Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Aerosolised racemic epinephrine given to hospitalised children under two years of age with bronchiolitis is more effective than aerosolised salbutomol in relieving respiratory distress.
Ethics approval
The protocol was approved by the Ethics Review Board at both participating institutions.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Bronchiolitis
Intervention
Racemic epinephrine or salbutamol.
Intervention type
Drug
Phase
Not Specified
Drug names
Racemic epinephrine
Primary outcome measures
Wheezing and retractions measured by the Respiratory Distress Assessment Instrument each day during hospitalisation.
Secondary outcome measures
1. Length of stay
2. RSV antigen detection test
3. Feeding pattern
4. Adverse events
5. Parental report of feeding and respiratory status one week after discharge
Overall trial start date
01/01/1999
Overall trial end date
31/12/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Children less than two years of age with first episode wheezing.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
62
Participant exclusion criteria
Children were not eligible for enrollment if they:
1. Had a previous diagnosis of asthma
2. Were critically ill
3. Had chronic pulmonary or cardiac disease
Other exclusion criteria included:
4. Allergy to sodium metabisulfite
5. Presence of tachycardia exceeding 200 beats per minute
6. Use of glucocorticoids
7. Sympathomimetic amines or monoamine oxidase inhibitor therapy
Recruitment start date
01/01/1999
Recruitment end date
31/12/2002
Locations
Countries of recruitment
Canada
Trial participating centre
5850 University Avenue
Halifax, Nova Scotia
B3K 6R8
Canada
Sponsor information
Organisation
Lung Association of Nova Scotia (Canada)
Sponsor details
17 Alma Crescent
Halifax
Nova Scotia
B3N 3E6
Canada
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Lung Association of Nova Scotia (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
IWK Health Center Research Office (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/15876347
Publication citations
-
Results
Langley JM, Smith MB, LeBlanc JC, Joudrey H, Ojah CR, Pianosi P, Racemic epinephrine compared to salbutamol in hospitalized young children with bronchiolitis; a randomized controlled clinical trial [ISRCTN46561076]., BMC Pediatr, 2005, 5, 1, 7, doi: 10.1186/1471-2431-5-7.