"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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Experimental: Treatment group||
Drug: N acetyl cysteine nebulized
10% nebulized solution of NAC will be used BID
|No Intervention: non treatment group|
- Symptoms compared to the standard supportive care: using the bronchiolitis scoring system. [ Time Frame: 2-3 years ]
- Reduce duration spend on non-invasive ventilation [ Time Frame: 2-3 years ]
- Decrease PICU/hospital stay. [ Time Frame: 2-3 years ]
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
|Contact: Rahul Pandey, MDemail@example.com|
|Contact: Virginia Powel, MDfirstname.lastname@example.org|