Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-04 @ 7:35 AM
Study NCT ID:
NCT03029156
Status:
COMPLETED
Last Update Posted:
2023-05-19
First Post:
2016-07-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of the Aeroneb in Acute Severe Asthma
Sponsor:
Tufts Medical Center
Organization:
Study Overview
Official Title:
Effectiveness of the Aeroneb Compared to a Jet Nebulizer Fort the Delivery of Bronchodilator Therapy of Acute Severe Asthma
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background: The bronchodilator therapy is an essential component of the management of asthma exacerbation. The delivery of bronchodilators to the lungs in asthma exacerbations is usually achieved through nebulization (creating small particles to be inhaled). The commonly used nebulizer device is a small volume jet nebulizer which has not been consistently reliable in delivering bronchodilator therapy. The Aeroneb nebulizer device is a FDA approved device which produces consistently respirable sized particles which could potentially result in better bronchodilator effect than the standard jet nebulizer.
Aim: To study whether the Aeroneb nebulizer is more effective than a small volume jet nebulizer in delivering bronchodilators during a severe asthma exacerbation.
Experimental design: Patients will be randomized (like a flip of a coin) to receive bronchodilator therapy as per the emergency room protocol either via small volume jet nebulizer or Aeroneb nebulizer.
Subjects: Adult patients between age of 18 and 55 years who present to the emergency room with severe asthma exacerbation with peak expiratory flow rate \<50% of predicted.
Study procedure: When enrolled in the study and after randomization, we will then collect data that is standard for the hospital like heart rate, blood pressure and breathing indices and also some non-routine things like some scoring scales for shortness of breath and serial measurements of peak expiratory flow rate. We anticipate that the Aeroneb device will be more effective in delivering bronchodilator medication and thus more effective in managing asthma exacerbations.
Aim: To study whether the Aeroneb nebulizer is more effective than a small volume jet nebulizer in delivering bronchodilators during a severe asthma exacerbation.
Experimental design: Patients will be randomized (like a flip of a coin) to receive bronchodilator therapy as per the emergency room protocol either via small volume jet nebulizer or Aeroneb nebulizer.
Subjects: Adult patients between age of 18 and 55 years who present to the emergency room with severe asthma exacerbation with peak expiratory flow rate \<50% of predicted.
Study procedure: When enrolled in the study and after randomization, we will then collect data that is standard for the hospital like heart rate, blood pressure and breathing indices and also some non-routine things like some scoring scales for shortness of breath and serial measurements of peak expiratory flow rate. We anticipate that the Aeroneb device will be more effective in delivering bronchodilator medication and thus more effective in managing asthma exacerbations.
Detailed Description:
* Patients presenting with acute severe asthma exacerbations to the emergency room will be screened by the PI, co-investigator or research coordinator to determine their eligibility based on the inclusion and exclusion criteria.
* Clinically indicated treatment must not be delayed for a research-related reason so patients will still be eligible for enrollment after receiving initial bronchodilator therapy as long as their PEFR remains \<50% of predicted and enrollment occurs within 90 minutes of the ER arrival time.
* The initial part of the consent process will cover the essential elements of the informed consent in a concise manner to ensure a timely process
* Eligible patients will be randomized using the concealed envelope method to either the intervention arm or the control arm. The randomization should take place within 90 minutes of ER arrival, however, every effort will be made to enroll the patient as soon as possible; patients will be enrolled as long as their PEFR is less than 50% of predicted regardless of the number of bronchodilator treatments they received prior to randomization.
* The assignment will be blinded to the recording investigator and the treating physician but not to the patient or the nurse or respiratory therapist who is administering the nebulization. In order to avoid any delay in administering the treatments, the sets of Aeroneb nebulizer and small volume jet nebulizer will be stored in identical boxes and will be readily available in the ER.
In order to blind the treating physician and the recording investigator, a sign "treatment in progress" will be displayed at the outdoor of the ER room when the patient is getting the bronchodilator treatment. The nebulizer devices will be placed in the box between the bronchodilator treatment sessions. The physician and the recording investigator will be asked if possible to see the patients only when the sign is taken off the outdoor.
* Once assigned, all the bronchodilator treatments in the ER will be administered using the nebulizer device assigned to that patient.
* The Peak flow and FEV1 will be measured using Spirometer (micro I). Both values will be obtained through the same exhalation maneuver.
* Patient will be treated and managed according to the asthma ER adult protocol or as directed by the ER physician who is in charge of patient's care
* After the study procedures have been performed and the subject is determined to be in stable condition and have the capacity to make medical decisions, the investigator will approach the subject again and review all the elements of the ICF again with the subject. The collected data will be used only if the subject signs both parts of the informed consent.
* Within two weeks of the subject participation, the research team will conduct a phone interview with the subject to obtain their feedback on the study procedures and mainly on the informed consent process. The phone interview questionnaire is included in the supplement
* Clinically indicated treatment must not be delayed for a research-related reason so patients will still be eligible for enrollment after receiving initial bronchodilator therapy as long as their PEFR remains \<50% of predicted and enrollment occurs within 90 minutes of the ER arrival time.
* The initial part of the consent process will cover the essential elements of the informed consent in a concise manner to ensure a timely process
* Eligible patients will be randomized using the concealed envelope method to either the intervention arm or the control arm. The randomization should take place within 90 minutes of ER arrival, however, every effort will be made to enroll the patient as soon as possible; patients will be enrolled as long as their PEFR is less than 50% of predicted regardless of the number of bronchodilator treatments they received prior to randomization.
* The assignment will be blinded to the recording investigator and the treating physician but not to the patient or the nurse or respiratory therapist who is administering the nebulization. In order to avoid any delay in administering the treatments, the sets of Aeroneb nebulizer and small volume jet nebulizer will be stored in identical boxes and will be readily available in the ER.
In order to blind the treating physician and the recording investigator, a sign "treatment in progress" will be displayed at the outdoor of the ER room when the patient is getting the bronchodilator treatment. The nebulizer devices will be placed in the box between the bronchodilator treatment sessions. The physician and the recording investigator will be asked if possible to see the patients only when the sign is taken off the outdoor.
* Once assigned, all the bronchodilator treatments in the ER will be administered using the nebulizer device assigned to that patient.
* The Peak flow and FEV1 will be measured using Spirometer (micro I). Both values will be obtained through the same exhalation maneuver.
* Patient will be treated and managed according to the asthma ER adult protocol or as directed by the ER physician who is in charge of patient's care
* After the study procedures have been performed and the subject is determined to be in stable condition and have the capacity to make medical decisions, the investigator will approach the subject again and review all the elements of the ICF again with the subject. The collected data will be used only if the subject signs both parts of the informed consent.
* Within two weeks of the subject participation, the research team will conduct a phone interview with the subject to obtain their feedback on the study procedures and mainly on the informed consent process. The phone interview questionnaire is included in the supplement
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: