Effectiveness of the Aeroneb in Acute Severe Asthma

Asthma Exacerbation Clinical Trial

Official title:

Effectiveness of the Aeroneb Compared to a Jet Nebulizer Fort the Delivery of Bronchodilator Therapy of Acute Severe Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03029156
• Other study ID #: 11643
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: August 1, 2019

Study information

• Verified date: May 2023
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 1, 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma Exacerbation
• Status Asthmaticus

Intervention

Device:
• Aeroneb nebulizer
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).
• Small volume jet nebulizer
The bronchodilators will be administered via small volume jet nebulizer

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. Erratum In: J Allergy Clin Immunol. 2008 Jun;121(6):1330. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Total Dose of Ipratropium Used in Each Group During ED Stay	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
Primary	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	Percentage Change in the PEFR Percentage of Predicted Baseline to Disposition	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
Secondary	Percentage Change in the Forced Expiratory Volume (FEV1) Percentage of Predicted Baseline to Disposition	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
Secondary	Change in the Borg-Dyspnea Score From Baseline to Disposition	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
Secondary	Change in Heart Rate Baseline to Disposition	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
Secondary	Length of Stay in the ER	Total length from admission to discharge.	Length of stay in the ER - up to one day
Secondary	Percentage of Patients Requiring Hospitalization	Total amount of patients requiring hospitalization after ER admission.	Length of stay in the ER - up to one day
Secondary	The Total Dose of Albuterol Used in Each Group During ED Stay	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