drugset / Trial / NCT00622817

The Influence of Inhaled Adrenalin Versus Decongestant as a Local Nasal Treatment in Bronchiolitis

NCT00622817

RandomizedParallel-groupDouble-blindTreatment

Summary

This was a randomized, double blinded, controlled trial. The aim of the study was to compare xylometazoline HCL nasal drops to inhalation of epinephrine as a treatment for bronchiolitis. The study hypothesis is:xylometazoline HCL nasal drops treatment is good as epinephrine inhalation for treatment of bronchiolitis. Signed informed consent was obtained from a parent of each child. And the human ethics committee of our hospital approved the study according to the principles of the Declaration of Helsinki.(Approved - 2002) Patients: 65 infants who were admitted to Pediatric A- a general pediatric ward, in Schneider Children's Medical Center because of bronchiolitis during winter in two consecutive years 2004-2005. The inclusion criteria were: Full term previously healthy Infants, ages 1-12 months, after informed consent was signed with clinical presentation of mild to moderate bronchiolitis according to a clinical score .Exclusion criteria were as follows: prematurity, congenital lung or cardiac disease, infants who had past hospitalization due to respiratory illness and severe bronchiolitis (score\>7 with a range scale 0-10).

Timeline

Start
2004-10
Primary completion
2005-03
Completion
2005-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Epinephrine Other / unclassified 1 mg Inhaled
Subject Xylometazoline Small molecule 0.05 % Intranasal

Indications