Effectiveness of the Aeroneb in Acute Severe Asthma
Primary Purpose
Asthma Exacerbation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aeroneb nebulizer
Small volume jet nebulizer
Sponsored by
About this trial
This is an interventional treatment trial for Asthma Exacerbation focused on measuring Asthma, Aeroneb, Aerogen, Bronchodilator
Eligibility Criteria
Inclusion Criteria:
- Acute asthma exacerbations presenting to the emergency room
- Peak expiratory flow rate at presentation <40% of predicted
- Enrolment within 90 minutes of the arrival to the ER
- Age 18-55 years old
Exclusion Criteria:
- History of chronic obstructive pulmonary disease
- Clinical evidence to suggest a non-asthmatic cause of bronchospasm as determined by the treating physician
- Clinical evidence of acute coronary syndrome
- Respiratory failure requiring mechanical ventilation either invasive or non-invasive
- Tachyarrhythmia other than sinus
- Agitated or uncooperative
- Inability to provide informed consent
Sites / Locations
- Tufts Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Small volume jet nebulizer
Aeroneb nebulizer
Arm Description
Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.
Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.
Outcomes
Primary Outcome Measures
Percentage Change in Mean of Peak Expiratory Flow Rate (PEFR) Percentage of Predicted Baseline at 30 Minutes After the Initial Bronchodilator Treatment
Peak expiratory flow rate is the maximum flow rate generated during a forceful exhalation, starting from full inspiration.
Secondary Outcome Measures
Percentage Change in the PEFR Percentage of Predicted Baseline to Disposition
Change in the PEFR percent predicted from the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group.
Percentage Change in the Forced Expiratory Volume (FEV1) Percentage of Predicted Baseline to Disposition
Forced expiratory volume refers to the volume of air that an individual can exhale during a forced breath in 1 second.
Change in the Borg-Dyspnea Score From Baseline to Disposition
The Borg-Dyspnea score measures an individual's effort, exertion, breathlessness and fatigue during physical work. This scale ranges from 6-20 with 6 representing no exertion at all and 20 representing maximal exertion.
Change in Heart Rate Baseline to Disposition
Change in the heart rate at baseline after the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group.
Length of Stay in the ER
Total length from admission to discharge.
Percentage of Patients Requiring Hospitalization
Total amount of patients requiring hospitalization after ER admission.
The Total Dose of Albuterol Used in Each Group During ED Stay
Albuterol is used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by lung diseases such as asthma and chronic obstructive pulmonary disease.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03029156
Brief Title
Effectiveness of the Aeroneb in Acute Severe Asthma
Official Title
Effectiveness of the Aeroneb Compared to a Jet Nebulizer Fort the Delivery of Bronchodilator Therapy of Acute Severe Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
August 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma Exacerbation
Keywords
Asthma, Aeroneb, Aerogen, Bronchodilator
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Small volume jet nebulizer
Arm Type
Active Comparator
Arm Description
Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.
Arm Title
Aeroneb nebulizer
Arm Type
Experimental
Arm Description
Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.
Intervention Type
Device
Intervention Name(s)
Aeroneb nebulizer
Other Intervention Name(s)
Vibrating mesh nebulizer
Intervention Description
The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.
The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium).
Intervention Type
Device
Intervention Name(s)
Small volume jet nebulizer
Intervention Description
The bronchodilators will be administered via small volume jet nebulizer
Primary Outcome Measure Information:
Title
Percentage Change in Mean of Peak Expiratory Flow Rate (PEFR) Percentage of Predicted Baseline at 30 Minutes After the Initial Bronchodilator Treatment
Description
Peak expiratory flow rate is the maximum flow rate generated during a forceful exhalation, starting from full inspiration.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Percentage Change in the PEFR Percentage of Predicted Baseline to Disposition
Description
Change in the PEFR percent predicted from the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group.
Time Frame
Initial bronchodilator treatment to disposition, an average of 4 hours
Title
Percentage Change in the Forced Expiratory Volume (FEV1) Percentage of Predicted Baseline to Disposition
Description
Forced expiratory volume refers to the volume of air that an individual can exhale during a forced breath in 1 second.
Time Frame
initial bronchodilator treatment to disposition, an average of 4 hours
Title
Change in the Borg-Dyspnea Score From Baseline to Disposition
Description
The Borg-Dyspnea score measures an individual's effort, exertion, breathlessness and fatigue during physical work. This scale ranges from 6-20 with 6 representing no exertion at all and 20 representing maximal exertion.
Time Frame
initial bronchodilator treatment to disposition, an average of 4 hours
Title
Change in Heart Rate Baseline to Disposition
Description
Change in the heart rate at baseline after the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group.
Time Frame
The initial bronchodilator treatment to to disposition, an average of 4 hours
Title
Length of Stay in the ER
Description
Total length from admission to discharge.
Time Frame
Length of stay in the ER - up to one day
Title
Percentage of Patients Requiring Hospitalization
Description
Total amount of patients requiring hospitalization after ER admission.
Time Frame
Length of stay in the ER - up to one day
Title
The Total Dose of Albuterol Used in Each Group During ED Stay
Description
Albuterol is used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by lung diseases such as asthma and chronic obstructive pulmonary disease.
Time Frame
Length of stay in the ER - up to one day
Other Pre-specified Outcome Measures:
Title
The Total Dose of Ipratropium Used in Each Group During ED Stay
Description
Ipratropium is used to prevent wheezing, shortness of breath, coughing and chest tightness in people with chronic obstructive pulmonary disease, chronic bronchitis, and emphysema. It is a bronchodilator which relaxes and opens the air passages to the lungs to make breathing easier.
Time Frame
Length of stay in the ER - up to one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute asthma exacerbations presenting to the emergency room
Peak expiratory flow rate at presentation <40% of predicted
Enrolment within 90 minutes of the arrival to the ER
Age 18-55 years old
Exclusion Criteria:
History of chronic obstructive pulmonary disease
Clinical evidence to suggest a non-asthmatic cause of bronchospasm as determined by the treating physician
Clinical evidence of acute coronary syndrome
Respiratory failure requiring mechanical ventilation either invasive or non-invasive
Tachyarrhythmia other than sinus
Agitated or uncooperative
Inability to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas S Hill, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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14522812
Citation
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Effectiveness of the Aeroneb in Acute Severe Asthma
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