Evaluation of an Airway Clearance System

Study Overview
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Brief Summary
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The aim of this study is to assess the effectiveness of an Airway Clearance System.

Detailed Description
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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.

Official Title
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Evaluation of the Effectiveness of the Monarch™ Airway Clearance System as Determined by Mucus Production

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Device: Vest® Airway Clearance System
* Device: Monarch™ System


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>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. | Device: Vest® Airway Clearance System<br>* 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.<br>Device: Monarch™ System<br>* Generates airflow at frequencies similar to those provided by HFCWO and also provides direct percussive therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion, an average of 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion, an average of 2 months | 
| 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). | Through study completion, an average of 2 months | 
| 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). | Through study completion, an average of 2 months | 
| 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). | Through study completion, an average of 2 months | 
| 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). | Through study completion, an average of 2 months | 
| 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). | Through study completion, an average of 2 months |