Effectiveness of the Aeroneb in Acute Severe Asthma

NCT03029156 | Completed Results

• 1 other identifier: 11643
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma Exacerbation

Keywords

Asthma; Aeroneb; Aerogen; Bronchodilator

Outcome Measures

Primary Outcomes (1)

• Percentage Change in Mean of Peak Expiratory Flow Rate (PEFR) Percentage of Predicted Baseline at 30 Minutes After the Initial Bronchodilator Treatment

  Peak expiratory flow rate is the maximum flow rate generated during a forceful exhalation, starting from full inspiration.

  30 minutes

Secondary Outcomes (7)

• Percentage Change in the PEFR Percentage of Predicted Baseline to Disposition

  Initial bronchodilator treatment to disposition, an average of 4 hours

• Percentage Change in the Forced Expiratory Volume (FEV1) Percentage of Predicted Baseline to Disposition

  initial bronchodilator treatment to disposition, an average of 4 hours

• Change in the Borg-Dyspnea Score From Baseline to Disposition

  initial bronchodilator treatment to disposition, an average of 4 hours

• Change in Heart Rate Baseline to Disposition

  The initial bronchodilator treatment to to disposition, an average of 4 hours

• Length of Stay in the ER

  Length of stay in the ER - up to one day

Other Outcomes (1)

• The Total Dose of Ipratropium Used in Each Group During ED Stay

  Length of stay in the ER - up to one day

Study Arms (2)

Small volume jet nebulizer

ACTIVE COMPARATOR

Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.

Device: Small volume jet nebulizer

Aeroneb nebulizer

EXPERIMENTAL

Administration of bronchodilator via Aeroneb nebulizer. The nebulized solution contains ipratropium / albuterol.

Device: Aeroneb nebulizer

Interventions

Aeroneb nebulizer DEVICE

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).

Also known as: Vibrating mesh nebulizer

Aeroneb nebulizer

Small volume jet nebulizer DEVICE

The bronchodilators will be administered via small volume jet nebulizer

Small volume jet nebulizer

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (10)

• McFadden ER Jr. Acute severe asthma. Am J Respir Crit Care Med. 2003 Oct 1;168(7):740-59. doi: 10.1164/rccm.200208-902SO.

  PMID: 14522812 BACKGROUND

• National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.

  PMID: 17983880 BACKGROUND

• Rodrigo G, Rodrigo C. A new index for early prediction of hospitalization in patients with acute asthma. Am J Emerg Med. 1997 Jan;15(1):8-13. doi: 10.1016/s0735-6757(97)90039-5.

  PMID: 9002561 BACKGROUND

• Rodrigo G, Rodrigo C. Early prediction of poor response in acute asthma patients in the emergency department. Chest. 1998 Oct;114(4):1016-21. doi: 10.1378/chest.114.4.1016.

  PMID: 9792570 BACKGROUND

• Piovesan DM, Menegotto DM, Kang S, Franciscatto E, Millan T, Hoffmann C, Pasin LR, Fischer J, Barreto SS, Dalcin Pde T. Early prognosis of acute asthma in the emergency room. J Bras Pneumol. 2006 Jan-Feb;32(1):1-9. doi: 10.1590/s1806-37132006000100004. English, Portuguese.

  PMID: 17273562 BACKGROUND

• Ari A, Atalay OT, Harwood R, Sheard MM, Aljamhan EA, Fink JB. Influence of nebulizer type, position, and bias flow on aerosol drug delivery in simulated pediatric and adult lung models during mechanical ventilation. Respir Care. 2010 Jul;55(7):845-51.

  PMID: 20587095 BACKGROUND

• Galindo-Filho VC, Ramos ME, Rattes CS, Barbosa AK, Brandao DC, Brandao SC, Fink JB, de Andrade AD. Radioaerosol Pulmonary Deposition Using Mesh and Jet Nebulizers During Noninvasive Ventilation in Healthy Subjects. Respir Care. 2015 Sep;60(9):1238-46. doi: 10.4187/respcare.03667. Epub 2015 Jun 23.

  PMID: 26106207 BACKGROUND

• Alvine GF, Rodgers P, Fitzsimmons KM, Ahrens RC. Disposable jet nebulizers. How reliable are they? Chest. 1992 Feb;101(2):316-9. doi: 10.1378/chest.101.2.316.

  PMID: 1735247 BACKGROUND

• Borg G. Perceived exertion as an indicator of somatic stress. Scand J Rehabil Med. 1970;2(2):92-8. No abstract available.

  PMID: 5523831 BACKGROUND

• Patrick W, Webster K, Ludwig L, Roberts D, Wiebe P, Younes M. Noninvasive positive-pressure ventilation in acute respiratory distress without prior chronic respiratory failure. Am J Respir Crit Care Med. 1996 Mar;153(3):1005-11. doi: 10.1164/ajrccm.153.3.8630538.

  PMID: 8630538 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Nicholas S. Hill
• Organization: Tufts Medical Center

nhill@tuftsmedicalcenter.org

617-636-0688

Study Officials

• Nicholas S Hill, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: January 24, 2017
• Study Start: August 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: August 1, 2019
• Last Updated: May 19, 2023
• Results First Posted: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)