Nebulized N-Acetyl Cysteine for Bronchiolitis in Inpatient Hospital Use

NCT03364218 | Unknown Phase 4 FDA Drug

• 1 other identifier: IRB# 2314
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis Acute

Outcome Measures

Primary Outcomes (3)

• Respiratory Score

  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.

  1. Twice daily by physician 2. 15-30 min pre-treatment by nurse 3. 15-30 and 90 min post-treatment by nurse

• Time on Non-Invasive Ventilation

  Length of time on NIV

  From time of PICU admission to time of PICU discharge, assessed up to 4 weeks

• Duration of PICU/Hospital Admission

  Length of time patient remains hospitalized

  From time of hospital admission to time of hospital discharge, assessed up to 4 weeks

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Subjects will not receive NAC, but will receive standard care for acute bronchiolitis.

Interventions

N-Acetyl Cysteine DRUG

Nebulized N-Acetyl Cysteine administered every 12 hours

Also known as: NAC

Treatment Group

Eligibility Criteria

• Age: 1 Week - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Carilion Clinic

Roanoke, Virginia, 24014, United States

RECRUITING

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Rahul Pandey, MD

  Carilion Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rahul Pandey, MD

CONTACT

9173745746; rkpandey@carilionclinic.org

Virginia Powel, MD

CONTACT

vapowel@carilionclinic.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Pediatric Critical Care Medicine

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 6, 2017
• Study Start: February 1, 2018
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)