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Evaluation of an Airway Clearance System

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ClinicalTrials.gov Identifier: NCT03091062
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Hill-Rom

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

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Device: Vest® Airway Clearance System Device: Monarch™ System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effectiveness of the Monarch™ Airway Clearance System as Determined by Mucus Production
Actual Study Start Date : March 30, 2017
Actual Primary Completion Date : February 2, 2018
Actual Study Completion Date : February 2, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study Group
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
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.

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




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091062


Locations
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Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Sponsors and Collaborators
Hill-Rom

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Responsible Party: Hill-Rom
ClinicalTrials.gov Identifier: NCT03091062     History of Changes
Other Study ID Numbers: FLUI-2016-182
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases