Clinical trial NCT03933462: A Study for the Assessment of the Benefits of a Novel Mesh Nebulizer in the Treatment of Patients With Stable COPD
Official title: A Study for the Assessment of the Benefits of a Novel Mesh Nebulizer in the Treatment of Patients With Stable COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2019-05-01
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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 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

Primary outcomes:
measure: Device Preference Among the Number of Participants.
timeFrame: 60 days
Secondary outcomes:
measure: Change in Quality of Life From Baseline on the CRQ-SR
timeFrame: baseline and 30 days for each intervention
Other outcomes:
measure: Difference in Total Distance Walked as Measured by a 6-Minute Walk Test
timeFrame: 30 days, 30 days
measure: Change in Modified Borg Score
timeFrame: 30 days, 30 days
measure: Participant Satisfaction Based on Specific Elements of the Device's Operation and Handling
timeFrame: 30 days, 30 days
measure: Difference in Participant Use Time
timeFrame: 30 days, 30 days
measure: Amount of Fluid Nebulized
timeFrame: 30 days, 30 days
measure: Difference in Participant Time to Fill
timeFrame: 30 days, 30 days
measure: Difference in Participant Time to Sputter
timeFrame: 30 days, 30 days
Locations:
city: Clairton
country: United States
facility: Jefferson Associates in Internal Medicine,LTD
state: Pennsylvania
Study officials:
References:
citation: 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.