Evaluation of an Airway Clearance System

Hill-Rom

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Device: Monarch™ System; Device: Vest® Airway Clearance System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03091062

FLUI-2016-182

Details and patient eligibility

About

The aim of this study is to assess the effectiveness of an Airway Clearance System.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Study Group

Experimental group

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.

Treatment:

Device: Vest® Airway Clearance System

Device: Monarch™ System