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Nebulized N-Acetyl Cysteine for Bronchiolitis in Inpatient Hospital Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03364218
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Rahul Pandey, Carilion Clinic

Brief Summary:

Bronchiolitis is the major cause of hospital admission in infants < 6 months of age and usually viruses like Respiratory syncytial virus (RSV), human metapneumo virus, Adeno virus, para-influenza virus, Rhino virus and influenza virus are the main culprit. In the US, acute bronchiolitis in infancy is responsible for approximately 150,000 hospitalizations yearly at an estimated cost of $500 million. Globally in 2005 it was estimated that at least 33.8 million were affected with RSV and in the same year, RSV associated severe acute lower respiratory infection (ALRI) were responsible for ~3.4 million hospitalizations and 66,000-199,000 deaths worldwide, with 99% of these deaths in developing countries.

In acute bronchiolitis there is cellular swelling and excessive mucus production. There is also proliferation of goblet cells, which leads to increased mucus production. The excess mucus produced is poorly cleared by non-ciliated (regenerating) epithelial cells leading to areas of narrowing and blocking of the bronchioles, causing the airway obstruction, hyperinflation, increased airway resistance, atelectasis and increased ventilation-perfusion mismatch that characterize acute bronchiolitis.

Currently there is no medicine that has proven effective in treating acute bronchiolitis and per American Academy of Pediatrics guidelines the management of acute bronchiolitis remains supportive care for the acute respiratory failure associated with acute bronchiolitis.

N-Acetyl Cysteine (NAC) is an antioxidant, anti-mucus compound that increases intracellular glutathione at the cellular level. It cleaves disulfide bonds by converting them to two sulfhydryl groups. This action results in the breakup of mucoproteins in lung mucus, reducing their chain lengths and thinning the mucus. Nebulized NAC is not studied well in acute bronchiolitis and is uncommonly used for the same. NAC has been studied in the treatment of various disease states, including those pulmonary in nature such as cystic fibrosis, chronic bronchitis, non-cystic fibrosis bronchiectasis and found to be beneficial.

With this background knowledge, the purpose of this study is to evaluate the effectiveness of nebulized mucolytic therapy in treatment of children with viral bronchiolitis.


Condition or disease Intervention/treatment Phase
Bronchiolitis Acute Drug: N-Acetyl Cysteine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Nebulized N-Acetyl Cysteine for Bronchiolitis in Inpatient Hospital Use: A Randomized Controlled Trial
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group
Subjects will receive N-Acetyl Cysteine (NAC) nebulized 2 mL of 10% NAC solution every 12 hours during their stay in the Pediatric Intensive Care Unit.
Drug: N-Acetyl Cysteine
Nebulized N-Acetyl Cysteine administered every 12 hours
Other Name: NAC

No Intervention: Control Group
Subjects will not receive NAC, but will receive standard care for acute bronchiolitis.



Primary Outcome Measures :
  1. Respiratory Score [ Time Frame: 1. Twice daily by physician 2. 15-30 min pre-treatment by nurse 3. 15-30 and 90 min post-treatment by nurse ]
    4 item scoring system completed by clinician used to assess respiratory symptoms. Each item is scored 0-3, with the value increasing as severity of symptoms increases.

  2. Time on Non-Invasive Ventilation [ Time Frame: From time of PICU admission to time of PICU discharge, assessed up to 4 weeks ]
    Length of time on NIV

  3. Duration of PICU/Hospital Admission [ Time Frame: From time of hospital admission to time of hospital discharge, assessed up to 4 weeks ]
    Length of time patient remains hospitalized



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Full term new born neonates up to patients < 2yrs
  • Respiratory score ≥2
  • Otherwise healthy with new respiratory illness

Exclusion Criteria:

  • Prematurity <34 weeks for patients <6 months age.
  • h/o congenital heart disease requiring baseline medication
  • Patient received diagnosis of Asthma or reactive airway disease in past.
  • Anatomic airway defect.
  • Immunodeficiency
  • Chronic lung disease
  • Patients who have had previous bronchiolitis < 4 weeks ago
  • Patients intubated for acute bronchiolitis during the current admission.
  • h/o Larynogomlacia, bronchomalacia or tracheomalacia.

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): NCT03364218


Contacts
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Contact: Rahul Pandey, MD 9173745746 rkpandey@carilionclinic.org
Contact: Virginia Powel, MD vapowel@carilionclinic.org

Locations
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United States, Virginia
Carilion Clinic Recruiting
Roanoke, Virginia, United States, 24014
Contact: Rahul Pandey, MD    917-374-5746    rkpandey@carilionclinic.org   
Sponsors and Collaborators
Carilion Clinic
Investigators
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Principal Investigator: Rahul Pandey, MD Carilion Medical Center

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Responsible Party: Rahul Pandey, Assistant Professor, Pediatric Critical Care Medicine, Carilion Clinic
ClinicalTrials.gov Identifier: NCT03364218    
Other Study ID Numbers: IRB# 2314
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes