisfaction. Secondary outcomes included change in Borg dyspnea score (≥ 1 unit indicates a clinically significant change), spontaneously expectorated sputum volume, and forced expired volume in 1 second.
Interventions
High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax
Sponsors
Hill-Rom
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Adherence to High Frequency Chest Wall Oscillation | After four treatments of 15 minutes each | Patient adherence to therapy after four treatments. |
| Number of Participants Who Considered the Pneumatic Vest Convenient to Use | After four treatments of 15 minutes each | The study vest was convenient to use. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sham High Frequency Chest Wall Oscillation Sham high frequency chest wall oscillation
High Frequency Chest Wall Oscillator: High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax | 27 |
| Active High Frequency Chest Wall Oscillation High frequency chest wall oscillation
High Frequency Chest Wall Oscillator: High velocity, low amplitude oscillatory airflow applied through a pneumatic vest worn over the thorax | 25 |
| Total | 52 |
Baseline characteristics
| Characteristic | Sham High Frequency Chest Wall Oscillation | Active High Frequency Chest Wall Oscillation | Total |
|---|---|---|---|
| Age, Continuous | 50.4 years | 46.5 years | 48.5 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | — | — | 0 Participants |
| Sex: Female, Male Male | — | — | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 25 |
| serious Total, serious adverse events | 0 / 27 | 0 / 25 |
Outcome results
Primary
Number of Participants Who Considered the Pneumatic Vest Convenient to Use
The study vest was convenient to use.
Time frame: After four treatments of 15 minutes each
Population: 1 participant in the Sham group and 1 participant in the Active group had missing data for the question regarding the convenience of the pneumatic vest, therefore these participants were not included in the number analyzed for the outcome measure data table below.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sham High Frequency Chest Wall Oscillation | Number of Participants Who Considered the Pneumatic Vest Convenient to Use | 24 Participants |
| Active High Frequency Chest Wall Oscillation | Number of Participants Who Considered the Pneumatic Vest Convenient to Use | 19 Participants |
Primary
Patient Adherence to High Frequency Chest Wall Oscillation
Patient adherence to therapy after four treatments.
Time frame: After four treatments of 15 minutes each
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham High Frequency Chest Wall Oscillation | Patient Adherence to High Frequency Chest Wall Oscillation | 93 Percent of 60 minutes prescribed | Standard Deviation 18.7 |
| Active High Frequency Chest Wall Oscillation | Patient Adherence to High Frequency Chest Wall Oscillation | 91 Percent of 60 minutes prescribed | Standard Deviation 21.1 |