Effectiveness of the Aeroneb in Acute Severe Asthma

Study Overview
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Brief Summary
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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
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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

Official Title
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Effectiveness of the Aeroneb Compared to a Jet Nebulizer Fort the Delivery of Bronchodilator Therapy of Acute Severe Asthma

Conditions
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Asthma Exacerbation

Intervention / Treatment
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* Device: Aeroneb nebulizer
* Device: Small volume jet nebulizer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Small volume jet nebulizer<br>Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol. | Device: Small volume jet nebulizer<br>* The bronchodilators will be administered via small volume jet nebulizer<br>|
| Experimental: Aeroneb nebulizer<br>Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol. | Device: Aeroneb nebulizer<br>* 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).<br>* Other names: Vibrating mesh nebulizer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Initial bronchodilator treatment to disposition, an average of 4 hours | 
| 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. | initial bronchodilator treatment to disposition, an average of 4 hours | 
| 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. | initial bronchodilator treatment to disposition, an average of 4 hours | 
| 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. | The initial bronchodilator treatment to to disposition, an average of 4 hours | 
| Length of Stay in the ER | Total length from admission to discharge. | Length of stay in the ER - up to one day | 
| Percentage of Patients Requiring Hospitalization | Total amount of patients requiring hospitalization after ER admission. | Length of stay in the ER - up to one day | 
| 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. | Length of stay in the ER - up to one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Aeroneb, Aerogen, Bronchodilator