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Mucolytic Agent
Treatment Group for Bronchiolitis
Phase 4
Waitlist Available
Led By Rahul Pandey, MD
Research Sponsored by Carilion Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1. twice daily by physician 2. 15-30 min pre-treatment by nurse 3. 15-30 and 90 min post-treatment by nurse
Awards & highlights
Study Summary
This trial is studying nebulized N-acetylcysteine (NAC) to see how well it works compared to placebo in treating viral bronchiolitis in children.
Eligible Conditions
- Bronchiolitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1. twice daily by physician 2. 15-30 min pre-treatment by nurse 3. 15-30 and 90 min post-treatment by nurse
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1. twice daily by physician 2. 15-30 min pre-treatment by nurse 3. 15-30 and 90 min post-treatment by nurse
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of PICU/Hospital Admission
Respiratory Score
Time on Non-Invasive Ventilation
Side effects data
From 2015 Phase 4 trial • 60 Patients • NCT0133985813%
Depressed Mood
10%
Insomnia
10%
Headache
10%
Illness Exacerbation
10%
Nausea and Vomiting
10%
Weight Gain
7%
Diarrhea
7%
Psychosis Exacerbation
7%
Sedation
7%
Toothache
7%
Dizziness
7%
Upper Respiratory Infection
7%
Rash
7%
Dyspepsia
3%
Asthma Exacerbation
3%
Nasal Congestion
100%
80%
60%
40%
20%
0%
Study treatment Arm
N-Acetyl Cysteine
Sugar Pill
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment GroupExperimental Treatment1 Intervention
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.
Group II: Control GroupActive Control1 Intervention
Subjects will not receive NAC, but will receive standard care for acute bronchiolitis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cysteine
FDA approved
Find a Location
Who is running the clinical trial?
Carilion ClinicLead Sponsor
72 Previous Clinical Trials
12,656 Total Patients Enrolled
Rahul Pandey, MD5.03 ReviewsPrincipal Investigator - Carilion Medical Center
Carilion Clinic
1 Previous Clinical Trials
60 Total Patients Enrolled
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