Back to resultsEvaluation of an Airway Clearance System
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Vest® Airway Clearance System
Monarch™ System
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis
Eligibility Criteria
Inclusion Criteria:
- Documented diagnosis of Cystic Fibrosis (CF) (by sweat test and/or genetics)
- Age ≥ 15 years
- Ability to expectorate sputum daily - determined by treating physician
- Patient must be on a stable regimen of CF medication for 4 weeks prior to Visit 1
- Patient who requires regular home airway clearance therapy
Exclusion Criteria:
- Forced Expiratory Volume in 1 Second (FEV1) < 30 % predicted or > 90 % predicted
- Anticipated requirement for hospitalization within the next three weeks
- History of pneumothorax within the past 6 months prior Visit 1
- History of haemoptysis requiring embolization within the past 12 months prior to Visit 1
- Inability to perform Monarch™ and/or Vest® System therapy as directed
- Unable or unwilling to complete study visits or provide follow-up data as required per the study protocol
- Has taken Intravenous (IV) antibiotics within the past 4 weeks prior to Visit 1
- Has ongoing exacerbation or Allergic bronchopulmonary aspergillosis (ABPA)
- Pregnant or lactating female
- Has a pacemaker or implantable cardioverter defribillator (ICD)
Sites / Locations
- Universitair Ziekenhuis Antwerpen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Group
Arm Description
Study subjects will serve as their own control and all will receive treatment with two different Airway Clearance Systems- the Vest® Airway Clearance System and the Monarch™ System. Subjects will be randomized to which treatment is received first.
Outcomes
Primary Outcome Measures
Wet Weight of Sputum Produced
Assessment of the wet weight of total sputum that is produced as a result of each of two therapy sessions. The total wet weight includes the wet weight of sputum collected each 30-minute therapy session + the wet weight of sputum collected during a 1-hour collection period following each therapy.
Secondary Outcome Measures
Sputum Volume
Assessment of the total volume of sputum that is produced as a result of each of two therapy sessions. The total volume includes the volume of sputum collected each 30-minute therapy session + the volume of sputum collected during a 1-hour collection period following each therapy.
Functional Respiratory Imaging
Functional Respiratory Imaging will be completed utilizing CT scans. The CT scans are to be completed before airway clearance therapy on each day and after the one-hour sputum collection following the airway clearance therapy (a minimum of one hour following completion of the airway clearance therapy).
Brody Scores (Scoring of CT Scans)
Brody Scores will be completed utilizing CT scans. The CT scans are to be completed before airway clearance therapy on each day and after the one-hour sputum collection following the airway clearance therapy (a minimum of one hour following completion of the airway clearance therapy).
Lung Clearance Index
Measurement of how much ventilation is required to completely clear the full residual capacity using the Inert Gas Multi-Breath Washout method completed pre- and post-therapy -- before the airway clearance therapy on each day and after the one-hour sputum collection following the airway clearance therapy (a minimum of one hour following completion of the airway clearance therapy).
Subjective satisfaction surveys
Patient satisfaction with therapy will be assessed post therapy. (survey will be completed a minimum of one hour following completion of the airway clearance therapy).
Spirometry
Forced expiratory spirometry maneuvers will be completed before and after therapy. -- before the airway clearance therapy on each day and after the one-hour sputum collection following the airway clearance therapy (a minimum of one hour following completion of the airway clearance therapy).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03091062
Brief Title
Evaluation of an Airway Clearance System
Official Title
Evaluation of the Effectiveness of the Monarch™ Airway Clearance System as Determined by Mucus Production
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
February 2, 2018 (Actual)
Study Completion Date
February 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hill-Rom
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to assess the effectiveness of an Airway Clearance System.
Detailed Description
The study will compare the effectiveness of The Monarch™ System and The Vest® Airway Clearance System. All subjects will receive treatment with both systems and endpoints will be compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Arm Description
Study subjects will serve as their own control and all will receive treatment with two different Airway Clearance Systems- the Vest® Airway Clearance System and the Monarch™ System. Subjects will be randomized to which treatment is received first.
