Condition category
Respiratory
Date applied
19/04/2005
Date assigned
20/04/2005
Last edited
15/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Joanne Langley

ORCID ID

Contact details

5850 University Avenue
Halifax
Nova Scotia
B3K 6R8
Canada

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

http://www.ns.lung.ca/

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

  1. 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.

Additional files

Editorial Notes