A randomised controlled trial of racemic epinephrine versus salbutamol for treatment of respiratory distress in bronchiolitis

ISRCTN	ISRCTN46561076
DOI	https://doi.org/10.1186/ISRCTN46561076
Protocol serial number	N/A
Sponsor	Lung Association of Nova Scotia (Canada)
Funders	Lung Association of Nova Scotia (Canada), IWK Health Center Research Office (Canada)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Joanne Langley
Scientific

5850 University Avenue
Halifax, Nova Scotia
B3K 6R8
Canada

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	The protocol was approved by the Ethics Review Board at both participating institutions.
Health condition(s) or problem(s) studied	Bronchiolitis
Intervention	Racemic epinephrine or salbutamol.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Racemic epinephrine
Primary outcome measure(s)	Wheezing and retractions measured by the Respiratory Distress Assessment Instrument each day during hospitalisation.
Key secondary outcome measure(s)	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
Completion date	31/12/2002

Participant type(s)	Patient
Age group	Child
Upper age limit	2 Years
Sex	All
Target sample size at registration	62
Key inclusion criteria	Children less than two years of age with first episode wheezing.
Key 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
Date of first enrolment	01/01/1999
Date of final enrolment	31/12/2002

5850 University Avenue

Halifax, Nova Scotia
B3K 6R8
Canada

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	05/05/2005		Yes	No