High-dose Oral Ambroxol for Early Treatment of Pulmonary Acute Respiratory Distress Syndrome: an Exploratory, Randomized, Controlled Pilot Trial.

Abstract

OBJECTIVE:

To evaluate efficacy of high-dose oral ambroxol in acute respiratory distress syndrome (ARDS) with respect to ventilator-free days (VFD).

DESIGN:

Prospective, randomized, placebo-controlled, blinded pilot trial.

PATIENTS:

Sixty-six mechanically ventilated patients (1 month to 12 years) with ARDS who were hand-ventilated for <24 hr before pediatric intensive care unit admission.

INTERVENTIONS:

Patients randomized to oral ambroxol (40 mg/kg/day, in four divided doses) (n = 32) or placebo (n = 34) until 10 days, extubation or death whichever is earlier.

MEASUREMENTS AND MAIN RESULTS:

Majority (91%) had pneumonia and bronchiolitis. Two study groups were similar in baseline characteristics. Mean partial pressure of arterial oxygen/fraction of inspired oxygen and oxygenation index were >175 and <10, respectively, with no difference in the two study groups. VFD were similar in the two study groups. Overall mortality was 26%. No adverse events were noted with ambroxol.

CONCLUSIONS:

Among ventilated pulmonary ARDS patients with oxygenation index of <10, mortality was 26%. Ambroxol did not improve VFD. Study with higher and more frequently administered doses of ambroxol in larger sample is suggested after having generated relevant pharmacokinetic data among critically ill children.

• Authors: Arun K Baranwal, Aparna S Murthy, Sunit C Singhi
• Journal: Journal of tropical pediatrics (J Trop Pediatr) Vol. 61 Issue 5 Pg. 339-50 (Oct 2015) ISSN: 1465-3664 [Electronic] England
• PMID: 26130623 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: © The Author [2015]. Published by Oxford University Press. All rights reserved. For Permissions, please email: [email protected].

Chemical References

• Expectorants
• Ambroxol
• Oxygen

Topics

• Administration, Oral
• Ambroxol (administration & dosage)
• Child
• Child, Preschool
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Expectorants (administration & dosage)
• Female
• Humans
• Infant
• Intensive Care Units
• Intensive Care Units, Pediatric
• Male
• Oxygen (therapeutic use)
• Prospective Studies
• Respiration, Artificial
• Respiratory Distress Syndrome (blood, drug therapy)
• Treatment Outcome