Cystic FibrosisHFCWONCT03645473
Evaluation of Device Settings for Airway Clearance Using The Monarch Airway Clearance System
A study testing Monarch Airway Clearance System in people with Cystic Fibrosis, run by Hill-Rom.
Trial summary
The study will be an open label laboratory study with all subjects receiving HFCWO with The Monarch® System Objective: Assess device settings and to identify frequency/pressure (intensity) combinations that produce high airflow and oscillating volume Methodology: Subjects will receive HFCWO using The Monarch® 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?
- Monarch Airway Clearance System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 24 Jan 2019to 12 Apr 2019
- 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 CF (by sweat test and/or genetics
- Age > 15 years
- Require regular home airway clearance therapy
- Current user of The Monarch® System with a minimum of 4 weeks experience with the device
- Signed informed consent. If patient is a minor, parents/guardians must give written informed consent and patient must give written assent
- Patient must be on a stable regimen of CF medication
Who cannot join
- History of pneumothorax within the past 6 months prior to study visit
- History of hemoptysis requiring embolization within the past 12 months prior to study visit or hemoptysis of > 100 ml within a 24-hour period within the past 30 days
- History of lobectomy
- Recent chest surgery or chest trauma
- Inability to perform The Monarch® System therapy as directed
- Pregnant or lactating female
- Have a pacemaker or implantable cardioverter defibrillator (ICD)
- Requirement for oral or IV antibiotics that are not part of the subject's usual course of treatment within the past 14 days prior to screening
About this study
The study will be an open label laboratory study with all subjects receiving HFCWO with The Monarch® System
Objective:
Assess device settings and to identify frequency/pressure (intensity) combinations that produce high airflow and oscillating volume
Methodology:
Subjects will receive HFCWO using The Monarch® System at multiple frequency / intensity combinations on a single visit day. Frequency / intensity combinations will be evaluated to determine which settings produce highest airflow and highest oscillating volume.
Read the detailed description
The study will be an open-label, laboratory study. All enrolled subjects will receive HFCWO therapy with the Monarch® system. The study will be conducted at one (1) site in the US.
The study will evaluate oscillating airflow and oscillating volume induced during therapy with the Monarch® system. Subjects will also rate the comfort of the therapy. Patients with cystic fibrosis (CF) who meet all of the inclusion criteria and none of the exclusion criteria will be enrolled in the study.
Therapy with the Monarch® system will be delivered using multiple frequency/intensity combination settings. The order of settings will be randomized for each study subject. During therapy oscillating flow and volume measurements will be obtained for each frequency/intensity combination. Following each frequency/intensity combination, subjects will respond to a subjective assessment of the comfort of the therapy by rating the comfort on a visual analogue scale (VAS).
- Conditions
- Cystic Fibrosis
- Being tested
- Monarch Airway Clearance 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.
Monarch Airway Clearance SystemDevice
HFCWO Airway Clearance Device
| Study group | Role | What they receive |
|---|---|---|
| Monarch device settings assessment group | Experimental | Patients with cystic fibrosis who have experience with the Monarch Airway Clearance System will be enrolled in the study.
The duration of subject participation is approximately 4 - 6 hours during 1 study visit. Each subject will receive therapy with The Monarch® System at multiple frequency and intensity combinations as defined in the Study procedures. Receives: Device: Monarch Airway Clearance System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oscillating expiratory airflow measurements
Subjects will be treated with the Monarch® system using multiple frequency/intensity combination settings. After adjusting the therapy to the desired setting, subjects will be instructed breath through the mouthpiece for the flow measurement system, to breathe normally and continue relaxed breathing. Oscillating flow and volume measurement will be captured by the system over a period of 30 to 60 seconds of relaxed breathing.
Data from the measurement of oscillating flow for each frequency/intensity combination setting will be processed following the completion of the testing
Measured: 4-6 hours
Secondary outcomes (2)
Oscillating volume
Oscillating volume measurement will be conducted concurrently with the measurement of flow. Subjects will be treated with the Monarch® system using multiple frequency/intensity combination settings as described above.
Data from the measurement of oscillating volume for each frequency/intensity combination setting will be processed following the completion of the testing
Measured: 4-6 hours
Patient comfort/discomfort evaluated by 100 mm visual analogue scale (VAS)
Following the completion of testing for each frequency/intensity combination setting, subjects will rate the level of comfort/discomfort of the setting on a VAS.
