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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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COPD

Intervention / Treatment
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* Device: InnoSpire Go
* Device: Jet Nebulizer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 40 years of age. Diagnosis of COPD. Currently using only a mouthpiece with their nebulizer system. Forced Expiratory Volume at 1 second (FEV1) ≥ 30% predicted (pre or post bronchodilator). Modified Medical Research Council (mMRC) Dyspnea scale grade ≥ 1. Use of a jet nebulizer for the administration of albuterol or combination albuterol/ipratropium for the past 6 months Willing to use the same compressor/nebulizer system throughout the study Willing to refrain from using the jet nebulizer system when using InnoSpire Go 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. Willing to permit audio and video recording during the visit. Willing and able to follow instructions and complete all activities required by the trial, including phone calls. Able to read and understand English. Exclusion Criteria: Unable to complete 6MWT or, if patient is not currently prescribed oxygen, persistent oxygen desaturation ≤ 88% on the 6MWT. Exacerbation of COPD requiring hospitalization in the last 3 months (defined as hospital admission, urgent care visit, or emergency room visit). Prescribed non-selective beta blockers. Prescribed additional ipratropium bromide via nebulizer or inhaler or any other nebulized treatments via the subject's jet nebulizer. Patients currently in assisted living or nursing home. 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. History of thoracotomy. Myocardial infarction within the last 6 months. Participation in any other therapeutic clinical trial in the previous 4 weeks

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: InnoSpire Go<br>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<br>* Participants will use for 30 days.<br>|
| Active Comparator: Jet Nebulizer<br>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<br>* Participants will use for 30 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | baseline and 30 days for each intervention |