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

NCT03797677 | Completed Results FDA Device

• 1 other identifier: CR-RR2016-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis; Motor Neuron Disease; Airway Clearance Impairment

Keywords

Airway Clearance; Cystic Fibrosis; Motor Neuron Disease; Home care

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  90 days

Secondary Outcomes (14)

• Mean Percentage Adherence to Prescribed Treatment Regimen

  90 days

• ALS-Functional Rating Scale (ALS-FRS)

  90 days

• Cystic Fibrosis Questionnaire - Revised (CFQ-R)

  90 days

• Number of Participants With Exacerbation of Pulmonary Disease

  90 days

• FEV1 (Actual)

  90 days

Study Arms (1)

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.

Device: MN 4000

Interventions

MN 4000 DEVICE

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

Home based airway clearance with Metaneb

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented diagnosis of CF or MND
• Age ≥ 18 years
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Hill-Rom: lead

Study Sites (1)

Northwestern

Chicago, Illinois, 60208, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Motor Neuron Disease

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases

Results Point of Contact

• Title: Baxter Clinical Trials Disclosure Call Center
• Organization: Baxter Healthcare

Global_CORP_ClinicalTrialsDisclosure@baxter.com

(224) 948-7359

Study Officials

• Lisa F Wolfe, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: January 9, 2019
• Study Start: March 9, 2017
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: August 7, 2024
• Results First Posted: August 7, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)