A Study for the Assessment of the Benefits of a Novel Mesh Nebulizer in the Treatment of Patients With Stable COPD

COPD Clinical Trial

Official title: A Study for the Assessment of the Benefits of a Novel Mesh Nebulizer in the Treatment of Patients With Stable COPD

Status Completed

Clinical Trial Summary

Jet nebulizers have been the standard delivery system for aerosolized medications commonly prescribed to Chronic Obstructive Pulmonary Disease (COPD) patients; however, these devices are inefficient and require an external pressurized gas source to operate. Vibrating mesh nebulizers have a significantly higher efficiency of delivering drugs to the lung compared to conventional jet or ultrasonic nebulizers because of the high fine particle fraction created by the rapid vibration. This post-market study will investigate the potential benefits of a vibrating mesh nebulizer compared a standard jet nebulizer. The study will include stable, ambulatory COPD patients who are currently using a jet nebulizer system. Participants will be asked to use each device for a period of 30 days. Patient preference and changes to quality of life will be evaluated.

Clinical Trial Description

Participants will be contacted by designated study site staff. Participants may be pre-screened through medical records over the phone to assess potential eligibility. A screening script will include a general review of key inclusion and exclusion criteria. Participants that are interested will be scheduled for a screening visit at the clinical office.

Visit 1 - Screening/Baseline:

Once the participant arrives, the study will be explained in full detail. If the participant agrees, he/she will be consented into the study and the participant will be given a copy of the informed consent. After the consent is signed, the following procedures will be performed:

Demographics

Medical History

Concomitant Medication

mMRC

Chronic Respiratory Disease Questionnaire (CRQ) Self-Reported (SR)

Pulmonary Function Tests

Vital Signs prior to 6 Minute Walk (6MW)

6-Minute Walk Test (6MWT)

Modified Borg Assessment

Inclusion/Exclusion Criteria Review

Device Photograph

Randomization Participants will be randomly assigned to either their current jet nebulizer or the InnoSpire Go device for the first 30 days of treatment.

Training Session Participants randomized to InnoSpire Go in the first treatment arm will be trained on the use and cleaning of the device before being sent home.

Visit 2 - Interim Visit:

Participants will be asked to return to the research center 15 days ± 3 days after Visit 1.

Side Effect and Adverse Event Assessment Participants will be asked about any side effects or adverse events (AEs) since the last visit.

Concomitant Medications

CRQ-SR (Follow-Up)

Nebulizer Satisfaction Assessment Participant satisfaction with the device used in the first treatment arm will be assessed.

Visit 3 - Cross-over:

Participants will be asked to return to the research center within 30 days ± 3 days after Visit 1. They will be instructed to bring the first assigned study device and their prescribed albuterol or combination albuterol/ipratropium medication for the demonstration.

CRQ-SR (Follow-Up)

Concomitant Medications

Device Use Demonstration

Nebulizer Weight The nebulizer cup/reservoir alone will be weighed with the medication before device use and after device use to capture residual medication. This process will take place during video recording.

Peak inspiratory flow (PIF)

Vital Signs prior to 6MW

. Modified Borg Assessment

6-Minute Walk Test

Nebulizer Satisfaction Assessment Participant satisfaction with the device used in the first treatment arm will be assessed.

Training Session Participants randomized to InnoSpire Go in the second treatment arm will be trained on the use and cleaning of the device before being sent home.

Visit 4 - Interim Visit:

Participants will be asked to return to the research center 15 days ± 3 days after Visit 3. Participants will complete procedures outlined in Visit 2.

Visit 5 -Final Visit:

Participants will return to the clinical facility 30 days (± 3 days) after Visit 3 completion. They will be instructed to bring the second assigned study device and their prescribed albuterol or combination albuterol/ipratropium medication for the demonstration. Participants will complete the procedures outlined in Visit 3. Participants will need to return all study equipment at this visit.

Participants will be discharged from the study following completion of study procedures. ;

Related Conditions & MeSH terms

• COPD

• NCT number: NCT03933462
• Study type: Interventional
• Source: Philips Respironics
• Status: Completed
• Phase: N/A
• Start date: June 12, 2019
• Completion date: October 28, 2019