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

Completed · Not applicable

Conditions studied: COPD

In brief

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.

Key facts

Study ID

NCT03933462

Run by

Philips Respironics

People needed

21

Starts

2019-06-12

Expected to finish

2019-10-28

Last updated by the study team

2020-12-17

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients ≥ 40 years of age.
• Diagnosis of COPD.
• Currently using only a mouthpiece with their nebulizer system.
• Forced Expiratory Volume at 1 second (FEV1) ≥ 30% predicted (pre or post bronchodilator).
• Modified Medical Research Council (mMRC) Dyspnea scale grade ≥ 1.
• Use of a jet nebulizer for the administration of albuterol or combination albuterol/ipratropium for the past 6 months
• Willing to use the same compressor/nebulizer system throughout the study
• Willing to refrain from using the jet nebulizer system when using InnoSpire Go
• Prescribed nebulizer combination albuterol/ipratropium (single or multiple vials) with self-report of at least daily use or prescribed nebulizer albuterol with self-report of at least twice daily use.
• Willing to permit audio and video recording during the visit.
• Willing and able to follow instructions and complete all activities required by the trial, including phone calls.
• Able to read and understand English.

You may not qualify if…

• Unable to complete 6MWT or, if patient is not currently prescribed oxygen, persistent oxygen desaturation ≤ 88% on the 6MWT.
• Exacerbation of COPD requiring hospitalization in the last 3 months (defined as hospital admission, urgent care visit, or emergency room visit).
• Prescribed non-selective beta blockers.
• Prescribed additional ipratropium bromide via nebulizer or inhaler or any other nebulized treatments via the subject's jet nebulizer.
• Patients currently in assisted living or nursing home.
• Diagnosis of asthma, parenchymal lung disease other than COPD, bronchiectasis, tuberculosis, cor pulmonale, clinically significant obstructive urinary disease, narrow-angle glaucoma, unstable angina, depression, anxiety, or other serious medical condition that, in the opinion of the investigator, would interfere with the patient's participation in the trial.
• History of thoracotomy.
• Myocardial infarction within the last 6 months.
• Participation in any other therapeutic clinical trial in the previous 4 weeks

Where it is running

• Jefferson Associates in Internal Medicine,LTD — Clairton, Pennsylvania, United States

Full record on ClinicalTrials.gov

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