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 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/04/2005
- Registration date
- 20/04/2005
- Last edited
- 15/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Joanne Langley
Scientific
Scientific
5850 University Avenue
Halifax, Nova Scotia
B3K 6R8
Canada
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Racemic epinephrine |
| Primary outcome measure | 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 study start date | 01/01/1999 |
| Completion date | 31/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 2 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Canada
Study participating centre
5850 University Avenue
Halifax, Nova Scotia
B3K 6R8
Canada
B3K 6R8
Canada
Sponsor information
Lung Association of Nova Scotia (Canada)
Research organisation
Research organisation
17 Alma Crescent
Halifax, Nova Scotia
B3N 3E6
Canada
| Website | http://www.ns.lung.ca/ |
|---|
Funders
Funder type
Research organisation
Lung Association of Nova Scotia (Canada)
No information available
IWK Health Center Research Office (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 05/05/2005 | Yes | No |
