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

• Sponsor: Philips Respironics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03933462
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.5
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD	Device: InnoSpire Go; Device: Jet Nebulizer	N/A

Detailed Description

Participants will be contacted by designated study site staff. Participants may be pre-screened through medical records over the phone to assess potential eligibility. A screening script will include a general review of key inclusion and exclusion criteria. Participants that are interested will be scheduled for a screening visit at the clinical office.

Visit 1 - Screening/Baseline:

Once the participant arrives, the study will be explained in full detail. If the participant agrees, he/she will be consented into the study and the participant will be given a copy of the informed consent. After the consent is signed, the following procedures will be performed:

Demographics

Medical History

Concomitant Medication

mMRC

Chronic Respiratory Disease Questionnaire (CRQ) Self-Reported (SR)

Pulmonary Function Tests

Vital Signs prior to 6 Minute Walk (6MW)

6-Minute Walk Test (6MWT)

Modified Borg Assessment

Inclusion/Exclusion Criteria Review

Device Photograph

Randomization Participants will be randomly assigned to either their current jet nebulizer or the InnoSpire Go device for the first 30 days of treatment.

Training Session Participants randomized to InnoSpire Go in the first treatment arm will be trained on the use and cleaning of the device before being sent home.

Visit 2 - Interim Visit:

Participants will be asked to return to the research center 15 days ± 3 days after Visit 1.

Side Effect and Adverse Event Assessment Participants will be asked about any side effects or adverse events (AEs) since the last visit.

Concomitant Medications

CRQ-SR (Follow-Up)

Nebulizer Satisfaction Assessment Participant satisfaction with the device used in the first treatment arm will be assessed.

Visit 3 - Cross-over:

Participants will be asked to return to the research center within 30 days ± 3 days after Visit 1. They will be instructed to bring the first assigned study device and their prescribed albuterol or combination albuterol/ipratropium medication for the demonstration.

CRQ-SR (Follow-Up)

Concomitant Medications

Device Use Demonstration

Nebulizer Weight The nebulizer cup/reservoir alone will be weighed with the medication before device use and after device use to capture residual medication. This process will take place during video recording.

Peak inspiratory flow (PIF)

Vital Signs prior to 6MW

. Modified Borg Assessment

6-Minute Walk Test

Nebulizer Satisfaction Assessment Participant satisfaction with the device used in the first treatment arm will be assessed.

Training Session Participants randomized to InnoSpire Go in the second treatment arm will be trained on the use and cleaning of the device before being sent home.

Visit 4 - Interim Visit:

Participants will be asked to return to the research center 15 days ± 3 days after Visit 3. Participants will complete procedures outlined in Visit 2.

Visit 5 -Final Visit:

Participants will return to the clinical facility 30 days (± 3 days) after Visit 3 completion. They will be instructed to bring the second assigned study device and their prescribed albuterol or combination albuterol/ipratropium medication for the demonstration. Participants will complete the procedures outlined in Visit 3. Participants will need to return all study equipment at this visit.

Participants will be discharged from the study following completion of study procedures.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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: Jun 12, 2019
• Actual Primary Completion Date: Oct 28, 2019
• Actual Study Completion Date: Oct 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Device Preference Among the Number of Participants. [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.

Secondary Outcome Measures

1. Change in Quality of Life From Baseline on the CRQ-SR [baseline and 30 days for each intervention]

   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)

Other Outcome Measures

1. Difference in Total Distance Walked as Measured by a 6-Minute Walk Test [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

2. Change in Modified Borg Score [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.

3. Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling [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.

4. Difference in Participant Use Time [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)

5. Amount of Fluid Nebulized [30 days, 30 days]

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

6. Difference in Participant Time to Fill [30 days, 30 days]

   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)

7. Difference in Participant Time to Sputter [30 days, 30 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients ≥ 40 years of age.

