N/A
Completed N=10
MN4000 for Treatment of CF and MND Patients in the Home Setting
Cystic fibrosis · motor neuron disease · Airway Clearance Impairment
Source: ClinicalTrials.gov NCT03797677 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Patient / Caregiver Satisfaction Scores — 0; 0; 4; 4 Participants
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.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient / Caregiver Satisfaction Scores |
0; 0; 1; 0; 2; 2 | — |
| PRIMARY Patient / Caregiver Satisfaction Scores |
0; 0; 1; 0; 2; 2 | — |
| SECONDARY Mean Percentage Adherence to Prescribed Treatment Regimen |
97; 95 | — |
| SECONDARY ALS-Functional Rating Scale (ALS-FRS) |
10.8; 10.0; 10.4; 9.4; 10.2; 10.2 | — |
| SECONDARY Cystic Fibrosis Questionnaire - Revised (CFQ-R) |
83.3; 78.3; 80.0; 80.0; 90.0; 86.7 | — |
| SECONDARY Number of Participants With Exacerbation of Pulmonary Disease |
2; 1; 3 | — |
| SECONDARY FEV1 (Actual) |
1.8; 1.7; 1.9; 1.6; 1.9; 1.7 | — |
| SECONDARY FEV1 (% Predicted) |
55.2; 58.6; 58.8; 57.8; 60.4; 59.4 | — |
| SECONDARY FVC (Actual) |
2.6; 2.6; 2.7 | — |
| SECONDARY FVC (% Predicted) |
68.6; 69.8; 71.0 | — |
| SECONDARY FEV1/FVC Ratio |
78.4; 81.4; 82.4 | — |
| SECONDARY SVC (Actual) |
2.1; 2.2; 2.1 | — |
| SECONDARY SVC (% Predicted) |
55.2; 58.2; 54.6 | — |
| SECONDARY SpO2 |
97.4; 96.8; 95.8 | — |
| SECONDARY Maximal Inspiratory Pressure (MIP) |
-41.0; -35.6; -34.8 | — |
| SECONDARY PCF |
344.0; 320.0; 280.0 | — |
Eligibility Criteria
Inclusion Criteria
- Documented diagnosis of CF or MND
- Age ≥ 18 years
- Signed informed consent
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03797677). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.