Oscillation and Lung Expansion (OLE) Therapy for Treatment of Neuromuscular Disease (NMD) Patients

NCT05366010 | Terminated Results FDA Device

• 1 other identifier: CR-RR-2020-005
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be a non-randomized open label pilot study comparing a retrospective control period to an active treatment period with oscillation and lung expansion (OLE) therapy.

Conditions

Neuromuscular Diseases

Outcome Measures

Primary Outcomes (1)

• Frequency of Exacerbations of Pulmonary Disease Requiring Medical Intervention

  Exacerbation of pulmonary disease is a worsening of pulmonary condition or an event requiring one or more of the following: * Hospitalization * Emergency Department visit * Unscheduled antibiotics * Unscheduled outpatient visit

  6 months pre-treatment and 6 months post-treatment with the Volara System

Secondary Outcomes (16)

• Slow Vital Capacity

  Baseline and monthly for 6 months

• Peak Cough Flow

  Baseline and monthly for 6 months

• Resting Oxygen Saturation

  Baseline and monthly for 6 months

• Maximal Inspiratory Pressure

  Baseline and monthly for 6 months

• Number of Hospital Admissions

  6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System

Study Arms (1)

Intervention

EXPERIMENTAL

Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention

Device: Oscillation and Lung Expansion (OLE) therapy

Interventions

Oscillation and Lung Expansion (OLE) therapy DEVICE

Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure

Intervention

Eligibility Criteria

• Age: 5 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented diagnosis of neuromuscular disease (NMD) or neurological disorder.
• Age 5 to 80 years.
• History of one or more respiratory exacerbations in the past 6 months or two or more respiratory exacerbations in the past 12 months, which required unplanned or unscheduled medical intervention.
• Ability to perform Oscillation and Lung Expansion (OLE) therapy as directed.
• Signed informed consent (and assent if minor patient).
• Patients who meet any of the following criteria will be excluded from the study:
• Diagnosis with rapidly progressing NMD such as certain types of Motor Neuron Disease (MND).
• Requirement for continuous mechanical ventilation.
• Anticipated requirement for respiratory related hospitalization within the next six months.
• History of pneumothorax within the past 6 months.
• History of hemoptysis requiring embolization within past 12 months.
• Pregnancy.
• Home use of OLE therapy within the past 12 months.
• Inability or unwillingness to perform OLE therapy or study procedures as required.

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead
• Science 37: collaborator

Study Sites (1)

Science 37

Durham, North Carolina, 27709, United States

Location

MeSH Terms

Conditions

Neuromuscular Diseases

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Nervous System Diseases

Limitations and Caveats

It may be that only the first pulmonary exacerbation in the 6 months before using Volara was recorded for patient enrollment. Early termination led to a small number of patients being analyzed. Some patients were unable to undergo all planned analyses, such as Pulmonary Function Tests. Selected patient population was broad in age and disease implying variability in disease trajectory and/or severity at enrollment.

Results Point of Contact

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

Global_CORP_ClinicalTrialsDisclosure@baxter.com

(224) 948-7359

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Model Details: Study subjects will serve as their own control. Medical records will be reviewed for each study subject for the twelve-month period prior to initiation of OLE therapy. The study will compare the frequency of exacerbations experienced prior to treatment with OLE to the frequency of exacerbations experienced in the active treatment period, during which study subjects receive treatment with The Volara® System. In addition, specific healthcare utilization indicators including hospitalizations, antibiotic use, and emergency department (ED) visits for pulmonary complications will be documented for each study period.

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 9, 2022
• Study Start: November 4, 2021
• Primary Completion: February 27, 2024
• Study Completion: February 27, 2024
• Last Updated: July 31, 2025
• Results First Posted: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)