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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

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ClinicalTrials.gov Identifier: NCT03933462
Recruitment Status : Active, not recruiting
First Posted : May 1, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Philips Respironics

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 Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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 : June 12, 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

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.




Primary Outcome Measures :
  1. Difference in overall device preference [ 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.



Secondary Outcome Measures :
  1. Change in quality of life from baseline on the CRQ-SR [ Time Frame: 30 days, 30 days ]
    Change in quality of life scores 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 set up and use time [ Time Frame: 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), Time to fill (open disposable nebulizer, dispense ampule, close or reassemble), and time to sputter.


  5. Amount of fluid nebulized [ Time Frame: 30 days, 30 days ]
    Amount of fluid nebulized (pre- and post-weight of nebulizer) between each device

  6. Incidence of safety events ((USADEs) and (SAEs) [ Time Frame: 30 days, 30 days ]
    Incidence of Unanticipated Serious Adverse Device Effects (USADEs) and Serious Adverse Events (SAEs) with each device



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 nebuilizer 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933462


Locations
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United States, Pennsylvania
Jefferson Associates in Internal Medicine,LTD
Clairton, Pennsylvania, United States, 15025
Sponsors and Collaborators
Philips Respironics

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Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT03933462     History of Changes
Other Study ID Numbers: SRC-RDD-InnospireGo-2018-10458
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No