Treatment of wheezy infants with bronchodilators (comparison of inhaled ipratropium bromide versus inhaled salbutamol)

ISRCTN ISRCTN22292536
DOI https://doi.org/10.1186/ISRCTN22292536
Secondary identifying numbers N0051096269
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
11/10/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Bangalore Satish
Scientific

Brighton & Sussex University Hospitals NHS Trust (RA)
Royal Alexandra Childrens Hospital
Dyke Road
Brighton
BN1 3JN
United Kingdom

Phone +44 (0)1273 328145 ext. 2213
Email rah@mistral.co.uk

Study information

Study designRandomised double-blind controlled cross-over trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleTreatment of wheezy infants with bronchodilators (comparison of inhaled ipratropium bromide versus inhaled salbutamol)
Study objectivesInfants with significant recurrent or persistent wheeze, who have a tendency towards atopy, will improve with inhaled ipratropium bromide.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedWheezing
InterventionComparison of inhaled ipratropium bromide versus inhaled salbutamol.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Ipratropium bromide, salbutamol
Primary outcome measureEfficacy
Secondary outcome measuresNot provided at time of registration
Overall study start date26/04/2001
Completion date01/06/2003

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit3 Months
Upper age limit18 Months
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteriaChildren aged 3 to 18 months with persistent or recurrent wheezing and atopic tendencies
Key exclusion criteriaNot provided at time of registration
Date of first enrolment26/04/2001
Date of final enrolment01/06/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Brighton & Sussex University Hospitals NHS Trust (RA)
Brighton
BN1 3JN
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Brighton and Sussex University Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

11/10/2016: No publications found, verifying study status with principal investigator.