Trial Outcomes & Findings for A Study for the Assessment of the Benefits of a Novel Mesh Nebulizer in the Treatment of Patients With Stable COPD (NCT NCT03933462)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

60 days

Results posted on

2020-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	InnoSpire Go, Then Current Jet Nebulizer Participants first assigned to use the InnoSpire Go for nebulizer treatments for 30 days. Then they then were assigned to use their current jet nebulizer for nebulizer treatments for 30 days	Current Jet Nebulizer, Then Innospire Go Participants first assigned to use their current jet nebulizer for nebulizer treatments for 30 days. Then they then were assigned to use Innospire Go for nebulizer treatments for 30 days.
Overall Study STARTED	10	10
Overall Study Crossover	8	10
Overall Study COMPLETED	8	10
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	InnoSpire Go, Then Current Jet Nebulizer Participants first assigned to use the InnoSpire Go for nebulizer treatments for 30 days. Then they then were assigned to use their current jet nebulizer for nebulizer treatments for 30 days	Current Jet Nebulizer, Then Innospire Go Participants first assigned to use their current jet nebulizer for nebulizer treatments for 30 days. Then they then were assigned to use Innospire Go for nebulizer treatments for 30 days.
Overall Study Adverse Event	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=21 Participants All participants that signed a consent form.
Age, Continuous	65.9 years STANDARD_DEVIATION 6.8 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants
Body Mass Index(BMI)	27.8 kilograms/m^2 STANDARD_DEVIATION 6.8 • n=5 Participants

PRIMARY outcome

Timeframe: 60 days

Population: One participant removed from the data set because they were on the incorrect standard of care device.

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.

Outcome measures

Outcome measures
Measure	InnoSpire Go n=17 Participants 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. InnoSpire Go: Participants will use for 30 days.	Jet Nebulizer n=17 Participants 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. Jet Nebulizer: Participants will use for 30 days.
Device Preference Among the Number of Participants.	17 Participants	0 Participants

SECONDARY outcome

Timeframe: baseline and 30 days for each intervention

Population: One participant removed from the data set because they were on the incorrect standard of care device.

Change in quality of life scores (mean difference) 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)

Outcome measures

Outcome measures
Measure	InnoSpire Go n=17 Participants 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. InnoSpire Go: Participants will use for 30 days.	Jet Nebulizer n=17 Participants 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. Jet Nebulizer: Participants will use for 30 days.
Change in Quality of Life From Baseline on the CRQ-SR Emotional Function	0.6 mean difference of units on a scale Standard Deviation 1.5	0.1 mean difference of units on a scale Standard Deviation 1.5
Change in Quality of Life From Baseline on the CRQ-SR Dyspnea	1.2 mean difference of units on a scale Standard Deviation 2.1	0.8 mean difference of units on a scale Standard Deviation 2.1
Change in Quality of Life From Baseline on the CRQ-SR Fatigue	0.7 mean difference of units on a scale Standard Deviation 1.9	0.2 mean difference of units on a scale Standard Deviation 1.9
Change in Quality of Life From Baseline on the CRQ-SR Mastery	0.8 mean difference of units on a scale Standard Deviation 1.6	0.1 mean difference of units on a scale Standard Deviation 1.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days, 30 days

Population: One participant removed from the data set because they were on the incorrect standard of care device.

Difference in total distance walked as measured by a 6-Minute Walk Test (6MWT) between participants jet nebulizer and InnoSpire Go

Outcome measures

Outcome measures
Measure	InnoSpire Go n=17 Participants 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. InnoSpire Go: Participants will use for 30 days.	Jet Nebulizer n=17 Participants 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. Jet Nebulizer: Participants will use for 30 days.
Difference in Total Distance Walked as Measured by a 6-Minute Walk Test	278.7 meters Standard Deviation 111.0	275.7 meters Standard Deviation 125.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days, 30 days

Population: One participant removed from the data set because they were on the incorrect standard of care device.

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.

Outcome measures

Outcome measures
Measure	InnoSpire Go n=17 Participants 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. InnoSpire Go: Participants will use for 30 days.	Jet Nebulizer n=17 Participants 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. Jet Nebulizer: Participants will use for 30 days.
Change in Modified Borg Score Borg: 15 Min After Neb/Borg: Before Neb Use	-1.32 score on a scale Standard Deviation 0.86	-1.09 score on a scale Standard Deviation 0.48
Change in Modified Borg Score Borg: After 6MWT/Borg: 15 Min After Neb Use	6.38 score on a scale Standard Deviation 1.57	7.09 score on a scale Standard Deviation 1.38
Change in Modified Borg Score Borg: After 6MWT/Borg: Before Neb Use	5.06 score on a scale Standard Deviation 2.00	6.00 score on a scale Standard Deviation 1.25

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days, 30 days

Population: One participant removed from the data set because they were on the incorrect standard of care device.

