Evaluation of an Airway Clearance System

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03091062
• Other study ID #: FLUI-2016-182
• Status: Completed
• Phase: N/A
• First received: February 14, 2017
• Last updated: April 16, 2018
• Start date: March 30, 2017
• Est. completion date: February 2, 2018

Study information

• Verified date: April 2018
• Source: Hill-Rom
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 2, 2018
• Est. primary completion date: February 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cystic Fibrosis

Intervention

Device:
• Vest® 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.
• Monarch™ System
Generates airflow at frequencies similar to those provided by HFCWO and also provides direct percussive therapy.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Edegem

Sponsors (1)

Lead Sponsor	Collaborator
Hill-Rom

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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