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"Nebulized N-Acetyl Cysteine for Bronchiolitis in Inpatient Hospital Use: A Randomized Controlled Trial" Inpatient Hospital Use: A Randomized Controlled Trial"

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ClinicalTrials.gov Identifier: NCT03364218
Recruitment Status : Not yet recruiting
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Rahul Pandey, Carilion Clinic

Brief Summary:

Bronchiolitis is the major cause of hospital admission in infants under 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 United States, acute bronchiolitis in infancy is responsible for approximately 150000 hospitalizations each year at an estimated cost of $500 million. Globally in 2005 year it is estimated that atleast 33.8 million were affected with RSV alone and in the same year, RSV associated severe acute lower respiratory infection (ALRI) were responsible for ~3.4 million hospitalizations and 66000 to 199000 deaths worldwide, with 99% of these deaths occurring in developing countries.

In acute bronchiolitis there is cellular swelling and excessive mucus production. There is also proliferation of goblet cells, which also leads to increased mucus production. The excessive 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 shown to be effective in treating acute bronchiolitis and as per the 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. Currently there is only one study in literature by Naz F et el published in 2014 where nebulized NAC with nebulized Albuterol in acute bronchiolitis and it showed significant improvement in clinical severity scores as documented in that study


Condition or disease Intervention/treatment Phase
Bronchiolitis Acute Drug: N acetyl cysteine nebulized Phase 4

  Show Detailed Description

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"
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment group Drug: N acetyl cysteine nebulized
10% nebulized solution of NAC will be used BID

No Intervention: non treatment group



Primary Outcome Measures :
  1. Symptoms compared to the standard supportive care: using the bronchiolitis scoring system. [ Time Frame: 2-3 years ]
  2. Reduce duration spend on non-invasive ventilation [ Time Frame: 2-3 years ]
  3. Decrease PICU/hospital stay. [ Time Frame: 2-3 years ]


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

Sponsors and Collaborators
Carilion Clinic

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

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:
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