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Aeroneb in asthma exacerbation


Title Effectiveness of the Aeroneb compared to a jet nubulizer for the delivery of bronchodilator therapy of acute severe asthma
Therapeutic Area Asthma
Principal Investigator Nicholas Hill, MD
Min Age 18 Years
Max Age 55 Years
Gender Both
Contact Haval Chweich
617 636-6366
More Information https://clinicaltrials.gov/ct2/show/NCT03029156

Overview

Background: The bronchodilator therapy is an essential component of the management of asthma exacertbation. The delivery of the bronchodilator to the lungs in asthma exacerbations is usually achieved through nebulizing the bronchodilator medications. The commonly used nebulizer device is a small volume jet nebulizer which has not been persistently reliable in delivering the bronchodilator therapy. Aeroneb nebulize device is a FDA approved device which produced consistently respirable sized particles which could potentially result in better bronchodilator effect.

Aim: To study whether Aeroneb nebulizer is more effective than small volume jet nebulizer in delivering bronchodilators in severe asthma exacerbation.

Experiment Design: Patients will be randomized (lie a flip of a coin) to receive the bronchodilator therapy as per the emergency room protocol either via small volume jet nebulizer or Aeroneb nebulizer.

Subjects: Adults patients between the age of 18 and 66 years who present to the emergency room with severe asthma exacerbation with peak respiratory flow rate <50% of predicted.

Study Procedure: When enrolled int he 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 the peak expiratory flow rate.

Study Details

Inclusion Criteria

  • Acute asthma exacerbations presenting to the emergency room
  • Peak expiratory flow rate at presentation< 50% of predicted
  • Enrollment within 90 minutes of the arrival to the ER

Exclusion Criteria

  • History of chronic obstructive pulmonary disease
  • Clinical evidence of acute coronary syndrome
  • Respiratory failure requiring mechanical ventilation either invasive or non-invasive

Study Requirements

The study takes place during the ER visit and requires no further visits for research purposes. The clinical data as well as the peak flow measurement will be collected at the start of the study and at 30 minutes, 60 minutes and 180 minute intervals. There will be a post-enrollment phone interview with 1-2 weeks.