Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-01-01 @ 2:46 AM
Study NCT ID:
NCT04017312
Status:
TERMINATED
Last Update Posted:
2024-08-21
First Post:
2019-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study to Evaluate the Use of the Vest® System for Treatment of Bronchiectasis Patients in the Home Setting
Sponsor:
Hill-Rom
Organization:
Study Overview
Official Title:
Evaluation of HFCWO Using The Vest® System for Treatment of Non-Cystic Fibrosis Bronchiectasis in the Home Setting
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Data
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This a 70 patient multi-site non blinded randomized control trial evaluating the use of the Vest® System for treatment of Non-Cystic Fibrosis Bronchiectasis (NCFBE) patients in the home setting. The study will assess outcomes in subjects requiring airway clearance therapy randomized to Oscillating Positive Expiratory Pressure (OPEP) therapy as the control group and High Frequency Chest Wall Oscillation (HFCWO) therapy as the intervention group
Detailed Description:
Patients with NCFBE who require regular home airway clearance therapy will be eligible to be screened for inclusion in the study.
After enrollment, baseline data including demographics, pulmonary related medical history including acute exacerbations (pulmonary-related hospitalizations, ED visits and physician office visits) will be collected Pulmonary function tests (PFTs) (spirometry), and a six-minute walk test will be completed. Quality of Life measures and inflammatory markers and will be collected.
Patients will be randomized to HFCWO or OPEP therapy. Each device will be used within the approved product labeling. These will be the primary airway clearance devices for these patients during the 12 months of the study period.
Following enrollment in the study and completion of a baseline visit, subjects will be seen for follow-up visits.
Detailed documentation of health status and medical history will be collected during the 12-month study period and/or at each study visit to document the occurrence of acute exacerbations and to determine time to first exacerbation, number of hospitalizations and hospitalization days, number of ICU admissions and ICU days, and number of outpatient visits (Physician's office visit, Urgent Care Visits, ED visits)
At 3 months, 6 months and 12 months following the baseline visit, the following tests/procedures will be performed. At each follow-up study visit:
* Acute exacerbations that occurred during the prior 3-month period will be documented/verified
* Pulmonary function will be assessed using standard spirometry to obtain FEV1, FVC and FEV1/FVC.
* 6-minute walk test will be completed to assess respiratory status and endurance
* The QoL-B quality of life survey will be conducted
* A sputum sample will be collected. Sputum samples will be transported to a central lab to test for inflammatory markers (sputum neutrophil elastase in μg/ml).
Mean adherence to the prescribed treatment regimen will be collected and assessed using the validated Modified Self-Reported Medication-Taking Scale. Adherence data in the HFCWO arm will also be collected via the VisiView patient portal.
Adherence results will be collected at the 3-month visit, 6-month visit and 12-month visits.
Any device related adverse events which occur after initial therapy with The Vest® System or Acapella therapy will be recorded.
Any equipment related complaints which occur after initial therapy with The Vest® System or Acapella therapy will be recorded.
At the end of the 12-month study period, all subjects will be given the option of receiving HFCWO therapy for additional 6 month follow up period with outcomes data assessed at the 15-month and 18-month (from baseline visit) time points.
After enrollment, baseline data including demographics, pulmonary related medical history including acute exacerbations (pulmonary-related hospitalizations, ED visits and physician office visits) will be collected Pulmonary function tests (PFTs) (spirometry), and a six-minute walk test will be completed. Quality of Life measures and inflammatory markers and will be collected.
Patients will be randomized to HFCWO or OPEP therapy. Each device will be used within the approved product labeling. These will be the primary airway clearance devices for these patients during the 12 months of the study period.
Following enrollment in the study and completion of a baseline visit, subjects will be seen for follow-up visits.
Detailed documentation of health status and medical history will be collected during the 12-month study period and/or at each study visit to document the occurrence of acute exacerbations and to determine time to first exacerbation, number of hospitalizations and hospitalization days, number of ICU admissions and ICU days, and number of outpatient visits (Physician's office visit, Urgent Care Visits, ED visits)
At 3 months, 6 months and 12 months following the baseline visit, the following tests/procedures will be performed. At each follow-up study visit:
* Acute exacerbations that occurred during the prior 3-month period will be documented/verified
* Pulmonary function will be assessed using standard spirometry to obtain FEV1, FVC and FEV1/FVC.
* 6-minute walk test will be completed to assess respiratory status and endurance
* The QoL-B quality of life survey will be conducted
* A sputum sample will be collected. Sputum samples will be transported to a central lab to test for inflammatory markers (sputum neutrophil elastase in μg/ml).
Mean adherence to the prescribed treatment regimen will be collected and assessed using the validated Modified Self-Reported Medication-Taking Scale. Adherence data in the HFCWO arm will also be collected via the VisiView patient portal.
Adherence results will be collected at the 3-month visit, 6-month visit and 12-month visits.
Any device related adverse events which occur after initial therapy with The Vest® System or Acapella therapy will be recorded.
Any equipment related complaints which occur after initial therapy with The Vest® System or Acapella therapy will be recorded.
At the end of the 12-month study period, all subjects will be given the option of receiving HFCWO therapy for additional 6 month follow up period with outcomes data assessed at the 15-month and 18-month (from baseline visit) time points.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: