Effectiveness of the Aeroneb in Acute Severe Asthma

May 18, 2023 updated by: Tufts Medical Center

Effectiveness of the Aeroneb Compared to a Jet Nebulizer Fort the Delivery of Bronchodilator Therapy of 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.

Study Overview

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

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Small volume jet nebulizer
Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.
The bronchodilators will be administered via small volume jet nebulizer
Experimental: Aeroneb nebulizer
Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.

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).

Other Names:
  • Vibrating mesh nebulizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Change in Mean of Peak Expiratory Flow Rate (PEFR) Percentage of Predicted Baseline at 30 Minutes After the Initial Bronchodilator Treatment
Time Frame: 30 minutes
Peak expiratory flow rate is the maximum flow rate generated during a forceful exhalation, starting from full inspiration.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Change in the PEFR Percentage of Predicted Baseline to Disposition
Time Frame: Initial bronchodilator treatment to disposition, an average of 4 hours
Change in the PEFR percent predicted from the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group.
Initial bronchodilator treatment to disposition, an average of 4 hours
Percentage Change in the Forced Expiratory Volume (FEV1) Percentage of Predicted Baseline to Disposition
Time Frame: initial bronchodilator treatment to disposition, an average of 4 hours
Forced expiratory volume refers to the volume of air that an individual can exhale during a forced breath in 1 second.
initial bronchodilator treatment to disposition, an average of 4 hours
Change in the Borg-Dyspnea Score From Baseline to Disposition
Time Frame: initial bronchodilator treatment to disposition, an average of 4 hours
The Borg-Dyspnea score measures an individual's effort, exertion, breathlessness and fatigue during physical work. This scale ranges from 6-20 with 6 representing no exertion at all and 20 representing maximal exertion.
initial bronchodilator treatment to disposition, an average of 4 hours
Change in Heart Rate Baseline to Disposition
Time Frame: The initial bronchodilator treatment to to disposition, an average of 4 hours
Change in the heart rate at baseline after the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group.
The initial bronchodilator treatment to to disposition, an average of 4 hours
Length of Stay in the ER
Time Frame: Length of stay in the ER - up to one day
Total length from admission to discharge.
Length of stay in the ER - up to one day
Percentage of Patients Requiring Hospitalization
Time Frame: Length of stay in the ER - up to one day
Total amount of patients requiring hospitalization after ER admission.
Length of stay in the ER - up to one day
The Total Dose of Albuterol Used in Each Group During ED Stay
Time Frame: Length of stay in the ER - up to one day
Albuterol is used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by lung diseases such as asthma and chronic obstructive pulmonary disease.
Length of stay in the ER - up to one day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Total Dose of Ipratropium Used in Each Group During ED Stay
Time Frame: Length of stay in the ER - up to one day
Ipratropium is used to prevent wheezing, shortness of breath, coughing and chest tightness in people with chronic obstructive pulmonary disease, chronic bronchitis, and emphysema. It is a bronchodilator which relaxes and opens the air passages to the lungs to make breathing easier.
Length of stay in the ER - up to one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nicholas S Hill, MD, Tufts Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

January 19, 2017

First Posted (Estimate)

January 24, 2017

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma Exacerbation

Clinical Trials on Small volume jet nebulizer

Subscribe