Cystic FibrosisNCT03797677
MN4000 for Treatment of CF and MND Patients in the Home Setting
A study testing MN 4000 in people with Cystic Fibrosis and Motor Neuron Disease, run by Hill-Rom at 1 site in United States.
Trial summary
The study was a non-randomized open label pilot study. It was an observational design conducted at one (1) site in the US. All enrolled subjects received treatment with the MN4000. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Motor Neuron Disease, Airway Clearance Impairment
- What is being tested?
- MN 4000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2017to 30 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented diagnosis of CF or MND
- Age ≥ 18 years
- Signed informed consent
Who cannot join
- Requirement for continuous mechanical ventilation
- Anticipated requirement for hospitalization within the next three months
- History of pneumothorax within past 6 months
- History of hemoptysis requiring embolization within past 12 months
- Inability to perform MN4000 therapy using a mouthpiece (e.g. inability to create adequate mouth seal)
- Inability to perform MN4000 therapy as directed
- Inability or unwillingness to complete study visits or provide follow-up data as required by the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Evaluate the Use of the MN4000 for Treatment of Cystic Fibrosis (CF) and Motor Neuron Disease (MND) Patients in the Home Setting
The study was a non-randomized open label pilot study. It was an observational design conducted at one (1) site in the US. All enrolled subjects received treatment with the MN4000.
This pilot study evaluated subject satisfaction with the therapy and adherence to the therapy during the 90-day treatment period, and also collected clinical outcome data. Outcomes were assessed before, during and after the MN4000 treatment period.
Read the detailed description
The study was a non-randomized open label pilot study. It was an observational design conducted at one (1) site in the US. All enrolled subjects received treatment with the MN4000.
This pilot study evaluated subject satisfaction with the therapy and adherence to the therapy during the 90-day treatment period, and also collected clinical outcome data. Outcomes were assessed before, during and after the MN4000 treatment period. The study did not include a control group. This pilot study was designed to provide initial information that could inform decisions for future larger-scale studies.
Ten (10) patients total were enrolled from CF and NMD clinics. Eligible subjects were adult patients who were able to perform MN4000 therapy using a mouthpiece and who met all inclusion and none of the exclusion criteria.
All patients received therapy with the MN4000 following the labeled instructions for the device.
The MN4000 is an airway clearance and lung expansion therapy device that has been cleared to market by the FDA as The MetaNeb® System for Homecare environment, for clearance of pulmonary secretions and for treatment or prevention of pulmonary atelectasis. It is a Class II device, cleared to market on March 17, 2016 under premarket notification 510(k) K151689 as The MetaNeb® 4 System with application for homecare environment. It is commercially marketed as the MN4000. The device consists of a pneumatic compressor and an air pulse generator that delivers CHFO and CPEP to;
- facilitate clearance of mucous from the lungs;
- provide lung expansion therapy and;
- enhance delivery of aerosol therapy.
This "triple" mode device can provide aerosol therapy while alternating between CPEP for lung expansion and CHFO for airway clearance. Supplemental oxygen therapy may also be delivered when used with compressed oxygen.
The MN4000 has three therapy modes:
- CHFO (Continuous High Frequency Oscillation) - delivers aerosol therapy while providing oscillating pressure pulses to the airway
- CPEP (Continuous Positive Expiratory Pressure) - delivers aerosol therapy while providing continuous positive pressure to help hold open and expand the airways
- Aerosol - for delivery of aerosol only. In this mode, CHFO and CPEP are not available
After assessing baseline status, therapy with the MN4000 was introduced and incorporated into the daily home respiratory care treatment regimen for all patients.
Other airway clearance and/or lung expansion therapies were not to be performed during the three-month study period. The treatment regimen for other respiratory care modalities (e.g. aerosolized medications) was that which was prescribed by the patient's health care team in the routine standard care of each patient.
During the three-month follow-up period, adherence to the daily prescribed therapy regimen was assessed. Subjects/caregivers were asked to provide adherence information for each day during the 90-day study period.
Documentation of efficacy and safety Variables was completed by study staff at the time of occurrence, from review of the patient's medical records and from scores and rankings for questionnaires.
