Mode
Text Size
Log in / Sign up
N/A N=31 Randomized Single-blind Treatment

Effectiveness of the Aeroneb in Acute Severe Asthma

Asthma Exacerbation

Enrolled (actual)
31
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Percentage Change in Mean of Peak Expiratory Flow Rate (PEFR) Percentage of Predicted Baseline at 30 Minutes After the Initial Bronchodilator Treatment — 18.1; 12.9 percent change

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Aeroneb nebulizer (Device); Small volume jet nebulizer (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Tufts Medical Center
Primary completion
Dec 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage Change in Mean of Peak Expiratory Flow Rate (PEFR) Percentage of Predicted Baseline at 30 Minutes After the Initial Bronchodilator Treatment
18.1; 12.9
SECONDARY
Percentage Change in the PEFR Percentage of Predicted Baseline to Disposition
23.3; 14.4
SECONDARY
Percentage Change in the Forced Expiratory Volume (FEV1) Percentage of Predicted Baseline to Disposition
17.1; 8.0
SECONDARY
Change in the Borg-Dyspnea Score From Baseline to Disposition
2.44; 3.15
SECONDARY
Change in Heart Rate Baseline to Disposition
1; 1
SECONDARY
Length of Stay in the ER
272.3; 245.3
SECONDARY
Percentage of Patients Requiring Hospitalization
4; 6
SECONDARY
The Total Dose of Albuterol Used in Each Group During ED Stay
6.3; 7.2

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03029156). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search