A Visual Analogue Scale is a psychometric response scale which will be used as a measuring instrument for subjective comfort or discomfort. It is a measurement instrument that ranges across a continuum of values and used to measure the intensity or frequency of various symptoms.
- The Visual Analogue Scale ranges from (0 to 100 mm).
- Zero means very uncomfortable/intolerable and 100 means very comfortable.
The subject will mark the line for each setting combination to indicate the level of comfort or discomfort.
After the Study visit, the research staff will measure the mark on the line and document the value.
Measured: 4-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start24 Jan 2019 (estimated)
- Primary completion12 Mar 2019 (estimated)
- Study completion12 Apr 2019 (estimated)
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hill-Rom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645473
- Sponsor's protocol ID
- CR-RR-2018-002
- Acronym
- HFCWO
- Status last verified
- Dec 2018
- First submitted
- 22 Aug 2018
- Last updated
- 31 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Device Settings for Airway Clearance Using The Monarch Airway Clearance System
- ClinicalTrials.gov ID
- NCT03645473
- Acronym / sponsor ID
- HFCWO / CR-RR-2018-002
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hill-RomIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2019 (estimated)
- Primary completion
- 12 Mar 2019 (estimated)
- Study completion
- 12 Apr 2019 (estimated)
- First posted
- 24 Aug 2018 (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 study will be an open label laboratory study with all subjects receiving HFCWO with The Monarch® System
Objective:
Assess device settings and to identify frequency/pressure (intensity) combinations that produce high airflow and oscillating volume
Methodology:
Subjects will receive HFCWO using The Monarch® System at multiple frequency / intensity combinations on a single visit day. Frequency / intensity combinations will be evaluated to determine which settings produce highest airflow and highest oscillating volume.
Detailed description
The study will be an open-label, laboratory study. All enrolled subjects will receive HFCWO therapy with the Monarch® system. The study will be conducted at one (1) site in the US.
The study will evaluate oscillating airflow and oscillating volume induced during therapy with the Monarch® system. Subjects will also rate the comfort of the therapy. Patients with cystic fibrosis (CF) who meet all of the inclusion criteria and none of the exclusion criteria will be enrolled in the study.
Therapy with the Monarch® system will be delivered using multiple frequency/intensity combination settings. The order of settings will be randomized for each study subject. During therapy oscillating flow and volume measurements will be obtained for each frequency/intensity combination. Following each frequency/intensity combination, subjects will respond to a subjective assessment of the comfort of the therapy by rating the comfort on a visual analogue scale (VAS).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monarch device settings assessment group | Experimental | Device: Monarch Airway Clearance SystemPatients with cystic fibrosis who have experience with the Monarch Airway Clearance System will be enrolled in the study. The duration of subject participation is approximately 4 - 6 hours during 1 study visit. Each subject will receive therapy with The Monarch® System at multiple frequency and intensity combinations as defined in the Study procedures. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Documented diagnosis of CF (by sweat test and/or genetics
- Age > 15 years
- Require regular home airway clearance therapy
- Current user of The Monarch® System with a minimum of 4 weeks experience with the device
- Signed informed consent. If patient is a minor, parents/guardians must give written informed consent and patient must give written assent
Key exclusion criteria (8 listed)
- History of pneumothorax within the past 6 months prior to study visit
- History of hemoptysis requiring embolization within the past 12 months prior to study visit or hemoptysis of > 100 ml within a 24-hour period within the past 30 days
- History of lobectomy
- Recent chest surgery or chest trauma
- Inability to perform The Monarch® 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 |
|---|---|---|
| Monarch Airway Clearance SystemHFCWO Airway Clearance Device | Device | Monarch device settings assessment group |
Primary outcome
Peak oscillating expiratory airflow measurements
Time frame: 4-6 hours
Subjects will be treated with the Monarch® system using multiple frequency/intensity combination settings. After adjusting the therapy to the desired setting, subjects will be instructed breath through the mouthpiece for the flow measurement system, to breathe normally and continue relaxed breathing. Oscillating flow and volume measurement will be captured by the system over a period of 30 to 60 seconds of relaxed breathing. Data from the measurement of oscillating flow for each frequency/intensity combination setting will be processed following the completion of the testing
2 secondary outcomes
Oscillating volume
Time frame: 4-6 hours
Patient comfort/discomfort evaluated by 100 mm visual analogue scale (VAS)
Time frame: 4-6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Monarch Airway Clearance System in people with Cystic Fibrosis, run by Hill-Rom.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 31 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Peak oscillating expiratory airflow measurements (time frame: 4-6 hours). 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 31 Dec 2018.