Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181285
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2005-09-15
Brief Title:
Chest Wall Oscillation for Asthma and COPD Exacerbations Trial COAT
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Chest Wall Oscillation for Asthma and COPD Exacerbations Trial COAT
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 used60 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
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 used60 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None