Intervention Type
Device
Intervention Name(s)
Vest® Airway Clearance System
Intervention Description
High frequency chest wall oscillation (HFCWO) therapy is commonly prescribed to provide routine airway clearance in patients with a need for regular airway clearance therapy. HFCWO generates high velocity expiratory airflow that is thought to mobilize secretions by the sheer force created.
Intervention Type
Device
Intervention Name(s)
Monarch™ System
Intervention Description
Generates airflow at frequencies similar to those provided by HFCWO and also provides direct percussive therapy.
Primary Outcome Measure Information:
Title
Wet Weight of Sputum Produced
Description
Assessment of the wet weight of total sputum that is produced as a result of each of two therapy sessions. The total wet weight includes the wet weight of sputum collected each 30-minute therapy session + the wet weight of sputum collected during a 1-hour collection period following each therapy.
Time Frame
Through study completion, an average of 2 months
Secondary Outcome Measure Information:
Title
Sputum Volume
Description
Assessment of the total volume of sputum that is produced as a result of each of two therapy sessions. The total volume includes the volume of sputum collected each 30-minute therapy session + the volume of sputum collected during a 1-hour collection period following each therapy.
Time Frame
Through study completion, an average of 2 months
Title
Functional Respiratory Imaging
Description
Functional Respiratory Imaging will be completed utilizing CT scans. The CT scans are to be completed before airway clearance therapy on each day and after the one-hour sputum collection following the airway clearance therapy (a minimum of one hour following completion of the airway clearance therapy).
Time Frame
Through study completion, an average of 2 months
Title
Brody Scores (Scoring of CT Scans)
Description
Brody Scores will be completed utilizing CT scans. The CT scans are to be completed before airway clearance therapy on each day and after the one-hour sputum collection following the airway clearance therapy (a minimum of one hour following completion of the airway clearance therapy).
Time Frame
Through study completion, an average of 2 months
Title
Lung Clearance Index
Description
Measurement of how much ventilation is required to completely clear the full residual capacity using the Inert Gas Multi-Breath Washout method completed pre- and post-therapy -- before the airway clearance therapy on each day and after the one-hour sputum collection following the airway clearance therapy (a minimum of one hour following completion of the airway clearance therapy).
Time Frame
Through study completion, an average of 2 months
Title
Subjective satisfaction surveys
Description
Patient satisfaction with therapy will be assessed post therapy. (survey will be completed a minimum of one hour following completion of the airway clearance therapy).
Time Frame
Through study completion, an average of 2 months
Title
Spirometry
Description
Forced expiratory spirometry maneuvers will be completed before and after therapy. -- before the airway clearance therapy on each day and after the one-hour sputum collection following the airway clearance therapy (a minimum of one hour following completion of the airway clearance therapy).
Time Frame
Through study completion, an average of 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented diagnosis of Cystic Fibrosis (CF) (by sweat test and/or genetics)
Age ≥ 15 years
Ability to expectorate sputum daily - determined by treating physician
Patient must be on a stable regimen of CF medication for 4 weeks prior to Visit 1
Patient who requires regular home airway clearance therapy
Exclusion Criteria:
Forced Expiratory Volume in 1 Second (FEV1) < 30 % predicted or > 90 % predicted
Anticipated requirement for hospitalization within the next three weeks
History of pneumothorax within the past 6 months prior Visit 1
History of haemoptysis requiring embolization within the past 12 months prior to Visit 1
Inability to perform Monarch™ and/or Vest® System therapy as directed
Unable or unwilling to complete study visits or provide follow-up data as required per the study protocol
Has taken Intravenous (IV) antibiotics within the past 4 weeks prior to Visit 1
Has ongoing exacerbation or Allergic bronchopulmonary aspergillosis (ABPA)
Pregnant or lactating female
Has a pacemaker or implantable cardioverter defribillator (ICD)
Facility Information:
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of an Airway Clearance System
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