Effectiveness of the Aeroneb in Acute Severe Asthma
Condition: Asthma Exacerbation
MeSH terms: Asthma; Status Asthmaticus
Study type: Interventional

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
    

Intervention name(s): Aeroneb nebulizer; Small volume jet nebulizer
Intervention type(s): Device; Device
Intervention description(s): 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).; The bronchodilators will be administered via small volume jet nebulizer
Other intervention name(s): Vibrating mesh nebulizer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Aeroneb; Aerogen; Bronchodilator