Contact information
Type
Scientific
Primary contact
Dr Clare Murray
ORCID ID
Contact details
North West Lung Research Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 4199
cmurray@fs1.with.man.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
IFWIN
Study hypothesis
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
ERP/97/023, 21st April 1997
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
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Asthma in children
Intervention
Low dose inhaled corticosteroids (fluticasone propionate) versus placebo
Intervention type
Drug
Phase
Not Specified
Drug names
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 trial start date
01/05/1997
Overall trial end date
31/03/2003
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
200
Participant 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
Recruitment start date
01/05/1997
Recruitment end date
31/03/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
North West Lung Research Centre
Manchester
M23 9LT
United Kingdom
Sponsor information
Organisation
Wythenshawe Hospital (UK)
Sponsor details
Andrew Maines
R&D Directorate
ERC Building
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 5775
amaines@fs1.with.man.ac.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
GlaxoSmithKline (UK)
Alternative name(s)
GlaxoSmithKline plc., GSK
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United Kingdom
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
Basic results (scientific)
Publication list
Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16935686
Publication citations
-
Results
Murray CS, Woodcock A, Langley SJ, Morris J, Custovic A, , Secondary prevention of asthma by the use of Inhaled Fluticasone propionate in Wheezy INfants (IFWIN): double-blind, randomised, controlled study., Lancet, 2006, 368, 9537, 754-762, doi: 10.1016/S0140-6736(06)69285-4.