Treatment of wheezy infants with bronchodilators (comparison of inhaled ipratropium bromide versus inhaled salbutamol)
| ISRCTN | ISRCTN22292536 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22292536 |
| Protocol serial number | N0051096269 |
| Sponsor | Department of Health (UK) |
| Funder | Brighton and Sussex University Hospitals NHS Trust (UK) |
- 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
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 |
|---|---|
| rah@mistral.co.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind controlled cross-over trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Treatment of wheezy infants with bronchodilators (comparison of inhaled ipratropium bromide versus inhaled salbutamol) |
| Study objectives | Infants 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) studied | Wheezing |
| Intervention | Comparison of inhaled ipratropium bromide versus inhaled salbutamol. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ipratropium bromide, salbutamol |
| Primary outcome measure(s) |
Efficacy |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Months |
| Upper age limit | 18 Months |
| Sex | All |
| Key inclusion criteria | Children aged 3 to 18 months with persistent or recurrent wheezing and atopic tendencies |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 26/04/2001 |
| Date of final enrolment | 01/06/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Brighton & Sussex University Hospitals NHS Trust (RA)
Brighton
BN1 3JN
United Kingdom
BN1 3JN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/10/2016: No publications found, verifying study status with principal investigator.
