Condition category
Signs and Symptoms
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
11/10/2016
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 Bangalore Satish

ORCID ID

Contact details

Brighton & Sussex University Hospitals NHS Trust (RA)
Royal Alexandra Childrens Hospital
Dyke Road
Brighton
BN1 3JN
United Kingdom
+44 (0)1273 328145 ext. 2213
rah@mistral.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0051096269

Study information

Scientific title

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

Acronym

Study hypothesis

Infants with significant recurrent or persistent wheeze, who have a tendency towards atopy, will improve with inhaled ipratropium bromide.

Ethics approval

Not provided at time of registration

Study design

Randomised double-blind controlled cross-over trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Wheezing

Intervention

Comparison of inhaled ipratropium bromide versus inhaled salbutamol.

Intervention type

Drug

Phase

Not Applicable

Drug names

Ipratropium bromide, salbutamol

Primary outcome measures

Efficacy

Secondary outcome measures

Not provided at time of registration

Overall trial start date

26/04/2001

Overall trial end date

01/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Children aged 3 to 18 months with persistent or recurrent wheezing and atopic tendencies

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

26/04/2001

Recruitment end date

01/06/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Brighton and Sussex University Hospitals NHS Trust (UK)

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

Publication citations

Additional files

Editorial Notes

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