- Being tested
- MN 4000
- Keywords
- Airway Clearance, Cystic Fibrosis, Motor Neuron Disease, Home care
- Medical subject headings
- Cystic Fibrosis, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MN 4000Device
Patients who required regular home airway clearance therapy were enrolled in the study and were prescribed therapy with the MN4000. Adherence to the prescribed therapy regimen and patient/caregiver satisfaction with the therapy was assessed. Pulmonary function, was assessed for each subject at baseline, after 1 month and after 3 months of home therapy. Results from the therapy period was compared to the baseline period, during which the subject received their regular airway clearance regimen. Airway Clearance Satisfaction surveys were conducted at baseline, after 1 month, and after 3 months of therapy. Results from the MN4000 therapy period were compared to the baseline period, during which the subject received their regular regimen
| Study group | Role | What they receive |
|---|---|---|
| Home based airway clearance with Metaneb | Experimental | Patients with CF and MND who required regular home airway clearance therapy were enrolled to use the Metaneb device in the home setting.
The MN4000 is an airway clearance and lung expansion therapy device that has been cleared to market by the FDA as The MetaNeb® System for Homecare environment, for clearance of pulmonary secretions and for treatment or prevention of pulmonary atelectasis. It is a Class II device, cleared to market on March 17, 2016 under premarket notification 510(k) K151689 as The MetaNeb® 4 System with application for homecare environment. Receives: Device: MN 4000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient / Caregiver Satisfaction Scores
The primary efficacy variable was patient and/or caregiver satisfaction with therapy, as evaluated using a Therapy Use Rating Questionnaire.
The questionnaire was used to assess change in satisfaction or effectiveness on a variety of parameters.
The satisfaction score was completed by the patient, if possible. Some of the patients in this study had Motor Neuron Disease. This disease can compromise the ability of the patient to interact and to respond to questions. In situations where patients could not respond, caregivers were asked to respond on their behalf.
Measured: 90 days
Patient / Caregiver Satisfaction Scores
The Therapy Use Rating Questionnaire is an assessment of patient/caregiver satisfaction with the therapy and their subjective assessment of the benefit of the therapy.
The questionnaire was used to assess change in satisfaction or effectiveness on a variety of parameters.
The satisfaction score was completed by the patient, if possible. Some of the patients in this study had Motor Neuron Disease This disease can compromise the ability of the patient to interact and to respond to questions. In situations where patients could not respond, caregivers were asked to respond on their behalf.
Measured: 90 days
Secondary outcomes (14)
Mean Percentage Adherence to Prescribed Treatment Regimen
Adherence to the treatment regimen was calculated for each patient (number of minutes of therapy performed / number of minutes of therapy prescribed). The adherence percentage calculated for each study subject was then used to calculate the of Mean adherence to prescribed treatment regimen for the group or groups.
Measured: 90 days
ALS-Functional Rating Scale (ALS-FRS)
MND patients only. The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) is an instrument for evaluating the functional status of patients with Amyotrophic Lateral Sclerosis. It can be used to monitor functional change in a patient over time.
It contains 10 distinct measures:
- Speech
- Salivation
- Swallowing
- Handwriting
- Cutting food and handling utensils (with or without gastrostomy)
- Dressing and hygiene
- Turning in bed and adjusting bed clothes
- Walking
- Breathing
- Climbing stairs
These 10 parameters are scored on a scale of 0-4, based on the patients' ability to perform tasks. The minimum score is 0 and maximum 40.The higher the score the more function is retained.
Measured: 90 days
Cystic Fibrosis Questionnaire - Revised (CFQ-R)
CF patients only. The Cystic Fibrosis Questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQoL) for adolescents and adults with cystic fibrosis (CF) > or = 14 years, consisting of 44 items on 12 generic and disease-specific scales. It offers 5 distinct 4-point Likert scales (e.g., always/often/ sometime/never). Scores for each HRQoL domain; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health.
Measured: 90 days
Number of Participants With Exacerbation of Pulmonary Disease
Hospitalization and/or antibiotics for respiratory infection or complication. Exacerbations of pulmonary disease were defined as respiratory infections that resulted in the requirement for hospitalization and/or antibiotics to treat the respiratory infection or complication. Hospitalizations that are part of routine care (e.g. hospital admissions for annual "tune-up") or antibiotics that are part of the regular treatment regimen were not documented as exacerbations. Occurrence of exacerbation related hospitalization OR the necessity of a prescription for antibiotics qualify as worsening disease.
Measured: 90 days
FEV1 (Actual)
FEV1 is the actual volume measured in liters.
