免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / A Study for the Assessment of the Benefits of a Novel Mesh Nebulizer in the Treatment of Patients With Stable COPD
A Study for the Assessment of the Benefits of a Novel Mesh Nebulizer in the Treatment of Patients With Stable COPD
Study Description
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
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 21 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 |
| Actual Primary Completion Date : | October 28, 2019 |
| Actual Study Completion Date : | October 28, 2019 |
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Change in Quality of Life From Baseline on the CRQ-SR [ Time Frame: baseline and 30 days for each intervention ]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)
Other Outcome Measures:
- 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
- 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.
- 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.
- Difference in Participant 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)
- Amount of Fluid Nebulized [ Time Frame: 30 days, 30 days ]Amount of fluid nebulized (pre- and post-weight of nebulizer) between each device
- Difference in Participant Time to Fill [ Time Frame: 30 days, 30 days ]
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)
- Difference in Participant Time to Sputter [ Time Frame: 30 days, 30 days ]
Time spent using the device will be compared between each device. The following time will be analyzed:
Time to sputter.
Eligibility Criteria
| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Locations
| United States, Pennsylvania | |
| Jefferson Associates in Internal Medicine,LTD | |
| Clairton, Pennsylvania, United States, 15025 | |
Sponsors and Collaborators
Philips Respironics
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 12, 2019 | ||||||
| First Posted Date ICMJE | May 1, 2019 | ||||||
| Results First Submitted Date ICMJE | September 21, 2020 | ||||||
| Results First Posted Date ICMJE | December 17, 2020 | ||||||
| Last Update Posted Date | December 17, 2020 | ||||||
| Actual Study Start Date ICMJE | June 12, 2019 | ||||||
| Actual Primary Completion Date | October 28, 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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.
|
||||||
| Original Primary Outcome Measures ICMJE |
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.
|
||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
Change in Quality of Life From Baseline on the CRQ-SR [ Time Frame: baseline and 30 days for each intervention ] 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)
|
||||||
| Original Secondary Outcome Measures ICMJE |
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)
|
||||||
| Current Other Pre-specified Outcome Measures |
|
||||||
| Original Other Pre-specified Outcome Measures |
|
||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | A Study for the Assessment of the Benefits of a Novel Mesh Nebulizer in the Treatment of Patients With Stable COPD | ||||||
| Official Title ICMJE | A Study for the Assessment of the Benefits of a Novel Mesh Nebulizer in the Treatment of Patients With Stable COPD | ||||||
| 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. |
||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||
| Condition ICMJE | COPD | ||||||
| Intervention ICMJE |
|
||||||
| Study Arms ICMJE |
|
||||||
| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE |
21 | ||||||
| Original Estimated Enrollment ICMJE |
20 | ||||||
| Actual Study Completion Date ICMJE | October 28, 2019 | ||||||
| Actual Primary Completion Date | October 28, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||
| Sex/Gender ICMJE |
|
||||||
| Ages ICMJE | 40 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03933462 | ||||||
| Other Study ID Numbers ICMJE | SRC-RDD-InnospireGo-2018-10458 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
|
||||||
| IPD Sharing Statement ICMJE |
|
||||||
| Responsible Party | Philips Respironics | ||||||
| Study Sponsor ICMJE | Philips Respironics | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE | Not Provided | ||||||
| PRS Account | Philips Respironics | ||||||
| Verification Date | November 2020 | ||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||
