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NCT03797677

MN4000 for Treatment of CF and MND Patients in the Home Setting

Completed NA Results posted Last updated 7 August 2024
What this trial tests

NA trial testing MN 4000 in Cystic Fibrosis in 10 participants. Completed in 30 November 2017.

Timeline
9 March 2017
Primary endpoint
30 November 2017
30 November 2017

Quick facts

Lead sponsorHill-Rom
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment10
Start date9 March 2017
Primary completion30 November 2017
Estimated completion30 November 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Hill-Rom

Who can join

18 and older, any sex, with Cystic Fibrosis or Motor Neuron Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient / Caregiver Satisfaction Scores Primary · 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.

Difficulty of Use (Day 30)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.0
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.4
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.4
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.1
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.0
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Missed Treatment (Day 30)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.2
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.2
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.2
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.2
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.1
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.0
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Bring up sputum (Day 30)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.4
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.3
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.1
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.0
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Shortness of breath (Day 30)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.0
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.2
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.2
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.1
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.2
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.2
Lungs stay healthy (Day 30)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.0
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.3
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.4
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.2
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.0
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Ability to perform tasks (Day 30)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.1
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.2
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.2
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.2
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.2
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.0
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Difficulty of Use (Day 90)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.0
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.1
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.3
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.3
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.2
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.1
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.0
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Missed Treatment (Day 90)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.3
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.1
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.3
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.1
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.0
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Patient / Caregiver Satisfaction Scores Primary · 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.

Effective (Day 30)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.0
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.2
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.2
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.2
Easy to perform (Day 30)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.2
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.1
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.1
Like to continue MN4000 (Day 30)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.0
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.0
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Effective (Day 90)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.0
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.1
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.3
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.0
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.1
Easy to perform (Day 90)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.2
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.1
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.2
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.0
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.1
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.1
Like to continue MN4000 (Day 90)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.1
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.0
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.0
Mean Percentage Adherence to Prescribed Treatment Regimen Secondary · 90 days

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.

GroupValue95% CI
Patients With CF Who Required Home Based Airway Clearance With Metaneb9786 – 100
Patients With MND Who Required Home Based Airway Clearance With Metaneb9589.7 – 99.5
ALS-Functional Rating Scale (ALS-FRS) Secondary · 90 days

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 p

Bulbar Sub-Score at Baseline
GroupValue95% CI
Home Based Airway Clearance With Metaneb10.8± 1.64
Bulbar Sub-Score after 30 days of therapy
GroupValue95% CI
Home Based Airway Clearance With Metaneb10.0± 3.39
Bulbar Sub-Score after 90 days of therapy
GroupValue95% CI
Home Based Airway Clearance With Metaneb10.4± 3.05
Respiratory Sub-score at baseline
GroupValue95% CI
Home Based Airway Clearance With Metaneb9.4± 1.52
Respiratory Sub-score after 30 days of therapy
GroupValue95% CI
Home Based Airway Clearance With Metaneb10.2± 1.10
Respiratory Sub-score after 90 days of therapy
GroupValue95% CI
Home Based Airway Clearance With Metaneb10.2± 1.10
Total Score at Baseline
GroupValue95% CI
Home Based Airway Clearance With Metaneb33.6± 6.84
Total Score after 30 days of therapy
GroupValue95% CI
Home Based Airway Clearance With Metaneb32.0± 5.29
Cystic Fibrosis Questionnaire - Revised (CFQ-R) Secondary · 90 days

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.

Physical domain at baseline
GroupValue95% CI
Home Based Airway Clearance With Metaneb83.3± 19.54
Physical domain after 30 days of therapy
GroupValue95% CI
Home Based Airway Clearance With Metaneb78.3± 20.28
Physical domain after 90 days of therapy
GroupValue95% CI
Home Based Airway Clearance With Metaneb80.0± 17.78
Role domain at baseline
GroupValue95% CI
Home Based Airway Clearance With Metaneb80.0± 7.45
Role domain after 30 days of therapy
GroupValue95% CI
Home Based Airway Clearance With Metaneb90.0± 6.97
Role domain after 90 days of therapy
GroupValue95% CI
Home Based Airway Clearance With Metaneb86.7± 11.18
Vitality domain at baseline
GroupValue95% CI
Home Based Airway Clearance With Metaneb75.0± 16.67
Vitality domain after 30 days of therapy
GroupValue95% CI
Home Based Airway Clearance With Metaneb73.3± 6.97
Number of Participants With Exacerbation of Pulmonary Disease Secondary · 90 days

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 diseas

Exacerbation of pulmonary disease at baseline
GroupValue95% CI
Home Based Airway Clearance With Metaneb2
Exacerbation that required antibiotics but not hospitalization at Day 30
GroupValue95% CI
Home Based Airway Clearance With Metaneb1
Exacerbations that required antibiotics at Day 90
GroupValue95% CI
Home Based Airway Clearance With Metaneb3
FEV1 (Actual) Secondary · 90 days

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

FEV1 measure at baseline (Actual)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1.8± 0.94
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.1.7± 0.54
FEV1 measure after 30 days of therapy (Actual)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1.9± 1.05
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.1.6± 0.71
FEV1 measure after 90 days of therapy (Actual)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.1.9± 0.93
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.1.7± 0.73
FEV1 (% Predicted) Secondary · 90 days

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

FEV1 measure at baseline (% Predicted)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.55.2± 25.49
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.58.6± 19.49
FEV1 measure after 30 days of therapy (% Predicted)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.58.8± 27.81
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.57.8± 28.42
FEV1 measure after 90 days of therapy (% Predicted)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.60.4± 24.76
Home Based Airway Clearance With Metaneb in Patients With Motor Neuron Disease.59.4± 27.67
FVC (Actual) Secondary · 90 days

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. T

FVC at baseline (Actual)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.2.6± 0.98
FVC after 30 days of therapy (Actual)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.2.6± 1.08
FVC after 90 days of therapy (Actual)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.2.7± 0.99
FVC (% Predicted) Secondary · 90 days

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 f

FVC at baseline (% Predicted)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.68.6± 22.09
FVC after 30 days of therapy (% Predicted)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.69.8± 23.19
FVC after 90 days of therapy (% Predicted)
GroupValue95% CI
Home Based Airway Clearance With Metaneb in Patients With Cystic Fibrosis.71.0± 21.30
FEV1/FVC Ratio Secondary · 90 days

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.

FEV1/FVC at baseline
GroupValue95% CI
Home Based Airway Clearance With Metaneb78.4± 19.78
FEV1/FVC after 30 days of therapy
GroupValue95% CI
Home Based Airway Clearance With Metaneb81.4± 18.42
FEV1/FVC after 90 days of therapy
GroupValue95% CI
Home Based Airway Clearance With Metaneb82.4± 14.54
SVC (Actual) Secondary · 90 days

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 w

SVC at baseline (Actual)
GroupValue95% CI
Home Based Airway Clearance With Metaneb2.1± 0.50
SVC after 30 days of therapy (Actual)
GroupValue95% CI
Home Based Airway Clearance With Metaneb2.2± 0.66
SVC after 90 days of therapy (Actual)
GroupValue95% CI
Home Based Airway Clearance With Metaneb2.1± 0.89

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Cystic Fibrosis

Currently open trials in the same condition.

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Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03797677.

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