Cystic Fibrosis
Conditions
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.
Interventions
DEVICEVest® Airway Clearance System
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.
DEVICEMonarch™ System
Generates airflow at frequencies similar to those provided by HFCWO and also provides direct percussive therapy.
Sponsors
Hill-Rom
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wet Weight of Sputum Produced | Through study completion, an average of 2 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional Respiratory Imaging | Through study completion, an average of 2 months | 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) | Through study completion, an average of 2 months | 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). |
| Sputum Volume | Through study completion, an average of 2 months | 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. |
| Subjective satisfaction surveys | Through study completion, an average of 2 months | 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 | Through study completion, an average of 2 months | 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). |
| Lung Clearance Index | Through study completion, an average of 2 months | 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). |
Countries
Belgium
Outcome results
None listed