Forced expiratory volume in one second (FEV1): The forced expiratory volume-one second is the total volume of air a patient exhales in the first second during maximal effort. Normal range is >80%. The patient takes a full breath in and exhale as hard and fast as they can. FEV1 refers to the volume of air that an individual can exhale during a forced breath in the first 1 second. Decreasing percentage is associated with worsening / severe disease
Measured: 90 days
FEV1 (% Predicted)
FEV1 Percent Predicted (FEV1 % Predicted) is the actual volume exhaled in the first 1 second, divided by the "Normal" value for that actual value for a person of that age, gender, height and weight. A nomogram based on population norms provides a series of "Normal Values."
FEV1: The forced expiratory volume-one second is the total volume of air a patient exhales in the first second during maximal effort. Normal range is >80%. Decreasing percentage is associated with worsening / severe disease
Measured: 90 days
FVC (Actual)
FVC is the actual volume measured in liters.
The functional vital capacity (FVC) is the total volume of air a patient exhales for the total duration of the test during maximal effort. Normal range is >80%. Decreasing percentage is associated with worsening / severe disease.
FVC was only done in CF subjects because performance of the test requires intact respiratory muscle function. CF patients have intact respiratory muscle function and can therefore perform this maneuver. Patients with Motor Neuron Disease suffer from progressive weakness of all muscles including the respiratory muscles. The test results for FVC are affected muscle weakness and are therefore not a valid representation of their pulmonary function.
Measured: 90 days
FVC (% Predicted)
FVC Percent Predicted (FVC % Predicted) is the actual volume exhaled in the first 1 second, divided by the "Normal" value for that actual value for a person of that age, gender, height and weight. A nomogram based on population norms provides a series of "Normal Values."
The functional vital capacity is the total volume of air a patient exhales for the total duration of the test during maximal effort. Normal range is >80%. Decreasing percentage is associated with worsening / severe disease.
FVC was only done in CF subjects because performance of the test requires intact respiratory muscle function. CF patients have intact respiratory muscle function and can therefore perform this maneuver. Patients with Motor Neuron Disease suffer from progressive weakness of all muscles including the respiratory muscles. The test results for FVC are affected muscle weakness and are therefore not a valid representation of their pulmonary function.
Measured: 90 days
FEV1/FVC Ratio
The proportion of the FVC expired in one second Results are given in both actual values (litres, litres per second) and %predicted-the test result as a percent of the "predicted values" for the patients of similar characteristics. Results over 80% are considered normal.
Patients with Motor Neuron Disease suffer from progressive weakness of all muscles including the respiratory muscles. The test results for FVC are affected muscle weakness and are therefore not a valid representation of their pulmonary function.
Measured: 90 days
SVC (Actual)
Slow Vital Capacity (SVC) is the actual volume measured in liters.
Slow Vital Capacity displays the volume of gas measured on a complete expiration after a maximal inspiration without forced or rapid effort. Useful measurement when FVC is reduced, and airway obstruction is present. Educed SVC is associated with worsening respiratory disease.
Slow Vital Capacity provides the same measure as FVC - i.e. "Vital Capacity." It does not, however, require a "Forced expiratory maneuver (it requires a slow inspiration and slow expiration) and therefore is easier to achieve a valid result in patients with Motor Neuron Disease who suffer from progressive weakness of all muscles including the respiratory muscles.
Measured: 90 days
SVC (% Predicted)
SVC Percent Predicted (SVC % Predicted) is the actual volume exhaled in the first 1 second, divided by the "Normal" value for that actual value for a person of that age, gender, height and weight. A nomogram based on population norms provides a series of "Normal Values."
Slow Vital Capacity displays the volume of gas measured on a complete expiration after a maximal inspiration without forced or rapid effort. Useful measurement when FVC is reduced and airway obstruction is present. Educed SVC is associated with worsening respiratory disease.
Slow Vital Capacity provides the same measure as FVC - i.e. "Vital Capacity." It does not, however, require a "Forced expiratory maneuver (it requires a slow inspiration and slow expiration) and therefore is easier to achieve a valid result in patients with Motor Neuron Disease who suffer from progressive weakness of all muscles including the respiratory muscles.
Measured: 90 days
SpO2
Standard pulmonary function measures (FEV1, FVC, and FEV1/FVC) are commonly followed in the clinical care of patients with CF.
Standard pulmonary function measures (SVC, SpO2, MIP, and Peak Cough Flow) are commonly followed in the clinical care of patients with MND.
