Cystic FibrosisNCT03091062
Evaluation of an Airway Clearance System
A study testing Vest® Airway Clearance System and Monarch™ System in people with Cystic Fibrosis, run by Hill-Rom at 1 site in Belgium.
Trial summary
The aim of this study is to assess the effectiveness of an Airway Clearance System. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Vest® Airway Clearance System and Monarch™ System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Mar 2017to 2 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of the Monarch™ Airway Clearance System as Determined by Mucus Production
The aim of this study is to assess the effectiveness of an Airway Clearance System.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Vest® Airway Clearance System, Monarch™ System
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vest® Airway Clearance SystemDevice
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™ SystemDevice
Generates airflow at frequencies similar to those provided by HFCWO and also provides direct percussive therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Vest® Airway Clearance System; Device: Monarch™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 2 months
Secondary outcomes (6)
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.
Measured: Through study completion, an average of 2 months
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).
Measured: Through study completion, an average of 2 months
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).
Measured: Through study completion, an average of 2 months
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).
Measured: Through study completion, an average of 2 months
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).
Measured: Through study completion, an average of 2 months
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).
Measured: Through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start30 Mar 2017
- Primary completion2 Feb 2018
- Study completion2 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hill-Rom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091062
- Sponsor's protocol ID
- FLUI-2016-182
- Status last verified
- Apr 2018
- First submitted
- 14 Feb 2017
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Monarch™ Airway Clearance System as Determined by Mucus Production
- ClinicalTrials.gov ID
- NCT03091062
- Acronym / sponsor ID
- FLUI-2016-182
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Hill-RomIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 2 Feb 2018 (actual)
- Study completion
- 2 Feb 2018 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the effectiveness of an Airway Clearance System.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: Vest® Airway Clearance System, Device: Monarch™ SystemStudy 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vest® Airway Clearance SystemHigh 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 | Study Group |
| Monarch™ SystemGenerates airflow at frequencies similar to those provided by HFCWO and also provides direct percussive therapy. | Device | Study Group |
Primary outcome
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.
6 secondary outcomes
Sputum Volume
Time frame: Through study completion, an average of 2 months
Functional Respiratory Imaging
Time frame: Through study completion, an average of 2 months
Brody Scores (Scoring of CT Scans)
Time frame: Through study completion, an average of 2 months
Lung Clearance Index
Time frame: Through study completion, an average of 2 months
Subjective satisfaction surveys
Time frame: Through study completion, an average of 2 months
Spirometry
Time frame: Through study completion, an average of 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vest® Airway Clearance System and Monarch™ System in people with Cystic Fibrosis, run by Hill-Rom at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wet Weight of Sputum Produced (time frame: Through study completion, an average of 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.