Inhaled Fluticasone in Wheezy Infants
| ISRCTN | ISRCTN86717853 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86717853 |
| Protocol serial number | N/A |
| Sponsor | Wythenshawe Hospital (UK) |
| Funder | GlaxoSmithKline (UK) |
- Submission date
- 07/11/2005
- Registration date
- 28/11/2005
- Last edited
- 07/01/2008
- 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 Clare Murray
Scientific
Scientific
North West Lung Research Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
| Phone | +44 (0)161 291 4199 |
|---|---|
| cmurray@fs1.with.man.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A randomized double blind placebo controlled study investigating the effects of early intervention with low dose inhaled corticosteroids (fluticasone propionate) in young children with wheeze |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | IFWIN |
| Study objectives | 1. Can the early introduction of inhaled corticosteroids (ICS) prevent the progressive fall in lung function seen in asthmatics? 2. Can early introduction of inhaled corticosteroids in children with asthma modify the natural history of the disease or prevent recurrence of asthma later in life? 3. Does treatment with ICS reduce symptoms in non-asthmatic wheezy children and improve their lung function at age 6 years? 4. Do inhaled corticosteroids improve the quality of life of families with wheezing children? 5. Is continuous treatment with ICS at this dose in young children associated with any local or systemic side effects? |
| Ethics approval(s) | ERP/97/023, 21st April 1997 |
| Health condition(s) or problem(s) studied | Asthma in children |
| Intervention | Low dose inhaled corticosteroids (fluticasone propionate) versus placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fluticasone propionate |
| Primary outcome measure(s) |
1. Occurrence of asthma at age 5 and 6 |
| Key secondary outcome measure(s) |
1. Rescue and added asthma medication |
| Completion date | 31/03/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 4 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | 1. Children aged 6 months to 4 years 2. Two episodes of doctor verified wheeze or one episode continuous for more than 4 weeks |
| Key exclusion criteria | 1. Pre-term less than 34 weeks gestation 2. Neonatal lung disease or other lung disease 3. Other chronic disease 4. Children already or previously used an inhaled corticosteroid 5. Children who cannot use the spacer device |
| Date of first enrolment | 01/05/1997 |
| Date of final enrolment | 31/03/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
North West Lung Research Centre
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 26/08/2006 | Yes | No |
