A Study for the Assessment of the Benefits of a Novel Mesh Nebulizer in the Treatment of Patients With Stable COPD
1 other identifier
interventional
21
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2019
CompletedFirst Posted
Study publicly available on registry
May 1, 2019
CompletedStudy Start
First participant enrolled
June 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2019
CompletedResults Posted
Study results publicly available
December 17, 2020
CompletedDecember 17, 2020
November 1, 2020
5 months
April 12, 2019
September 21, 2020
November 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Device Preference Among the Number of Participants.
Device preference after 60 days of device use as determined by the nebulizer satisfaction questionnaire in stable ambulatory Chronic Obstructive Pulmonary Disease (COPD) patients. The nebulizer satisfaction questionnaire is an 11 question survey developed to determine device satisfaction. 10 questions are answered on a scale of 0 to 10 with 0 being the worst and 10 being the best. The last question in the survey is in regards to device preference and is only asked at the end of the study.
60 days
Secondary Outcomes (1)
Change in Quality of Life From Baseline on the CRQ-SR
baseline and 30 days for each intervention
Other Outcomes (7)
Difference in Total Distance Walked as Measured by a 6-Minute Walk Test
30 days, 30 days
Change in Modified Borg Score
30 days, 30 days
Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling
30 days, 30 days
- +4 more other outcomes
Study Arms (2)
InnoSpire Go
EXPERIMENTALThe InnoSpire Go is a handheld, single patient use, vibrating mesh nebulizer system designed to aerosolize liquid medications for respiratory disease. The device operates continuously once initiated and automatically switches off once the medication has been delivered. The device may be used in pediatric and adult populations, as permitted by the prescribed medication, and is suitable for use in home environments or hospital/clinic settings.
Jet Nebulizer
ACTIVE COMPARATORJet Nebulizers are the standard delivery system for aerosolized medications. A nebulizer breaks up medical solutions into small droplets suspended in air (aerosol) so that they may be delivered to the patient's airways for respiratory therapy.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jefferson Associates in Internal Medicine,LTD
Clairton, Pennsylvania, 15025, United States
Related Publications (1)
Nickerson C, Hollen DV, Garbin S, Doty K, Jasko J, Cain C. Pilot Study to Investigate the Benefits of the InnoSpire Go Mesh Nebulizer Compared to Jet Nebulizers in the Treatment of Stable COPD. J Aerosol Med Pulm Drug Deliv. 2022 Aug;35(4):186-195. doi: 10.1089/jamp.2021.0054. Epub 2022 Feb 23.
PMID: 35196114DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sara Garbin
- Organization
- Philips
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2019
First Posted
May 1, 2019
Study Start
June 12, 2019
Primary Completion
October 28, 2019
Study Completion
October 28, 2019
Last Updated
December 17, 2020
Results First Posted
December 17, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share