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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| InnoSpire Go | Experimental | 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. |
|
| Jet Nebulizer | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InnoSpire Go | Device | Participants will use for 30 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life From Baseline on the CRQ-SR | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Total Distance Walked as Measured by a 6-Minute Walk Test | Difference in total distance walked as measured by a 6-Minute Walk Test (6MWT) between participants jet nebulizer and InnoSpire Go | 30 days, 30 days |
| Change in Modified Borg Score |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jefferson Associates in Internal Medicine,LTD | Clairton | Pennsylvania | 15025 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35196114 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants that signed a consent form. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One participant removed from the data set because they were on the incorrect standard of care device. | Posted | Count of Participants | Participants | 60 days |
|
60 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | InnoSpire Go | Participants first assigned to use the InnoSpire Go for nebulizer treatments for 30 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Migraine | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara Garbin | Philips | 724-787-8550 | sara.garbin@philips.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 7, 2019 | Sep 21, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Jet Nebulizer |
| Device |
Participants will use for 30 days. |
|
| baseline and 30 days for each intervention |
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.
| 30 days, 30 days |
| Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling | 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. | 30 days, 30 days |
| Difference in Participant Use Time | 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) | 30 days, 30 days |
| Amount of Fluid Nebulized | Amount of fluid nebulized (pre- and post-weight of nebulizer) between each device | 30 days, 30 days |
| Difference in Participant Time to Fill | 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) | 30 days, 30 days |
| Difference in Participant Time to Sputter | Time spent using the device will be compared between each device. The following time will be analyzed: Time to sputter. | 30 days, 30 days |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index(BMI) | Mean | Standard Deviation | kilograms/m^2 |
|
| OG001 | 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. Jet Nebulizer: Participants will use for 30 days. |
|
|
|
| Secondary | Change in Quality of Life From Baseline on the CRQ-SR | 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) | One participant removed from the data set because they were on the incorrect standard of care device. | Posted | Mean | Standard Deviation | mean difference of units on a scale | baseline and 30 days for each intervention |
|
|
|
| Other Pre-specified | Difference in Total Distance Walked as Measured by a 6-Minute Walk Test | Difference in total distance walked as measured by a 6-Minute Walk Test (6MWT) between participants jet nebulizer and InnoSpire Go | One participant removed from the data set because they were on the incorrect standard of care device. | Posted | Mean | Standard Deviation | meters | 30 days, 30 days |
|
|
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| Other Pre-specified | Change in Modified Borg Score | 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. | One participant removed from the data set because they were on the incorrect standard of care device. | Posted | Mean | Standard Deviation | score on a scale | 30 days, 30 days |
|
|
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| Other Pre-specified | Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling | 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. | One participant removed from the data set because they were on the incorrect standard of care device. | Posted | Mean | Standard Deviation | score on a scale | 30 days, 30 days |
|
|
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| Other Pre-specified | Difference in Participant Use Time | 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) | One participant did not have video data for InnospireGo and was excluded for the analysis., | Posted | Mean | Standard Deviation | minutes | 30 days, 30 days |
|
|
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| Other Pre-specified | Amount of Fluid Nebulized | Amount of fluid nebulized (pre- and post-weight of nebulizer) between each device | One participant removed from the data set because they were on the incorrect standard of care device. | Posted | Mean | Standard Deviation | grams | 30 days, 30 days |
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|
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| Other Pre-specified | Difference in Participant Time to Fill | 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) | Difficult to discern due to poor video quality. | Posted | 30 days, 30 days |
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| Other Pre-specified | Difference in Participant Time to Sputter | Time spent using the device will be compared between each device. The following time will be analyzed: Time to sputter. | Difficult to standardized as it is difficult to hear and observed aerosol mist with the different jet nebulizers | Posted | 30 days, 30 days |
|
|
| 0 |
| 21 |
| 2 |
| 21 |
| 1 |
| 21 |
| EG001 | Jet Nebulizer | Participants first assigned to use their current jet nebulizer for nebulizer treatments for 30 days. | 0 | 21 | 0 | 21 | 0 | 21 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Emotional Function |
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| Mastery |
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| Borg: After 6MWT/Borg: Before Neb Use |
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| Difficulty of assembly/disassembly |
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| Difficulty of Cleaning |
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| Overall usablity |
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| Overall Burden |
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| Confidence in medication delivery |
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| Overall Satisfaction |
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| Likelihood recomendation |
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| Fit with Lifestyle |
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