Evaluation of an Airway Clearance System

NCT03091062 | Completed

• 1 other identifier: FLUI-2016-182
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Sputum Volume

  Through study completion, an average of 2 months

• Functional Respiratory Imaging

  Through study completion, an average of 2 months

• Brody Scores (Scoring of CT Scans)

  Through study completion, an average of 2 months

• Lung Clearance Index

  Through study completion, an average of 2 months

• Subjective satisfaction surveys

  Through study completion, an average of 2 months

Study Arms (1)

Study Group

EXPERIMENTAL

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; Device: Monarch™ System

Interventions

Vest® Airway Clearance System DEVICE

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.

Study Group

Monarch™ System DEVICE

Generates airflow at frequencies similar to those provided by HFCWO and also provides direct percussive therapy.

Study Group

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hill-Rom: lead

Study Sites (1)

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: March 27, 2017
• Study Start: March 30, 2017
• Primary Completion: February 2, 2018
• Study Completion: February 2, 2018
• Last Updated: April 17, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)