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Completed

NCT Number: NCT03091062

Evaluation of an Airway Clearance System

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

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Key information

Conditions

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

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Monarch™ System

Device

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

Primary outcomes

  1. Wet Weight of Sputum Produced

    Time frame: 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 outcomes

  1. Sputum Volume

    Time frame: 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.

  2. Functional Respiratory Imaging

    Time frame: 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).

  3. Brody Scores (Scoring of CT Scans)

    Time frame: 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).

  4. Lung Clearance Index

    Time frame: 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).

  5. Subjective satisfaction surveys

    Time frame: 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).

  6. Spirometry

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Hill-Rom

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 27, 2017
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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