A Study for the Assessment of the Benefits of a Novel Mesh Nebulizer in the Treatment of Patients With Stable COPD
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|ClinicalTrials.gov Identifier: NCT03933462|
Recruitment Status : Active, not recruiting
First Posted : May 1, 2019
Last Update Posted : October 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|COPD||Device: InnoSpire Go Device: Jet Nebulizer||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study for the Assessment of the Benefits of a Novel Mesh Nebulizer in the Treatment of Patients With Stable COPD|
|Actual Study Start Date :||June 12, 2019|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
Experimental: InnoSpire Go
The 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.
Device: InnoSpire Go
Participants will use for 30 days.
Active Comparator: Jet Nebulizer
Jet 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.
Device: Jet Nebulizer
Participants will use for 30 days.
- Difference in overall device preference [ Time Frame: 60 days ]
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.
- Change in quality of life from baseline on the CRQ-SR [ Time Frame: 30 days, 30 days ]Change in quality of life scores after 30 days of each device use compared to baseline as determined by the Chronic Respiratory disease Questionnaire - Self-Report (CRQ-SR). The scores for each question in each dimension are simply added together. Using a seven-point scale for the responses, the minimum and maximum scores for each dimension are as follows: Minimum score Maximum score (Worst function is 1) (Best function is 7)
- Difference in total distance walked as measured by a 6-Minute Walk Test [ Time Frame: 30 days, 30 days ]Difference in total distance walked as measured by a 6-Minute Walk Test (6MWT) between participants jet nebulizer and InnoSpire Go
- Change in modified Borg score [ Time Frame: 30 days, 30 days ]The change in the modified Borg score following 6MWT, where the visit's post-nebulizer Borg score will be used as the baseline for this endpoint. The change in the modified Borg score following nebulizer use, where the visit's pre-nebulizer Borg score will be used as the baseline for this endpoint. Difference in modified Borg score from pre-nebulizer to post-6MWT for each device. This is a scale that asks you to rate the difficulty of your breathing. It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal.
- Participant satisfaction based on specific elements of the device's operation and handling [ Time Frame: 30 days, 30 days ]Difference in device confidence, perceived effect, difficulty of device assembly/disassembly, difficulty of cleaning and regular care, overall ease of handling or usability, overall burden, medication delivery confidence, overall satisfaction, likelihood of recommending, perception of with lifestyle and average ease of use score after each 30 days of device use. This assessment is a 10 question survey were respondents answer questions on a scale 0 to 10 with 0 being the worse and 10 being the best. Each question has a score of 0 to 10.
- Difference in participant set up and use time [ Time Frame: 30 days, 30 days ]
Time spent using the device will be compared between each device. The following times will be analyzed:
Time in mouth (treatment time = first insert of mouthpiece to last removal of mouthpiece), Time to fill (open disposable nebulizer, dispense ampule, close or reassemble), and time to sputter.
- Amount of fluid nebulized [ Time Frame: 30 days, 30 days ]Amount of fluid nebulized (pre- and post-weight of nebulizer) between each device
- Incidence of safety events ((USADEs) and (SAEs) [ Time Frame: 30 days, 30 days ]Incidence of Unanticipated Serious Adverse Device Effects (USADEs) and Serious Adverse Events (SAEs) with each device
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933462
|United States, Pennsylvania|
|Jefferson Associates in Internal Medicine,LTD|
|Clairton, Pennsylvania, United States, 15025|