2. Diagnosis of COPD.

3. Currently using only a mouthpiece with their nebulizer system.

4. Forced Expiratory Volume at 1 second (FEV1) ≥ 30% predicted (pre or post bronchodilator).

5. Modified Medical Research Council (mMRC) Dyspnea scale grade ≥ 1.

6. Use of a jet nebulizer for the administration of albuterol or combination albuterol/ipratropium for the past 6 months

7. Willing to use the same compressor/nebulizer system throughout the study

8. Willing to refrain from using the jet nebulizer system when using InnoSpire Go

9. 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.

10. Willing to permit audio and video recording during the visit.

11. Willing and able to follow instructions and complete all activities required by the trial, including phone calls.

12. Able to read and understand English.

Exclusion Criteria:

1. Unable to complete 6MWT or, if patient is not currently prescribed oxygen, persistent oxygen desaturation ≤ 88% on the 6MWT.

2. Exacerbation of COPD requiring hospitalization in the last 3 months (defined as hospital admission, urgent care visit, or emergency room visit).

3. Prescribed non-selective beta blockers.

4. Prescribed additional ipratropium bromide via nebulizer or inhaler or any other nebulized treatments via the subject's jet nebulizer.

5. Patients currently in assisted living or nursing home.

6. 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.

7. History of thoracotomy.

8. Myocardial infarction within the last 6 months.

9. Participation in any other therapeutic clinical trial in the previous 4 weeks

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jefferson Associates in Internal Medicine,LTD	Clairton	Pennsylvania	United States	15025

Sponsors and Collaborators

• Philips Respironics

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 7, 2019

More Information

Publications

None provided.

• Responsible Party: Philips Respironics
• ClinicalTrials.gov Identifier: NCT03933462
• Other Study ID Numbers: SRC-RDD-InnospireGo-2018-10458
• First Posted: May 1, 2019
• Last Update Posted: Dec 17, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

Participant Flow

Arm/Group Title	InnoSpire Go, Then Current Jet Nebulizer	Current Jet Nebulizer, Then Innospire Go
Arm/Group Description	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	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.
Period Title: Overall Study
STARTED	10	10
Crossover	8	10
COMPLETED	8	10
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	All participants that signed a consent form.
Overall Participants	21
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.9 (6.8)
Sex: Female, Male (Count of Participants)
Female	16 76.2%
Male	5 23.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	21 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 4.8%
White	20 95.2%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	21 100%
Body Mass Index(BMI) (kilograms/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms/m^2]	27.8 (6.8)

Outcome Measures

1. Primary Outcome

Title	Device Preference Among the Number of Participants.
Description	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.
Time Frame	60 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	InnoSpire Go	Jet Nebulizer
Arm/Group Description	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 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.
Measure Participants	17	17
Count of Participants [Participants]	17 81%	0 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	InnoSpire Go, Jet Nebulizer
	Comments
	Type of Statistical Test	Superiority
	Comments	Categorical preference endpoints that answered at the final visit (e.g., "Which device do you prefer?") were analyzed with a One-sample Binomial Test that compared the observed proportion to a 50/50 split.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	One Sample Binomial
	Comments

2. Secondary Outcome

Title	Change in Quality of Life From Baseline on the CRQ-SR
Description	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)
Time Frame	baseline and 30 days for each intervention

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	InnoSpire Go	Jet Nebulizer
Arm/Group Description	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 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.
Measure Participants	17	17
Dyspnea	1.2 (2.1)	0.8 (2.1)
Fatigue	0.7 (1.9)	0.2 (1.9)
Emotional Function	0.6 (1.5)	0.1 (1.5)
Mastery	0.8 (1.6)	0.1 (1.6)

3. Other Pre-specified Outcome

Title	Difference in Total Distance Walked as Measured by a 6-Minute Walk Test
Description	Difference in total distance walked as measured by a 6-Minute Walk Test (6MWT) between participants jet nebulizer and InnoSpire Go
Time Frame	30 days, 30 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	InnoSpire Go	Jet Nebulizer
Arm/Group Description	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 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.
Measure Participants	17	17
Mean (Standard Deviation) [meters]	278.7 (111.0)	275.7 (125.6)