SpO2 stands for peripheral capillary oxygen saturation, an estimate of the amount of oxygen in the blood. Low SpO2 is associated with worsening respiratory function.
Measured: 90 days
Maximal Inspiratory Pressure (MIP)
Standard pulmonary function measures (FEV1, FVC, and FEV1/FVC) are commonly followed in the clinical care of patients with CF.
Standard pulmonary function measures (SVC, SpO2, MIP, and Peak Cough Flow) are commonly followed in the clinical care of patients with MND.
Maximal inspiratory pressure (MIP) is a measure of the strength of inspiratory muscles, primarily the diaphragm, and allows for the assessment of ventilatory failure, restrictive lung disease and respiratory muscle strength. Reduction in MIP is asociated with worsening neuromuscular status and poor ability to cough.
Measured: 90 days
PCF
Standard pulmonary function measures (FEV1, FVC, and FEV1/FVC) are commonly followed in the clinical care of patients with CF.
Standard pulmonary function measures (SVC, SpO2, MIP, and PCF) are commonly followed in the clinical care of patients with MND.
The Peak Cough Flow (PCF) is the maximum air flow generated during a cough. Decreasing air flow generated is associated with weakening neuromuscular status and associated poor cough impulse
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start9 Mar 2017
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hill-Rom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa F Wolfe, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797677
- Sponsor's protocol ID
- CR-RR2016-002
- Status last verified
- Jul 2024
- First submitted
- 27 Dec 2018
- Last updated
- 7 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Use of the MN4000 for Treatment of Cystic Fibrosis (CF) and Motor Neuron Disease (MND) Patients in the Home Setting
- ClinicalTrials.gov ID
- NCT03797677
- Acronym / sponsor ID
- CR-RR2016-002
- Keywords
- Airway Clearance, Cystic Fibrosis, Motor Neuron Disease, Home care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hill-RomIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 9 Jan 2019 (actual)
- Results
- Posted 7 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was a non-randomized open label pilot study. It was an observational design conducted at one (1) site in the US. All enrolled subjects received treatment with the MN4000.
This pilot study evaluated subject satisfaction with the therapy and adherence to the therapy during the 90-day treatment period, and also collected clinical outcome data. Outcomes were assessed before, during and after the MN4000 treatment period.
Detailed description
The study was a non-randomized open label pilot study. It was an observational design conducted at one (1) site in the US. All enrolled subjects received treatment with the MN4000.
This pilot study evaluated subject satisfaction with the therapy and adherence to the therapy during the 90-day treatment period, and also collected clinical outcome data. Outcomes were assessed before, during and after the MN4000 treatment period. The study did not include a control group. This pilot study was designed to provide initial information that could inform decisions for future larger-scale studies.
Ten (10) patients total were enrolled from CF and NMD clinics. Eligible subjects were adult patients who were able to perform MN4000 therapy using a mouthpiece and who met all inclusion and none of the exclusion criteria.
All patients received therapy with the MN4000 following the labeled instructions for the device.
The MN4000 is an airway clearance and lung expansion therapy device that has been cleared to market by the FDA as The MetaNeb® System for Homecare environment, for clearance of pulmonary secretions and for treatment or prevention of pulmonary atelectasis. It is a Class II device, cleared to market on March 17, 2016 under premarket notification 510(k) K151689 as The MetaNeb® 4 System with application for homecare environment. It is commercially marketed as the MN4000. The device consists of a pneumatic compressor and an air pulse generator that delivers CHFO and CPEP to;
- facilitate clearance of mucous from the lungs;
- provide lung expansion therapy and;
- enhance delivery of aerosol therapy.
This "triple" mode device can provide aerosol therapy while alternating between CPEP for lung expansion and CHFO for airway clearance. Supplemental oxygen therapy may also be delivered when used with compressed oxygen.
The MN4000 has three therapy modes:
- CHFO (Continuous High Frequency Oscillation) - delivers aerosol therapy while providing oscillating pressure pulses to the airway
- CPEP (Continuous Positive Expiratory Pressure) - delivers aerosol therapy while providing continuous positive pressure to help hold open and expand the airways
- Aerosol - for delivery of aerosol only. In this mode, CHFO and CPEP are not available
After assessing baseline status, therapy with the MN4000 was introduced and incorporated into the daily home respiratory care treatment regimen for all patients.
