COPD
Conditions
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.
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.
Interventions
DEVICEInnoSpire Go
Participants will use for 30 days.
DEVICEJet Nebulizer
Participants will use for 30 days.
Sponsors
Philips Respironics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
| 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 |
| 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) |
| 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. |
| Amount of Fluid Nebulized | 30 days, 30 days | Amount of fluid nebulized (pre- and post-weight of nebulizer) between each device |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants that signed a consent form. | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 65.9 years STANDARD_DEVIATION 6.8 |
| Body Mass Index(BMI) | 27.8 kilograms/m^2 STANDARD_DEVIATION 6.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 1 / 21 | 0 / 21 |
| serious Total, serious adverse events | 2 / 21 | 0 / 21 |
Outcome results
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.
Time frame: 60 days
Population: One participant removed from the data set because they were on the incorrect standard of care device.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| InnoSpire Go | Device Preference Among the Number of Participants. | 17 Participants |
| Jet Nebulizer | Device Preference Among the Number of Participants. | 0 Participants |
p-value: <0.001One Sample Binomial
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)
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| InnoSpire Go | 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 |
| InnoSpire Go | 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 |
| InnoSpire Go | 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 |
| InnoSpire Go | 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 |
| Jet Nebulizer | Change in Quality of Life From Baseline on the CRQ-SR | Mastery | 0.1 mean difference of units on a scale | Standard Deviation 1.6 |
| Jet Nebulizer | Change in Quality of Life From Baseline on the CRQ-SR | Dyspnea | 0.8 mean difference of units on a scale | Standard Deviation 2.1 |
| Jet Nebulizer | Change in Quality of Life From Baseline on the CRQ-SR | Emotional Function | 0.1 mean difference of units on a scale | Standard Deviation 1.5 |
| Jet Nebulizer | Change in Quality of Life From Baseline on the CRQ-SR | Fatigue | 0.2 mean difference of units on a scale | Standard Deviation 1.9 |
Other Pre-specified
Amount of Fluid Nebulized
Amount of fluid nebulized (pre- and post-weight of nebulizer) between each device
Time frame: 30 days, 30 days
Population: One participant removed from the data set because they were on the incorrect standard of care device.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| InnoSpire Go | Amount of Fluid Nebulized | -2.4 grams | Standard Deviation 0.3 |
| Jet Nebulizer | Amount of Fluid Nebulized | -2.1 grams | Standard Deviation 0.7 |
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.
Time frame: 30 days, 30 days
Population: One participant removed from the data set because they were on the incorrect standard of care device.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| InnoSpire Go | Change in Modified Borg Score | Borg: 15 Min After Neb/Borg: Before Neb Use | -1.32 score on a scale | Standard Deviation 0.86 |
| InnoSpire Go | Change in Modified Borg Score | Borg: After 6MWT/Borg: 15 Min After Neb Use | 6.38 score on a scale | Standard Deviation 1.57 |
| InnoSpire Go | Change in Modified Borg Score | Borg: After 6MWT/Borg: Before Neb Use | 5.06 score on a scale | Standard Deviation 2 |
| Jet Nebulizer | Change in Modified Borg Score | Borg: 15 Min After Neb/Borg: Before Neb Use | -1.09 score on a scale | Standard Deviation 0.48 |
| Jet Nebulizer | Change in Modified Borg Score | Borg: After 6MWT/Borg: 15 Min After Neb Use | 7.09 score on a scale | Standard Deviation 1.38 |
| Jet Nebulizer | Change in Modified Borg Score | Borg: After 6MWT/Borg: Before Neb Use | 6.00 score on a scale | Standard Deviation 1.25 |
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)
Time frame: 30 days, 30 days
Population: Difficult to discern due to poor video quality.
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.
Time frame: 30 days, 30 days
Population: Difficult to standardized as it is difficult to hear and observed aerosol mist with the different jet nebulizers
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)
Time frame: 30 days, 30 days
Population: One participant did not have video data for InnospireGo and was excluded for the analysis.,
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| InnoSpire Go | Difference in Participant Use Time | 5.0 minutes | Standard Deviation 0.7 |
| Jet Nebulizer | Difference in Participant Use Time | 9.1 minutes | Standard Deviation 5.8 |
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
Time frame: 30 days, 30 days
Population: One participant removed from the data set because they were on the incorrect standard of care device.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| InnoSpire Go | Difference in Total Distance Walked as Measured by a 6-Minute Walk Test | 278.7 meters | Standard Deviation 111 |
| Jet Nebulizer | Difference in Total Distance Walked as Measured by a 6-Minute Walk Test | 275.7 meters | Standard Deviation 125.6 |
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.
Time frame: 30 days, 30 days
Population: One participant removed from the data set because they were on the incorrect standard of care device.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| InnoSpire Go | 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 |
| InnoSpire Go | 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 |
| InnoSpire Go | 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 |
| InnoSpire Go | 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 |
| InnoSpire Go | 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 |
| InnoSpire Go | 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 |
| InnoSpire Go | 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 |
| InnoSpire Go | 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 |
| InnoSpire Go | 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 |
| InnoSpire Go | 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 |
| Jet Nebulizer | Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling | Overall Satisfaction | 5.9 score on a scale | Standard Deviation 2.8 |
| Jet Nebulizer | Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling | Confidence with use | 7.9 score on a scale | Standard Deviation 2.8 |
| Jet Nebulizer | Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling | Overall Burden | 5.8 score on a scale | Standard Deviation 3.1 |
| Jet Nebulizer | Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling | Effect on shortness of breath | 6.9 score on a scale | Standard Deviation 1.9 |
| Jet Nebulizer | Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling | Fit with Lifestyle | 4.4 score on a scale | Standard Deviation 2.7 |
| Jet Nebulizer | Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling | Difficulty of assembly/disassembly | 7.1 score on a scale | Standard Deviation 2.9 |
| Jet Nebulizer | Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling | Confidence in medication delivery | 6.4 score on a scale | Standard Deviation 3.1 |
| Jet Nebulizer | Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling | Difficulty of Cleaning | 7.2 score on a scale | Standard Deviation 2.9 |
| Jet Nebulizer | Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling | Likelihood recomendation | 5.1 score on a scale | Standard Deviation 3.2 |
| Jet Nebulizer | Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling | Overall usablity | 6.5 score on a scale | Standard Deviation 2.9 |