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Mucolytic Agent
Nebulized N-Acetyl Cysteine for Bronchiolitis in Inpatient Hospital Use
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
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Duration of PICU/Hospital Admission
Respiratory Score
Time on Non-Invasive Ventilation
Side effects data
From 2015 Phase 4 trial • 60 Patients • NCT0133985820%
Weight Gain
17%
Nausea and Vomiting
13%
Depressed Mood
10%
Sedation
10%
Dizziness
10%
Upper Respiratory Infection
7%
Insomnia
7%
Headache
7%
Psychosis Exacerbation
7%
Suicidal Ideation
7%
Dyskinesia
7%
Nasal Congestion
7%
Hyperlipidemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sugar Pill
N-Acetyl Cysteine
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
82 Previous Clinical Trials
15,267 Total Patients Enrolled
Rahul Pandey, MD5.03 ReviewsPrincipal Investigator - Carilion Medical Center
Carilion Clinic
1 Previous Clinical Trials
60 Total Patients Enrolled