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.

Outcome measures

Outcome measures
Measure	InnoSpire Go n=17 Participants 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. InnoSpire Go: Participants will use for 30 days.	Jet Nebulizer n=17 Participants 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. Jet Nebulizer: Participants will use for 30 days.
Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling Confidence with use	9.6 score on a scale Standard Deviation 0.8	7.9 score on a scale Standard Deviation 2.8
Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling Effect on shortness of breath	8.8 score on a scale Standard Deviation 1.7	6.9 score on a scale Standard Deviation 1.9
Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling Difficulty of assembly/disassembly	9.9 score on a scale Standard Deviation 0.5	7.1 score on a scale Standard Deviation 2.9
Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling Difficulty of Cleaning	9.6 score on a scale Standard Deviation 0.9	7.2 score on a scale Standard Deviation 2.9
Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling Overall usablity	9.4 score on a scale Standard Deviation 2.2	6.5 score on a scale Standard Deviation 2.9
Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling Overall Burden	9.6 score on a scale Standard Deviation 1.1	5.8 score on a scale Standard Deviation 3.1
Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling Confidence in medication delivery	9.8 score on a scale Standard Deviation 1.0	6.4 score on a scale Standard Deviation 3.1
Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling Overall Satisfaction	9.2 score on a scale Standard Deviation 2.4	5.9 score on a scale Standard Deviation 2.8
Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling Likelihood recomendation	9.9 score on a scale Standard Deviation 0.5	5.1 score on a scale Standard Deviation 3.2
Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling Fit with Lifestyle	9.8 score on a scale Standard Deviation 1.0	4.4 score on a scale Standard Deviation 2.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days, 30 days

Population: One participant did not have video data for InnospireGo and was excluded for the analysis.,

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)

Outcome measures

Outcome measures
Measure	InnoSpire Go n=16 Participants 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. InnoSpire Go: Participants will use for 30 days.	Jet Nebulizer n=16 Participants 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. Jet Nebulizer: Participants will use for 30 days.
Difference in Participant Use Time	5.0 minutes Standard Deviation 0.7	9.1 minutes Standard Deviation 5.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days, 30 days

Population: One participant removed from the data set because they were on the incorrect standard of care device.

Amount of fluid nebulized (pre- and post-weight of nebulizer) between each device

Outcome measures

Outcome measures
Measure	InnoSpire Go n=17 Participants 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. InnoSpire Go: Participants will use for 30 days.	Jet Nebulizer n=17 Participants 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. Jet Nebulizer: Participants will use for 30 days.
Amount of Fluid Nebulized	-2.4 grams Standard Deviation 0.3	-2.1 grams Standard Deviation 0.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days, 30 days

Population: Difficult to discern due to poor video quality.

Time spent using the device will be compared between each device. The following time will be analyzed: Time to fill (open disposable nebulizer, dispense ampule, close or reassemble)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days, 30 days

Population: Difficult to standardized as it is difficult to hear and observed aerosol mist with the different jet nebulizers

Time spent using the device will be compared between each device. The following time will be analyzed: Time to sputter.

Outcome measures

Outcome data not reported

Adverse Events

InnoSpire Go

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Jet Nebulizer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	InnoSpire Go n=21 participants at risk Participants first assigned to use the InnoSpire Go for nebulizer treatments for 30 days.	Jet Nebulizer n=21 participants at risk Participants first assigned to use their current jet nebulizer for nebulizer treatments for 30 days.
Respiratory, thoracic and mediastinal disorders COPD Exacerbation	9.5% 2/21 • Number of events 2 • 60 days	0.00% 0/21 • 60 days

Other adverse events

Other adverse events
Measure	InnoSpire Go n=21 participants at risk Participants first assigned to use the InnoSpire Go for nebulizer treatments for 30 days.	Jet Nebulizer n=21 participants at risk Participants first assigned to use their current jet nebulizer for nebulizer treatments for 30 days.
Nervous system disorders Migraine	4.8% 1/21 • Number of events 1 • 60 days	0.00% 0/21 • 60 days

Additional Information

Sara Garbin

Philips

Phone: 724-787-8550

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place