4. Other Pre-specified Outcome

Title	Change in Modified Borg Score
Description	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.
Time Frame	30 days, 30 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	InnoSpire Go	Jet Nebulizer
Arm/Group Description	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 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.
Measure Participants	17	17
Borg: 15 Min After Neb/Borg: Before Neb Use	-1.32 (0.86)	-1.09 (0.48)
Borg: After 6MWT/Borg: 15 Min After Neb Use	6.38 (1.57)	7.09 (1.38)
Borg: After 6MWT/Borg: Before Neb Use	5.06 (2.00)	6.00 (1.25)

5. Other Pre-specified Outcome

Title	Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling
Description	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.
Time Frame	30 days, 30 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	InnoSpire Go	Jet Nebulizer
Arm/Group Description	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 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.
Measure Participants	17	17
Confidence with use	9.6 (0.8)	7.9 (2.8)
Effect on shortness of breath	8.8 (1.7)	6.9 (1.9)
Difficulty of assembly/disassembly	9.9 (0.5)	7.1 (2.9)
Difficulty of Cleaning	9.6 (0.9)	7.2 (2.9)
Overall usablity	9.4 (2.2)	6.5 (2.9)
Overall Burden	9.6 (1.1)	5.8 (3.1)
Confidence in medication delivery	9.8 (1.0)	6.4 (3.1)
Overall Satisfaction	9.2 (2.4)	5.9 (2.8)
Likelihood recomendation	9.9 (0.5)	5.1 (3.2)
Fit with Lifestyle	9.8 (1.0)	4.4 (2.7)

6. Other Pre-specified Outcome

Title	Difference in Participant Use Time
Description	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 Frame	30 days, 30 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	InnoSpire Go	Jet Nebulizer
Arm/Group Description	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 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.
Measure Participants	16	16
Mean (Standard Deviation) [minutes]	5.0 (0.7)	9.1 (5.8)

7. Other Pre-specified Outcome

Title	Amount of Fluid Nebulized
Description	Amount of fluid nebulized (pre- and post-weight of nebulizer) between each device
Time Frame	30 days, 30 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	InnoSpire Go	Jet Nebulizer
Arm/Group Description	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 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.
Measure Participants	17	17
Mean (Standard Deviation) [grams]	-2.4 (0.3)	-2.1 (0.7)

8. Other Pre-specified Outcome

Title	Difference in Participant Time to Fill
Description	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)
Time Frame	30 days, 30 days

Outcome Measure Data

Analysis Population Description

Difficult to discern due to poor video quality.

Arm/Group Title	InnoSpire Go	Jet Nebulizer
Arm/Group Description	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 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.
Measure Participants	0	0

9. Other Pre-specified Outcome

Title	Difference in Participant Time to Sputter
Description	Time spent using the device will be compared between each device. The following time will be analyzed: Time to sputter.
Time Frame	30 days, 30 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	InnoSpire Go	Jet Nebulizer
Arm/Group Description	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 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.
Measure Participants	0	0

Adverse Events

Time Frame	60 days
Arm/Group Title	InnoSpire Go		Jet Nebulizer
Arm/Group Description	Participants first assigned to use the InnoSpire Go for nebulizer treatments for 30 days.		Participants first assigned to use their current jet nebulizer for nebulizer treatments for 30 days.
All Cause Mortality
	InnoSpire Go		Jet Nebulizer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/21 (0%)
Serious Adverse Events
	InnoSpire Go		Jet Nebulizer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/21 (9.5%)		0/21 (0%)
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation	2/21 (9.5%)	2	0/21 (0%)	0
Other (Not Including Serious) Adverse Events
	InnoSpire Go		Jet Nebulizer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/21 (4.8%)		0/21 (0%)
Nervous system disorders
Migraine	1/21 (4.8%)	1	0/21 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.