- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03933462
A Study for the Assessment of the Benefits of a Novel Mesh Nebulizer in the Treatment of Patients With Stable COPD
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Clairton, Pennsylvania, United States, 15025
- Jefferson Associates in Internal Medicine,LTD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / 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.
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Participants will use for 30 days.
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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.
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Participants will use for 30 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Device Preference Among the Number of Participants.
Time Frame: 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. |
60 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Quality of Life From Baseline on the CRQ-SR
Time Frame: baseline and 30 days for each intervention
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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)
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baseline and 30 days for each intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Total Distance Walked as Measured by a 6-Minute Walk Test
Time Frame: 30 days, 30 days
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Difference in total distance walked as measured by a 6-Minute Walk Test (6MWT) between participants jet nebulizer and InnoSpire Go
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30 days, 30 days
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Change in Modified Borg Score
Time Frame: 30 days, 30 days
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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.
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30 days, 30 days
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Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling
Time Frame: 30 days, 30 days
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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.
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30 days, 30 days
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Difference in Participant Use Time
Time Frame: 30 days, 30 days
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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
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Amount of Fluid Nebulized
Time Frame: 30 days, 30 days
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Amount of fluid nebulized (pre- and post-weight of nebulizer) between each device
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30 days, 30 days
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Difference in Participant Time to Fill
Time Frame: 30 days, 30 days
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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
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Difference in Participant Time to Sputter
Time Frame: 30 days, 30 days
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Time spent using the device will be compared between each device. The following time will be analyzed: Time to sputter. |
30 days, 30 days
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SRC-RDD-InnospireGo-2018-10458
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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