Inhaled Fluticasone in Wheezy Infants
| ISRCTN | ISRCTN86717853 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86717853 |
| Secondary identifying numbers | N/A |
- 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
| 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 |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fluticasone propionate |
| Primary outcome measure | 1. Occurrence of asthma at age 5 and 6 2. Lung function at age 5 3. Non-specific bronchial hyper-reactivity at age 5 4. Number of courses and total dose of add-on fluticasone propionate required |
| Secondary outcome measures | 1. Rescue and added asthma medication 2. Number of exacerbations 3. Safety parameters length/height, weight 4. Symptom scores 5. Adrenal function |
| Overall study start date | 01/05/1997 |
| Completion date | 31/03/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 4 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
North West Lung Research Centre
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Sponsor information
Wythenshawe Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
Andrew Maines
R&D Directorate
ERC Building
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
England
United Kingdom
| Phone | +44 (0)161 291 5775 |
|---|---|
| amaines@fs1.with.man.ac.uk | |
"ROR" |
https://ror.org/05vpsdj37 |
Funders
Funder type
Industry
GlaxoSmithKline (UK)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- GlaxoSmithKline plc., GSK plc., GSK
- Location
- United Kingdom
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 | 26/08/2006 | Yes | No |
