N/A
Completed N=20
A Study for the Assessment of the Benefits of a Novel Mesh Nebulizer in the Treatment of Patients With Stable COPD
Source: ClinicalTrials.gov NCT03933462 ↗Enrolled (actual)
20
Serious AEs
4.8%
Results posted
Dec 2020
Primary outcomePrimary: Device Preference Among the Number of Participants. — 17; 0 Participants — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Device Preference Among the Number of Participants. |
17; 0 | <0.001 sig |
| SECONDARY Change in Quality of Life From Baseline on the CRQ-SR |
1.2; 0.8; 0.7; 0.2; 0.6; 0.1 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03933462). 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.