Effectiveness of the Aeroneb in Acute Severe Asthma
Effectiveness of the Aeroneb in Acute Severe Asthma
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.
-  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 40% 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
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