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Trial record 96 of 150 for:    Ipratropium OR atrovent

Effectiveness of the Aeroneb in Acute Severe Asthma

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ClinicalTrials.gov Identifier: NCT03029156
Recruitment Status : Completed
First Posted : January 24, 2017
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

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.


Condition or disease Intervention/treatment Phase
Asthma Exacerbation Device: Aeroneb nebulizer Device: Small volume jet nebulizer Not Applicable

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 40% 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of the Aeroneb Compared to a Jet Nebulizer Fort the Delivery of Bronchodilator Therapy of Acute Severe Asthma
Actual Study Start Date : August 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: Small volume jet nebulizer
Administration of bronchodilator through small volume jet nebulizer. The nebulized solution contains ipratropium / albuterol.
Device: Small volume jet nebulizer
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.
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).

Other Name: Vibrating mesh nebulizer




Primary Outcome Measures :
  1. The mean of peak expiratory flow rate (PEFR) percentage of predicted at 30 minutes after the initial bronchodilator treatment [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. Change in the absolute value of PEFR (L/minute) [ Time Frame: 30 minutes after initial bronchodilator treamtent ]

    Secondary outcomes:

    - Change in the absolute value of PEFR (L/minute) at 30 minutes after the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group


  2. Change in the PEFR percentage of predicted [ Time Frame: 60 minutes and 180 minutes after initial bronchodilator treamtent ]
    Change in the PEFR percentage of predicted at 60 minutes and 180 minutes after the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group

  3. Change in the FEV1 percentage of predicted [ Time Frame: 30 minutes, 60 minutes and 180 minutes after the initial bronchodilator treatment ]
    Change in the FEV1 percentage of predicted at 30 minutes, 60 minutes and 180 minutes after the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group

  4. Change in the absolute FEV1 (L/Second) [ Time Frame: at 30 minutes, 60 minutes and 180 minutes after the initial bronchodilator treatment ]
    Change in the absolute FEV1 (L/Second) at 30 minutes, 60 minutes and 180 minutes after the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group

  5. The Borg dyspnea score [ Time Frame: 30 minutes, 60 minutes and 180 minutes after the initial bronchodilator treatment ]
    The Borg dyspnea score at 30 minutes, 60 minutes and 180 minutes after the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group

  6. The accessory muscle use score [ Time Frame: 30 minutes, 60 minutes and 180 minutes after the initial bronchodilator treatment ]
    The accessory muscle use score at 30 minutes, 60 minutes and 180 minutes after the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group

  7. Heart rate [ Time Frame: 30 minutes, 60 minutes and 180 minutes after the initial bronchodilator treatment ]
    The heart rate at 30 minutes, 60 minutes and 180 minutes after the initial bronchodilator treatment in the Aeroneb group compared to the small volume jet nebulizer group

  8. Length of stay in the ER [ Time Frame: Lenth of stay in the ER - up to one day ]
  9. Percentage of patients requiring hospitalization [ Time Frame: Lenth of stay in the ER - up to one day ]
  10. The total dose of albuterol used in each group [ Time Frame: Lenth of stay in the ER - up to one day ]

Other Outcome Measures:
  1. The total dose of ipratropium used in each group [ Time Frame: Lenth of stay in the ER - up to one day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029156


Locations
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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Investigators
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Principal Investigator: Nicholas S Hill, MD Tufts Medical Center

Publications of Results:

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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT03029156     History of Changes
Other Study ID Numbers: 11643
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tufts Medical Center:
Asthma
Aeroneb
Aerogen
Bronchodilator
Additional relevant MeSH terms:
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Ipratropium
Asthma
Status Asthmaticus
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents