Effectiveness of the Aeroneb in Acute Severe Asthma

- 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