Other airway clearance and/or lung expansion therapies were not to be performed during the three-month study period. The treatment regimen for other respiratory care modalities (e.g. aerosolized medications) was that which was prescribed by the patient's health care team in the routine standard care of each patient.
During the three-month follow-up period, adherence to the daily prescribed therapy regimen was assessed. Subjects/caregivers were asked to provide adherence information for each day during the 90-day study period.
Documentation of efficacy and safety Variables was completed by study staff at the time of occurrence, from review of the patient's medical records and from scores and rankings for questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home based airway clearance with Metaneb | Experimental | Device: MN 4000Patients with CF and MND who required regular home airway clearance therapy were enrolled to use the Metaneb device in the home setting. The MN4000 is an airway clearance and lung expansion therapy device that has been cleared to market by the FDA as The MetaNeb® System for Homecare environment, for clearance of pulmonary secretions and for treatment or prevention of pulmonary atelectasis. It is a Class II device, cleared to market on March 17, 2016 under premarket notification 510(k) K151689 as The MetaNeb® 4 System with application for homecare environment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented diagnosis of CF or MND
- Age ≥ 18 years
- Signed informed consent
Key exclusion criteria (7 listed)
- Requirement for continuous mechanical ventilation
- Anticipated requirement for hospitalization within the next three months
- History of pneumothorax within past 6 months
- History of hemoptysis requiring embolization within past 12 months
- Inability to perform MN4000 therapy using a mouthpiece (e.g. inability to create adequate mouth seal)
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 |
|---|---|---|
| MN 4000Patients who required regular home airway clearance therapy were enrolled in the study and were prescribed therapy with the MN4000. Adherence to the prescribed therapy regimen and patient/caregiver satisfaction with the therapy was assessed. Pulmonary function, was assessed for each subject at baseline, after 1 month and after 3 months of home therapy. Results from the therapy period was compared to the baseline period, during which the subject received their regular airway clearance regimen. Airway Clearance Satisfaction surveys were conducted at baseline, after 1 month, and after 3 months of therapy. Results from the MN4000 therapy period were compared to the baseline period, during which the subject received their regular regimen | Device | Home based airway clearance with Metaneb |
Primary outcome
Patient / Caregiver Satisfaction Scores
Time frame: 90 days
The primary efficacy variable was patient and/or caregiver satisfaction with therapy, as evaluated using a Therapy Use Rating Questionnaire. The questionnaire was used to assess change in satisfaction or effectiveness on a variety of parameters. The satisfaction score was completed by the patient, if possible. Some of the patients in this study had Motor Neuron Disease. This disease can compromise the ability of the patient to interact and to respond to questions. In situations where patients could not respond, caregivers were asked to respond on their behalf.
Patient / Caregiver Satisfaction Scores
Time frame: 90 days
The Therapy Use Rating Questionnaire is an assessment of patient/caregiver satisfaction with the therapy and their subjective assessment of the benefit of the therapy. The questionnaire was used to assess change in satisfaction or effectiveness on a variety of parameters. The satisfaction score was completed by the patient, if possible. Some of the patients in this study had Motor Neuron Disease This disease can compromise the ability of the patient to interact and to respond to questions. In situations where patients could not respond, caregivers were asked to respond on their behalf.
14 secondary outcomes
Mean Percentage Adherence to Prescribed Treatment Regimen
Time frame: 90 days
ALS-Functional Rating Scale (ALS-FRS)
Time frame: 90 days
Cystic Fibrosis Questionnaire - Revised (CFQ-R)
Time frame: 90 days
Number of Participants With Exacerbation of Pulmonary Disease
Time frame: 90 days
FEV1 (Actual)
Time frame: 90 days
FEV1 (% Predicted)
Time frame: 90 days
FVC (Actual)
Time frame: 90 days
FVC (% Predicted)
Time frame: 90 days
FEV1/FVC Ratio
Time frame: 90 days
SVC (Actual)
Time frame: 90 days
SVC (% Predicted)
Time frame: 90 days
SpO2
Time frame: 90 days
Maximal Inspiratory Pressure (MIP)
Time frame: 90 days
PCF
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Lisa F Wolfe, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MN 4000 in people with Cystic Fibrosis and Motor Neuron Disease, run by Hill-Rom at 1 site in United States.
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 3 inclusion and 7 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 7 Aug 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 7 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient / Caregiver Satisfaction Scores (time frame: 90 days). The study lists 2 primary outcomes in all. 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 7 Aug 2024.