COPDNCT03933462
A Study for the Assessment of the Benefits of a Novel Mesh Nebulizer in the Treatment of Patients With Stable COPD
A study testing InnoSpire Go and Jet Nebulizer in people with COPD, run by Philips Respironics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- InnoSpire Go and Jet Nebulizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2019to 28 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- History of thoracotomy.
- Myocardial infarction within the last 6 months.
- Participation in any other therapeutic clinical trial in the previous 4 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson Associates in Internal Medicine,LTD
Clairton, Pennsylvania, 15025
About this study
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.
Read the 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.
- Conditions
- COPD
- Being tested
- InnoSpire Go, Jet Nebulizer
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InnoSpire GoDevice
Participants will use for 30 days.
Jet NebulizerDevice
Participants will use for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| InnoSpire Go | Experimental | 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. Receives: Device: InnoSpire Go |
| Jet Nebulizer | Active comparator | 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. Receives: Device: Jet Nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 days
Secondary outcomes (1)
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)
Measured: baseline and 30 days for each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start12 Jun 2019
- Primary completion28 Oct 2019
- Study completion28 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933462
- Sponsor's protocol ID
- SRC-RDD-InnospireGo-2018-10458
- Status last verified
- Nov 2020
- First submitted
- 12 Apr 2019
- Last updated
- 17 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 35196114
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study for the Assessment of the Benefits of a Novel Mesh Nebulizer in the Treatment of Patients With Stable COPD
- ClinicalTrials.gov ID
- NCT03933462
- Acronym / sponsor ID
- SRC-RDD-InnospireGo-2018-10458
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 28 Oct 2019 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Posted 17 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| InnoSpire Go | Experimental | Device: InnoSpire GoThe 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. |
| Jet Nebulizer | Active comparator | Device: Jet NebulizerJet 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InnoSpire GoParticipants will use for 30 days. | Device | InnoSpire Go |
| Jet NebulizerParticipants will use for 30 days. | Device | Jet Nebulizer |
Primary outcome
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.
1 secondary outcome
Change in Quality of Life From Baseline on the CRQ-SR
Time frame: baseline and 30 days for each intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35196114Nickerson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InnoSpire Go and Jet Nebulizer in people with COPD, run by Philips Respironics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Preference Among the Number of Participants. (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03933462, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.